June 5, 1981
CDC Reports Initial Cases of HIV/AIDS in Los Angeles

U.S. Centers for Disease Control and Prevention reports cases of a rare lung infection, Pneumocystis carinii pneumonia, in five young, previously healthy, gay men in Los Angeles.

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The CDC’s Morbidity and Mortality Weekly Report described the men as having additional infections, indicating that their immune systems were compromised. Two of the young men were already dead by the time the report was published.

The edition of the MMWR marked the first official reporting of what would become known as the AIDS epidemic. The initial five-patient study was reported to the CDC by Dr. Michael Gottlieb, a young immunologist at UCLA (University of California Los Angeles).

Dr. Gottlieb encountered his first patient with unusual infections in November 1980, when one of his medical school residents reported a young patient suffering from a severe yeast infection in his throat.  When the patient began having breathing difficulties, Dr. Gottlieb arranged to receive a scraping of his lung tissue through a non-surgical procedure.  He was astounded by the test results.

The patient tested positive for Pneumocystis carinii pneumonia (PCP) in addition to oral candidiasis, also known as thrush.  Dr. Gottlieb then reached out to a colleague who specialized in the new science of T-cells, the white blood cells important to the immune system.  The colleague tested the patient’s blood and found that the sample had no T-helper cells, a result so astounding that he ran the test again, with the same results.

In February 1981, Dr. Gottlieb would come across another young man suffering with Pneumocystis carinii pneumonia (PCP) and depleted T-cells, and shortly after that, a third patient was referred to him.  Thorough examinations of the patients about their lifestyles yielded the information that were gay, but Dr. Gottlieb couldn’t determine how their sexual identity was relevent.

A fourth PCP patient appeared in April 1981, and then a report of a fifth man who already died (an autopsy found PCP).   Seeing an alarming trend, Dr. Gottlieb contacted an editor at the New England Journal of Medicine, the most prestigious medical journal in the U.S., and was told that the submission-review-publication process would take at least four months.  He believed this information needed to get out to the medical community fast, so he instead submitted his report to the CDC’s weekly newsletter, the Morbidity and Mortality Weekly Report (MMWR), a weekly report read by medical officials concerned with infectious disease and public health.

Assisting Dr. Gottlieb in publishing his report was Dr. Wayne Shandera, who worked in the Los Angeles County Department of Public Health as a CDC liaison.

“Gottlieb talked through the charts while Shandera put the information into the dry, turgid prose that the MMWR preferred,” wrote Randy Shilts in his epic recounting of the early years of the AIDS pandemic, And the Band Played On: Politics, People, and the AIDS Epidemic.  “The report noted the links between PCP, CMV (cytomegalovirus), and the oral candidiasis that commonly preceded the pneumonia.”

Dr. Gottlieb’s report also stated, “The fact that these patients were all homosexuals suggests an association between some aspect of homosexual lifestyle or disease acquired through sexual contact and Pneumocystis pneumonia in this population.”

Of course, the five Los Angeles men in Dr. Gottlieb’s report were not the only early cases of the disease that years later would be called AIDS.  In 1979, 1980 and 1981, previously healthy men in New York City and San Francisco were their seeing doctors and baffling them with a range of symptoms that included fatigue, enlarged lymph nodes, flat purple lesions, oral candidiasis, shortness of breath, eczema, fevers, and amebic dysentery.  Their medical charts would be marked with notes like “fever of unknown origin,” “Kaposi’s sarcoma,” “cytomegalovirus,” and “toxoplasmosis.”   But the traditional treatments for these conditions were not working.

Now it is known that HIV originated much earlier, around 1920, likely in the Democratic Republic of Congo when HIV crossed species from chimpanzees to humans.  Up until the 1980s, there is no record of how many people were infected with HIV or developed AIDS.

While sporadic cases of AIDS were documented prior to 1970, available data suggests that the epidemic started in the mid- to late 1970s.  By 1980, HIV may have already spread to five continents (North America, South America, Europe, Africa and Australia), and in this period, it is possible that up to 300,000 people were already infected.

In April of 1980, the CDC received a report on Ken Horne, a gay man in San Francisco who was diagnosed with Kaposi’s sarcoma.  Horne died on November 30, 1981.  The CDC would retroactively identify Horne as the first American patient of the AIDS epidemic.

Following Dr. Gottlieb’s report in the CDC’s MMWR, he and his team published a more detailed report in the New England Journal of Medicine on December 10,  1981.

Today, Dr. Gottlieb is an Associate Clinical Professor of Medicine at UCLA’s David Geffen School of Medicine and still treats patients exclusively at AIDS Project Los Angeles (APLA Health).  He is also a member of the Council of Advisors to STORIES: The AIDS Monument.

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Morbidity and Mortality Weekly Report | Centers for Disease Control and Prevention, “Pneumocystis Pneumonia – Los Angeles,” June 5, 1981

American Journal of Managed Care, “A Q&A With HIV/AIDS Pioneer Dr Michael Gottlieb” by Maggie L. Shaw, June 4, 2021

And the Band Played On: Politics, People, and the AIDS Epidemic by Randy Shilts

www.Be In The Know.org, “Origin of HIV and AIDS”

PBS News Hour, “America’s HIV Outbreak Started in This City, 10 Years Before Anyone Noticed” by Nsikan Akpan, October 26, 2016

www.History.com | A&E Television Networks, “AIDS Crisis Timeline”

The New England Journal of Medicine“Pneumocystis carinii Pneumonia and Musocal Candidiasis in Previously Healthy Homosexual Men — Evidence of a New Acquired Cellular Immunodeficiency” by Michael S. Gottlieb, M.D., Robert Schroff, Ph.D., Howard M. Schanker, M.D., Joel D. Weisman, D.O., Peng Thim Fan, M.D., Robert A. Wolf, M.D., and Andrew Saxon, M.D.; December 10, 1981

Rare Kaposi’s Sarcoma Found among Gay Men in NY & CA

New York City dermatologist Dr. Alvin Friedman-Kien calls the CDC to report a cluster of cases of a rare and unusually aggressive cancer — Kaposi’s Sarcoma — among gay men in New York and California.

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Like pnuemocytis carinii pneumonia (PCP), Kaposi’s Sarcoma (KS) is associated with people who have weakened immune systems.

Dr. Friedman-Kien told New York magazine:

“In February 1981, I saw a young man who was perfectly healthy except for a number of spots on his skin.  I’d never seen anything like it, so I did a biopsy.  Under the microscope, the cell structure was clear: it was Kaposi’s sarcoma.”

Dr. Friedman-Kien continued:  “A week later, another physician sent me another patient, also a gay man in his late thirties, also with disseminated KS.”

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New York magazine, “Fighting AIDS” by Janice Hopkins Tanne, January 12, 1987

POZ magaine, “A Look Back at the Year a Rare Cancer Was First Seen in Gay Men” by Joseph Sonnabend, M.D., July 13, 2020

The New York Times, “Rare Cancer Seen in 41 Homosexuals” by Lawrence K. Altman, July 3, 1981

June 8, 1981
CDC Report Receives Nationwide Media Attention

News media begin to report out on the MMWR article, and within days, the CDC receives reports from around the country of similar cases of opportunistic infections among gay men.

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These news stories — which were published by the Los Angeles Times, San Francisco Chronicle and Associated Press — captured the attention of the gay community and medical personnel nationwide.

In response to the outpouring of reports and concerns to the CDC, the Task Force on Kaposi’s Sarcoma and Opportunistic Infections was created to identify risk factors and to develop a case definition for the as-yet-unnamed syndrome.  The Task Force worked under the CDC’s Field Services Division in the Epidemiology Program.

To coordinate the task force, the CDC selected James W. Curran, M.D., who would dedicate much of his life to HIV/AIDS research and would publish numerous research papers on the disease.

Task force members included David M. Auerbach, M.D.; John V. Bennett, M.D.; Philip S. Brachman, M.D.; Glyn C. Caldwell, M.D.; Salvatore J. Crispi; William W. Darrow, Ph.D.; Henry Falk, M.D.; David S. Gordon, M.D.; Mary E. Guinan, M.D.; Harry W. Haverkos, M.D.; Clark W. Heath, Jr., M.D.; Roy T. Ing, M.D.; Harold W. Jaffe, M.D.; Bonnie Mallory Jones; Dennis D. Juranek, D.V.M.; Alexander Kelter, M.D.; J. Michael Lane, M.D.; Dale N. Lawrence, M.D.; Richard Ludlow; Cornelia R. McGrath; James M. Monroe; David M. Morens, M.D.; John P. Orkwis; Martha F. Rogers, M.D.; Wilmon R. Rushing; Richard W. Sattin, M.D.; Mary Ellen Shapiro; Thomas J. Spira, M.D.; John A. Stewart, M.D.; Pauline A. Thomas, M.D.; and Hilda Westmoreland.

In its first year, the Task Force on Kaposi’s Sarcoma and Opportunistic Infections received case reports from the following doctors working in New York, San Francisco and Los Angeles:

Donald F. Austin, M.D.; Erwin Braff, M.D.; James W. Buehler, M.D.; James Chin, M.D.; J. Lyle Conrad, M.D.; Selma Dritz, M.D.; Diane M. Dwyer, M.D.; Shirley L. Fannin, M.D.; Yehudi M. Felman, M.D.; Stephen M. Friedman, M.D.; Robert A. Gunn, M.D.; John P. Hanrahan, M.D.; Robert J. Kingon, M.D.; Michael D. Malison, M.D.; Stanley I. Music, M.D.; Mark A. Roberts, M.D.; Alain J. Roisin, M.D.; Richard B. Rothenberg, M.D.; and R. Keith Sikes, M.D.

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National Institutes of Health“In Their Own Words … NIH Researchers Recall the Early Years of AIDS”

Frontline | PBS “Interview: Jim Curran,” interviews conducted Jan. 18, 2005 and Feb. 15, 2006

The New England Journal of Medicine, “Epidemiologic Aspects of the Current Outbreak of Kaposi’s Sarcoma and Opportunistic Infections,” January 28, 1982

June 16, 1981
First Person with AIDS Admitted to NIH

A man exhibiting symptoms of severe immunodeficiency is the first person with AIDS to be admitted to the Clinical Center at the National Institutes of Health.

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The 35-year-old, white gay man from New York City was transferred from a Connecticut hospital to the NIH in Bethesda, Maryland after researchers at the National Cancer Institute, an NIH branch that studied immunodeficiency diseases, heard about his case.

Almost immediately after the new disease emerged on the medical scene, researchers recognized that patients with this unnamed syndrome often developed a rare cancer called Kaposi’s sarcoma as well as other tumors, such as high-grade B-cell lymphomas. As a result, some of the earliest AIDS patient care and research was performed by cancer specialists at the NIH and elsewhere.

The man admitted to the NIH was, for privacy purposes, referred to as “Patient D.”  He came to the NIH from Hartford Hospital, where he had been hospitalized for two months with neumocystis carinii pneumonia, lymphocytopenia, cytomegalovirus, herpes simplex II, Candida esophagitis, and Mycobacterium avium tuberculosis of the lung, bone marrow, and esophagus.

The patient had been healthy through adulthood until February 1981, when he began experiencing fatigue and weakness, followed by weight loss and fever.

Thomas A. Waldmann, M.D., one of the NIH doctors who was first to examine “Patient D” said in a 1990 NIH interview:

“The pattern that we observed in our patient was the kind of pattern one saw in Hodgkin’s disease patients who were profoundly anergic [i.e., a condition in which the body fails to react to an antigen], or in patients with a form of profound immunodeficiency called ‘severe combined immunodeficiency of infancy,’ where the patient cannot make an effective cellular or antibody immune response. What we were seeing was an acquired form of cell-mediated immunity.”

Dr. Waldmann said the medical team performed every test they could think of to try to determine the cause of Patient D’s condition, to no avail.

“We were all groping, trying to understand what was going on,” Dr. Waldmann recalled.  “In that era, one couldn’t be fatalistic, even when someone was in an apparently irreversible state. One had to assume that somehow one might be able to reverse the immunodeficiency and with that bring into control the infectious disease.”

Members of the NIH’s Metabolism Branch joined forces to study the patient’s cells in a variety of tests.  Once doctors determined that Patient D suffered from a rare case of cytomegalovirus retinitis, the National Eye Institute became involved, photographing and studying Patient D’s deteriorating eyesight.

In addition to the research, the doctors were scrambling to find a treatment that Patient D would respond to, but these treatments failed to reverse the course of the symptoms.  In fact, it would later be discovered that chemotherapy, the traditional treatment for many forms of cancer, would be ineffective for (and even harmful to) AIDS patients because of their weakened immune systems.

“At the end, the patient had massive cerebral necrosis and autolysis. We had a great number of people involved in treating all the different systems,” Dr. Waldmann said in 1990.  “His disease continued, and the patient finally died on October 28, 1981 of hypotension and respiratory failure, with multisystem involvement.”

An autopsy of the body revealed an even wider spectrum of infectious diseases, including massive necrosis, encephalitis, and degeneration of the brain.

AIDS researcher and early human immunodeficiency virus (HIV) drug developer Robert Yarchoan, M.D., recalled the gravity of the moment:

“AIDS showed us that something that no one ever worried about before suddenly could become a major problem for the country and for mankind.  And when HIV was identified as the cause of AIDS, it became apparent that, in addition to persons known to have AIDS, thousands of people in the United States were already infected with this new virus without knowing it.  Moreover, at this time, infection with HIV was in most cases fatal.”

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National Cancer Institute, “How Cancer Research Led to AIDS Breakthroughs,”

National Institutes of Health, “Dr Thomas Waldmann Oral History 1990,” interview of Dr. Waldmann on March 14, 1990 by interviewers Dennis Rodrigues, Program Analyst, and Dr. Victoria Harden, Director of the NIH Historical Office.

July 1, 1981
Doctors Identify More Cases in San Francisco & New York City

As his first day as an oncologist at San Francisco General Hospital, Dr. Paul Volberding treats his first HIV-positive patient, a 22-year-old man with Kaposi sarcoma.

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After completing a three-year fellowship at the University of California San Francisco, Dr. Volberding was ready to become a cancer specialist under renowned virologist Dr. Jay Levy.  Instead, he found himself on a lifelong journey of treating people living with HIV/AIDS and fighting the spread of the virus.

Dr. Volberding remembered his first patient with clarity.

“Twenty-two-year-old man, grew up in the Deep South, and as I recall he was estranged from his family,” Dr. Volberding told the San Francisco Examiner almost 35 years later. “He ended up in San Francisco working basically sex for food, and had innumerable previous sexually transmitted infections.”

The man died within a few months, without his family present, Dr. Volberding recalls.

Around this same time in the early summer of 1981, two doctors in the Bronx started to see HIV/AIDS symptoms in their own patients.  Dr. Gerald Friedland identified several cases of Pneumocystis pneumonia in injection drug users, and became one of the first to see the connection between IV-drug use and HIV transmission.

Pediatric immunologist Dr. Arye Rubenstein began to identify the immunodeficiency of his pediatric patients, the children of drug addicts, as a symptom of what would be eventually called AIDS.

Dr. Rubenstein, who had been seeing this particular kind of immunodeficiency in children and sometimes in their mothers in his Bronx practice since the late 1970s, was one of the first to connect pediatric cases to the new disease affecting homosexual men.

These doctors who treated some of the first known cases of HIV/AIDS went on to do important, transformative work in the fields of treatment, research and public health policy.

In 1983, Dr. Volberding established what would make San Francisco General Hospital the model for HIV care: the country’s first AIDS treatment center (Ward 86).  Later the same year, he joined the medical team at Ward 5B, the world’s first in-patient clinic for AIDS patients.

Dr. Volberding continued to treat HIV/AIDS patients until 2012, when he became director of the UCSF AIDS Research Institute.  Volberding would also become co-director of the Center for AIDS Research.

In the years to come, Dr. Friedland also dedicated his life to AIDS treatment and research.  Following 10 years of working with HIV/AIDS patients in the Bronx, Dr. Friedland became director of the HIV/AIDS Program at Yale and Professor of Medicine and Epidemiology and Public Health at Yale School of Medicine.

Dr. Friedland also became involved in HIV/AIDS international research aimed at providing access to antiretroviral therapy in developing regions of the world.  The major focus of his work became the integration of HIV and TB care and treatment in co-infected patients in South Africa.

In 2018, on the occasion of delivering the keynote address at the 13th annual International Conference on HIV Treatment and Prevention, Dr. Friedland told The Body PRO:

“Many of these people living with HIV, I have cared for, for decades.  I know them extremely well. They know me.  We have gone through this together and have this close collegial relationship as a partnership, so it’s a wondrous pleasure to continue to provide.”

The other doctor working in New York City in 1981, Dr. Rubenstein, would decide to remain in the Bronx, caring for children with HIV AIDS.  In 1983, he received a grant from the National Institutes for Health to study the incidence of AIDS in women and children. In 1986, Dr. Rubenstein established that transmission of AIDS can occur in utero, and his breakthrough findings were published in the journal Clinical Immunology and Immunopathology.

By this time, Dr. Rubsenstein had treated more than a hundred HIV-infected children, and in the summer of 1985, he opened a day care center for pediatric AIDS patients at Albert Einstein College of Medicine in the Bronx.  He became Chief of the Division of Allergy & Immunology at Children’s Hospital at Montefiore, and Professor of Pediatrics, Microbiology & Immunology at Albert Einstein College.

In a 1987 interview with New York magazine, he spoke fondly of the parents, many of them former IV-drug users, of his pediatric patients:

“Many come from a low socioeconomic group, they’re poor, the family may have broken up, they may have used drugs, and now their child has AIDS because they gave it to him.  You wouldn’t be surprised if they threw up their hands, but many don’t.  They become the best parents in the world.  They straighten out their lives, they spend hours with their kids. They give up longing for material things and look for spiritual and religious values.”

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San Francisco Examiner, “Pioneering AIDS Doctor Reflects on First Cases in SF as City Strives to Eradicate Virus,” February 8, 2015

University of California San Francisco, UCSF Profile: Paul Volberding, M.D.

The New York Times, “For Doctors, Years of Grief and Daring,” December 23, 1997

New York magazine, “Fighting AIDS” by Janice Hopkins Tanne, January 12, 1987

Yale Medicine AIDS Care Program, website

Yale University, Yale Profile: Gerald H. Friedland, M.D.

The Body Pro, “HIV ‘Providers’ Aren’t Just Doctors: An Interview with Gerald Friedland, MD” by Stephen Hicks, June 19, 2018

The New York Times, ” Ideas & Trends: The Strain of Caring for the Littlest AIDS Victims” by Jane Gross, August 4, 1985

July 2, 1981
Mention of ‘Gay Men’s Pneumonia’ Appears in Media

The Bay Area Reporter, a weekly newspaper for the gay and lesbian community in San Francisco, publishes the first mention of “Gay Men’s Pneumonia.”

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The short item advised gay men experiencing progressive shortness of breath to see their physicians.

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Bay Area Reporter, “Health Shorts: ‘Gay Men’s’ Pneumonia,” July 2, 1981

James Curran 2
CDC Creates Task Force on Kaposi’s Sarcoma & Opportunistic Infections

A Task Force on Kaposi’s Sarcoma and Opportunistic Infections is established at the Centers for Disease Control and Prevention under the direction of Dr. James Curran.

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Shortly after MMWR description of five cases of Pneumocystis carinii pneumonia (PCP) among homosexual men in Los Angeles, additional cases of other life-threatening opportunistic infections and a malignancy, Kaposi sarcoma (KS), were reported to the CDC.

Upon learning of these first cases, the CDC formed the Task Force on Kaposi’s Sarcoma and Opportunistic Infections to begin surveillance and conduct epidemiologic investigations.  Despite budget constraints at the time, about 30 CDC officers and staff were assigned to the Task Force during the summer of 1981.  CDC Director William Foege, appointed epidemiologist James Curran to lead the task force.

The Task Force first worked to establish a case definition for surveillance and investigation of the outbreak.  Previously, KS was known as an infrequently-diagnosed cancer that was rarely life-threatening, typically occurring among elderly men.  The outbreak seemed to represent a new epidemiologic form of KS.

Between June 1, 1981, and May 28, 1982, CDC would receive 355 case reports of KS and/or serious opportunistic infections, especially Pneumocystis carinii pneumonia, occurring in previously healthy persons between 15 and 60 years of age. Of the 355, 281 (79%) were homosexual (or bisexual) men, 41 (12%) were heterosexual men, 20 (6%) were men of unknown sexual orientation, and 13 (4%) were heterosexual women.

Five states — California, Florida, New Jersey, New York, and Texas — accounted for 86% of the reported cases.

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Centers for Disease Control and Prevention“AIDS: The Early Years and the CDC’s Response” by James W. Curran, M.D., and Harold W. Jaffe, M.D., October 7, 2011

Global Health Chronicles, “Interview: Jim Curran,” video posted on YouTube on June 7, 2016

Morbidity and Mortality Weekly Report | Centers for Disease Control and Prevention, “Epidemiologic Notes and Reports Update on Kaposi’s Sarcoma and Opportunistic Infections in Previously Health Persons — United States,” June 11, 1982

August 28, 1981
CDC Reports that 40% of Identified Cases Die of KS/PCP

Of the 108 known cases of Kaposi’s Sarcoma and pneumocystis carinii pneumonia, 107 are male and 94% of those whose sexual orientation is known are gay/bisexual.  About 40% of all patients have already died.

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The MMWR article, “Follow-Up on Kaposi’s Sarcoma and Pneumocystis Pneumonia,” reported that CDC received information on 70 additional cases of KS and/or PCP since its July 3 edition, making a total of 108 known cases.

News of the article alarms the gay community for its indication that the new disease is spreading and that the outcome of those infected was likely to be a quick and brutal death.

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Morbidity and Mortality Weekly Report, “Follow-Up on Kaposi’s Sarcoma and Pneumocystis Pneumonia,” August 28, 1981

September 15, 1981
Small Medical Conference is First to Address Epidemic

Fifty leading clinicians gather in Bethesda, Maryland for the first conference to address the new epidemic.

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Cosponsored by the National Cancer Institute and Centers for Disease Control and Prevention, the medical conference focused on Kaposi’s sarcoma and other opportunistic infections.  Researchers began to develop recommendations for further studies in epidemiology, virology, and treatment.

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www.HIV.gov, “A Timeline of HIV and AIDS”

National Institutes of Health, “In Their Own Words: NIH Researchers Recall the Early Years of AIDS | Timeline (1981-1988)”

September 21, 1981
First AIDS Clinic Opens in San Francisco

The Kaposi’s Sarcoma clinic at the University of California’s San Francisco Medical Center opens its doors, becoming the first clinic in the world to exclusively treat what would become to be known as AIDS.

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Overseen by Bay Area dermatologist Dr. Marcus Conant, the Kaposi’s Sarcoma clinic was also staffed by oncologist Dr. Paul Volberding, Dr. Constance Wofsy and Dr. Donald Abrams.  Collectively, the physicians guided much of the early response to AIDS in San Francisco.

Dr. Conant would go on to create the San Francisco AIDS Foundation (first called the Kaposi’s Sarcoma Research and Education Foundation) to address both the need to go into the community, which was still in denial about the disease, and the need to find non-government funding sources.

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University of California Libraries, “Marcus A. Conant Papers: 1981-1993”

American College of Physicians, “Dr. Volberding was at the Forefront of the AIDS Epidemic,” December 2017

The New York Times“Constance Wofsy, 53, Doctor Who Directed an AIDS Program,” June 9, 1996

San Francisco Chronicle, “The Good Doctor: He’s been in on the AIDS Battle Since the Beginning,” August 12, 2001

Pediatric AIDS Cases Surface in New York City

At Albert Einstein Medical College in New York, pediatric immunologist Dr. Arye Rubinstein treats five Black infants showing signs of severe immune deficiency, including pnuemocytis carinii pneumonia.

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The mothers of at least three of the children disclosed that they used drugs and/or engaged in sex work.  Dr. Rubinstein recognized that the children were showing signs of the same illnesses affecting gay men, but his diagnoses were initially dismissed by his colleagues.

“This would ultimately prove to be the moment when AIDS emerged in the Black community, driven among men, women, and children by sexual contacts, injecting drug use, and mother-to-child transmission,” writes Michael Broder in his article for Positively Aware.

By 1987, pediatric AIDS cases would be on the rise, especially in New York and especially among minority groups.  Many babies would be orphaned, creating insurmountable challenges for social workers seeking foster care placements for them.

Although medical experts estimated the number of infected infants in the city to be as many as 3,000, the City of New York has only 241 recorded cases of pediatric AIDS by the end of 1987.  Of these cases, the racial breakdown was 59% Black, 32% Hispanic and 8% White.

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Positively Aware magazine, “The Dawn of AIDS in 1981” by Michael Broder, May 30, 2021

The New York Times, “For Child With AIDS, Hospital Is Home” by Bruce Lambert, December 24, 1987

December 5, 1981
Pamphlet on KS Distributed to Conference Attendees

In an attempt to alert the medical community to the yet-unnamed disease afflicting young gay men, three dermatologists from San Francisco and New York City distribute a pamphlet on Kaposi’s sarcoma to attendees of a dermatology conference.

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Drs. Marc Conant, Alvin Friedman-Kien, and James Groundwater stationed themselves at the entrance of the annual meeting of the American Academy of Dermatology and distributed to incoming attendees a pamphlet they hastily put together about Kaposi’s sarcoma, a rare form of skin cancer that was being diagnosed in previously healthy young men in San Francisco and New York City.

Held on Dec. 5-10, the conference drew thousands of dermatologists in the United States and Canada to San Francisco to hear the latest developments in their medical field.  The pamphlet was likely the first information that most conference attendees received about Kaposi’s sarcoma (KS) and its role in the yet-unnamed disease of AIDS.

“At that point in time, not many people knew about this problem, and it wasn’t getting a whole lot of attention,” Dr. Groundwater later recalled for the San Francisco AIDS Oral History Project.  “I don’t think the seriousness of it was widely appreciated — the potential for major problems in the future.”

Dr. Groundwater said he wrote the copy for the brochure and used photographs of a patient’s KS lesions so dermatologists could see how the disease manifested.  The patient was Ken Horne, the first KS case to be reported to the Centers for Disease Control.  Horne had died on November 30, 1981, just days before the conference.

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University of California Libraries, “The San Francisco AIDS Oral History Series | The AIDS Epidemic in San Francisco: The Response of Community Physicians, 1981-1984,” interview with James R. Groundwater, M.D., conducted by Sally Smith Hughes, Ph.D. in 1996

45 percent die
December 31, 1981
45% of Patients Die by Year-End

At the close of 1981, a cumulative total of 270 cases of severe immune deficiency are reported among gay men, and 121 of those individuals have died.

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By this time, some researchers began to call the condition GRID (Gay-Related Immune Deficiency).  This terminology influences both the medical profession and the public to perceive the epidemic as limited to gay men, with serious long-term consequences for women, heterosexual men, hemophiliacs, people who inject drugs, and children.

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www.HIV.gov, “A Timeline of HIV/AIDS”

March 3, 1982
U.S. Public Health Service Hosts AIDS Conference at CDC

U.S. Public Health Service hosts a conference on AIDS at the Centers for Disease Control and Prevention in Atlanta.

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At the conference, researchers debate whether the opportunistic infections were being caused by one or more transmissible or immune-suppressing agents.

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National Institutes of Health, “Timeline (1981-1988)”

June 18, 1982
Researchers Connect AIDS Transmission to Sex

The Centers for Disease Control publishes an MMWR article that is the first to suggest sexual transmission as the source of Karposi’s sarcoma and other opportunitic infections in gay men.



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The MMWR article describes a potential sexually transmitted agent as being the link to outbreaks of KS, Pneumocystis carinii pneumonia (PCP), and other infections recently found among young gay men.

The report describes a study of 19 case subjects from June 1, 1981 to April 12, 1982 involving biopsy-confirmed KS and/or PCP among previously healthy male residents of southern California.  Following a report of possible personal connections among the KS/PCP case subjects in Los Angeles and Orange counties, interviews were conducted with the eight subjects still living and with seven of the close friends of 11 subjects who had died.

Through these interviews, the CDC was able to collect data on sexual partners for 13 of the 19 subjects. The study considered “sexual contact” to be established if the KS/PCP case subjects was reported to have “exposure” to another person that was either substantiated or not denied by the other person involved in the relationship (or by a close friend of that person).

Within five years of the onset of symptoms, nine of the KS/PCP case subjects had had sexual contact with others who had KS or PCP.  They consisisted of seven case subjects from LA County who had sexual contact with other patients from LA County, and two case subjects from Orange County had sexual contact with one patient with KS who resided outside California.

Four of the nine KS/PCP case subjects had been exposed to more than one patient who had KS or PCP. Three of the nine KS case subjects developed their symptoms after sexual contact with persons who already had symptoms of KS.  One of these three subjects developed symptoms of KS about nine months after sexual contact, another subject developed symptoms 13 months after contact, and a third subject developed symptoms 22 months after contact.

The other four KS/PCP case subjects in the group of 13 had no known sexual contact with reported cases. However, one KS case subject had an apparently healthy sexual partner in common with two persons with PCP; one KS case subject reported having had sexual contact with two friends of the non-Californian with KS; and two PCP case subjects had most of their anonymous contacts (greater than or equal to 80%) with persons in bathhouses.

The editorial note to the report included these points:

  • An estimated 185,000-415,000 homosexual males lived in LA County in 1982.
  • If one assumes each homosexual male in LA County has between 13 and 50 different sexual partners per year during 1977-1982, “the probability that seven of 11 patients with KS or PCP would have sexual contact with any one of the other 16 reported patients in LA County would seem to be remote.”
  • With this same assumption, “the probability that two patients with KS living in different parts of Orange County would have sexual contact with the same non-Californian with KS would appear to be even lower.”
  • Thus, observations in LA and Orange counties imply the existence of an unexpected cluster of cases.

The CDC then puts forth the hypothesis that infectious agents are being sexually transmitted among homosexually active males.

“Infectious agents not yet identified may cause the acquired cellular immunodeficiency that appears to underlie KS and/or PCP among homosexual males. If infectious agents cause these illnesses, sexual partners of patients may be at increased risk of developing KS and/or PCP,” the CDC report posits.

The CDC proposes another hypothesis:  “Sexual contact with patients with KS or PCP does not lead directly to acquired cellular immunodeficiency, but simply indicates a certain style of life. The number of homosexually active males who share this lifestyle may be much smaller than the number of homosexual males in the general population.”

The CDC goes on to suggest the possibility of exposure to “some substance (rather than an infectious agent)” leading to immunodeficiency among homosexual males that share a particular style of life.

The report cites a New York City-based report suggesting a connection between amyl nitrite (commonly referred to as “poppers”) and an increased risk of KS.  This hypothesis would later be scientifically disproved.

* * * * *

Mortality and Morbity Weekly Report, “A Cluster of Kaposi’s Sarcoma and Pneumocystis carinii Pneumonia among Homosexual Male Residents of Los Angeles and range Counties, California,” June 18, 1982

July 16, 1982
CDC Identifies Hemophilia-AIDS Connection

CDC reports three cases of hemophiliacs diagnosed with pneumocystis carinii pneumonia, a common AIDS-related illness.

Learn More.

The CDC’s MMWR article is the first report of the AIDS-related condition of immunosuppression in patients with hemophilia who have no other known risk factors for AIDS.

By the time the MMWR article is published, two of the three subjects have died.

* * * * * *

Mortality and Morbidity Weekly Report, “Epidemiologic Notes and Reports Pneumocystis carinii Pneumonia among Persons with Hemophilia A,” July 16, 1982

September 24, 1982
CDC Introduces the Term ‘AIDS’

In a report to the medical community, the Centers for Disease Control and Prevention coins the term “AIDS” — Acquired Immune Deficiency Syndrome.

Learn More.

The MMWR article also includes the first case definition for AIDS: “A disease at least moderately predictive of a defect in cell-mediated immunity, occurring in a person with no known cause for diminished resistance to that disease.”

Today, AIDS is defined as a set of symptoms (or syndrome) caused by the HIV virus. A person is said to have AIDS when their immune system is too weak to fight off infection. This is the last stage of HIV, when the infection is very advanced.

* * * * * *

Mortality and Morbidity Weekly Report | Centers for Disease Control and Prevention, September 24, 1982

November 5, 1982
AIDS Precautions Created for Medical Personnel

The Centers for Disease Control and Prevention lays out the first set of precautions for clinical and lab staff working with people with AIDS symptoms.

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CDC’s report, “Current Trends Acquired Immune Deficiency Syndrome (AIDS): Precautions for Clinical and Laboratory Staffs,” introduced precautions for medical personnel working with people exhibiting signs of AIDS.

The report noted that “airborne spread and interpersonal spread through casual contact do not seem likely.”

Those providing care to people with AIDS were advised the following:

    1. Extraordinary care must be taken to avoid accidental wounds from sharp instruments contaminated with potentially infectious material and to avoid contact of open skin lesions with material from AIDS patients.
    2. Gloves should be worn when handling blood specimens, blood-soiled items, body fluids, excretions, and secretions, as well as surfaces, materials, and objects exposed to them.
    3. Gowns should be worn when clothing may be soiled with body fluids, blood, secretions, or excretions.
    4. Hands should be washed after removing gowns and gloves and before leaving the rooms of known or suspected AIDS patients. Hands should also be washed thoroughly and immediately if they become contaminated with blood.
    5. Blood and other specimens should be labeled prominently with a special warning, such as “Blood Precautions” or “AIDS Precautions.” If the outside of the specimen container is visibly contaminated with blood, it should be cleaned with a disinfectant (such as a 1:10 dilution of 5.25% sodium hypochlorite (household bleach) with water). All blood specimens should be placed in a second container, such as an impervious bag, for transport. The container or bag should be examined carefully for leaks or cracks.
    6. Blood spills should be cleaned up promptly with a disinfectant solution, such as sodium hypochlorite (see above).
    7. Articles soiled with blood should be placed in an impervious bag prominently labeled “AIDS Precautions” or “Blood Precautions” before being sent for reprocessing or disposal. Alternatively, such contaminated items may be placed in plastic bags of a particular color designated solely for disposal of infectious wastes by the hospital. Disposable items should be incinerated or disposed of in accord with the hospital’s policies for disposal of infectious wastes. Reusable items should be reprocessed in accord with hospital policies for hepatitis B virus-contaminated items. Lensed instruments should be sterilized after use on AIDS patients.
    8. Needles should not be bent after use, but should be promptly placed in a puncture-resistant container used solely for such disposal. Needles should not be reinserted into their original sheaths before being discarded into the container, since this is a common cause of needle injury.
    9. Disposable syringes and needles are preferred. Only needle-locking syringes or one-piece needle-syringe units should be used to aspirate fluids from patients, so that collected fluid can be safely discharged through the needle, if desired. If reusable syringes are employed, they should be decontaminated before reprocessing.
    10. A private room is indicated for patients who are too ill to use good hygiene, such as those with profuse diarrhea, fecal incontinence, or altered behavior secondary to central nervous system infections. Precautions appropriate for particular infections that concurrently occur in AIDS patients should be added to the above, if needed.

* * * * *

Mortality and Morbidity Weekly Report, “Current Trends Acquired Immune Deficiency Syndrome (AIDS): Precautions for Clinical and Laboratory Staffs,” November 4, 1982

Ward 86
January 1, 1983
Ward 86: First Dedicated AIDS Outpatient Clinic Opens

Ward 86, the worlds first dedicted AIDS outpatient clinic, opens at San Francisco General Hospital, a partnership with the University of California San Francisco.  The clinic becomes the gold standard for treating patients living with HIV/AIDS .

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Ward 86 drew staff who were passionate about treating people with AIDS.  Over time, the clinic team developed the San Francisco Model of Care, which focused on treating patients with compassion and respect; providing an array of health and social services in one facility; and collaborating closely with the local health department and community organizations.

Founded by AIDS pioneers Drs. Paul Volberding, Donald Abrams and Constance Wofsy, the clinic would see thousands of patients annually, ranging in age from 18 to 82, in the coming years.

In June 1983, the inpatient HIV unit, 5B, would also open at San Francisco General Hospital.

* * * * *

University of California San Francisco, “SFGH’s Ward 86: Pioneering HIV/AIDS Care for 30 Years” by Tristan Cook, June 7, 2011

Bay Area Reporter, “Hospital’s HIV/AIDS Division Marks 25th Anniversary” by Seth Hemmelgarn, November 27, 2008

San Francisco Chronicle, “SF AIDS Ward 86 – 25 Years of Saving Lives” by Elizabeth Fernandez, December 1, 2008

January 4, 1983
CDC Shares Data on AIDS & Hemophilia with Red Cross

The Public Health Service hosts a meeting convened by the CDC and attended by 200 members of the blood services community to address opportunistic infections in hemophiliacs.  At the meeting, the Red Cross and other blood supply organizations receive preliminary data on the indication of the AIDS virus within the blood supply.

Learn More.

At the conference, scientists from the CDC recommended that blood banks begin implementing donor screening measures, such as questioning donors about risk behaviors and running blood donations through a series of tests.  Faced with daunting data and the same uncertainties, the blood banks and the plasma companies came away from the conference with different plans..

Playing down the extent of the risk, leaders of the blood banks would decide that the CDC’s evidence did not show conclusively that HIV was a blood-borne disease, and they would decline to screen out potentially infected donors.  The blood bank physicians questioned the validity of the CDC data, which correlated of anti-HBc to AIDS cases among a cohort of homosexuals who attended an STD clinic.

By contrast, the plasma companies concurred with the CDC that there was a good chance HIV was being transmitted by their products.  They moved very quickly to switch the source of their supply and introduced new methods to inactivate viruses in plasma derivatives.  However, they also decided to keep older product batches on the market, and commercial plasma ended up infecting more people than did donated blood.

Getting blood or plasma out of one person and safely into another is a complex process.  Blood banks, such as the Red Cross, obtain almost all of their supply from voluntary donors.  They process and then distribute freely donated blood to hospitals, which they charge for their services.

Every year, about 14 million units of blood are donated in the U.S.  The American Red Cross collects about 45% of the total, blood banks about 42%, hospitals 11%, and the small remainder is imported.  About 3.6 million people receive transfusions of these products every year.

In the 1970s, blood collection and transfusion had a number of risks associated with it, in particular the prevalence of hepatitis in the supply.  In late 1982, when evidence began to show that a new disease might be spreading through blood products, things became more complicated.

The blood bank scientists accepted that HIV/AIDS appeared to be a threat to the blood supply, but found it difficult to measure the risk.  U.S. surveillance systems were ill-equipped to identify diseases with a long incubation period such as AIDS.

* * * * * *

National Institutes of Health | National Library of Medicine, “HIV And The Blood Supply: An Analysis Of Crisis Decisionmaking” (National Academies Press, 1995)

The Emergence of HIV in the U.S. Blood Supply: Organizations, Obligations, and the Management of Uncertainty by Kieran Healy (Kluwer Academic Publishers, 1999)

January 7, 1983
Women Included in AIDS Case Studies

The CDC publishes its first article that includes women among those diagnosed with AIDS.



Learn More.

“Epidemiologic Notes and Reports Immunodeficiency among Female Sexual Partners of Males with Acquired Immune Deficiency Syndrome (AIDS) — New York” includes the first cases of AIDS in women participating in a research study.

The MMWR article described the cases of two women who were sexual partners of men diagnosed with AIDS.

In one case, a 37-year-old Black woman began losing weight in June 1982 and had developed oral candidiasis and swollen lymph nodes a month later.  Tests revealed she had Pneumocystis carinii pneumonia (PCP), as well as lymphopenia and a depletion of T-helper cells.  She said she was not an intravenous drug user, but her sexual partner since 1976 had a history of IV drug abuse.  The woman’s partner died of AIDS in November 1982.

In the second case included in the report, a 23-year-old Hispanic woman developed swollen lymph nodes in early 1982.  Tests showed she had elevated immunoglobulin levels, lymphopenia, decreased T-helper cell numbers, and a depressed T-helper/T-suppressor cell ratio.  She had no previous illnesses or therapy associated with immunosuppression.  Since the summer of 1981, her only sexual partner was a bisexual male who had developed AIDS-related symptoms in 1981.

* * * * * *

Mortality and Morbidity Weekly Report, “Epidemiologic Notes and Reports Immunodeficiency among Female Sexual Partners of Males with Acquired Immune Deficiency Syndrome (AIDS) — New York,” January 7, 1983

HIV and the Blood Supply
January 26, 1983
Opposing Views in CDC & Red Cross Lead to Blood Screening Delays

Following a meeting hosted by the Centers for Disease Control and Prevention on opportunistic infections in hemophiliacs, an American Red Cross interoffice memo is released that indicates strong opposition to a widespread screening of blood supply products.

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An American Red Cross interoffice memo blasts the CDC after its January 4 meeting, stating, “CDC is likely to continue to play up AIDS.”

The memo goes on to say;  “It has long been noted that CDC increasingly needs a major epidemic to justify its existence.  To the extent the [blood supply] industry sticks together against CDC, it will appear to some segments of the public at least that we have a self interest which is in conflict with the public interest, unless we can clearly demonstrate that CDC is wrong.”

Donor screening issues arose in mid to late 1982, when cases of AIDS in hemophiliacs were first reported, including the first transfusion-associated AIDS case in an infant.

Between December 1982 and December 1983, there were two critical events that presented opportunities for the blood services community to enact new donor screening and deferral policies to reduce the threat of HIV transmission through blood and blood products.

The first, which occured on January 4, 1983, was at the Public Health Service meeting convened by the CDC.  This meeting was widely publicized, and over 200 people attended, including representatives of the FDA, NIH, the National Hemophilia Foundation, the National Gay Task Force, blood banks, and the plasma fractionation industry.

This was where the blood services community first received data on the possibility of a transmissible agent within its blood supply.  CDC scientists recommended that blood banks implement specific donor screening measures (such as questioning donors about their risk behaviors and running blood donations through a series of tests).

Some participants in the Atlanta meeting and others in key decision-making roles expressed reservations about the validity of the CDC data and indicated that they did not believe the CDC to be a credible source of information regarding AIDS.  Following the conference, American Red Cross officials would encourage colleagues to resist recommendations from the CDC.

The ensuing resistance by blood banks to implementing the CDC’s donor screening measures is now viewed as a critical failure on their part in the effort to limit transmission of HIV early on in the epidemtic.

The second critical event would occur in December 15-16, 1983, when the Blood Products Advisory Committee of the FDA would convene a meeting to discuss all possible options of surrogate marker tests for HIV.  This meeting is notable for being the CDC’s second attempt to address the need to implement blood screening as a means to implement safeguards to the blood supply.

In the year between the two meetings, blood banks would continue to collect donations from unscreened members of the public.

* * * * * *

HIV And The Blood Supply: An Analysis Of Crisis Decisionmaking by the U.S. Institute of Medicine  Committee to Study HIV Transmission Through Blood and Blood Products (National Academies Press, 1995)

March 4, 1983
CDC Issues Recommendations on AIDS Prevention

CDC issues recommendations for preventing the transmission of AIDS.  The report states that most AIDS cases are found among gay men with multiple sex partners, intravenous drug users, receipients of blood transfusions, and Haitians.

Learn More.

The report “Current Trends Prevention of Acquired Immune Deficiency Syndrome (AIDS): Report of Inter-Agency Recommendations” is also notable in that it is the first to suggest that AIDS may be caused by an infectious agent that is transmitted sexually or through exposure to blood or blood products.

* * * * * *

Mortality and Morbidity Weekly Report, “Current Trends Prevention of Acquired Immune Deficiency Syndrome (AIDS): Report of Inter-Agency Recommendations,” March 4, 1983

Francoise Barre Sinoussi
French Researcher Discovers Virus that Causes AIDS

French researchers Francoise Barre-Sinoussi and Jean-Claude Chermann identify the virus that “might be” responsible for AIDS, calling it “LAV” (lymphadenopathy associated virus).

Learn More.

The following year, U.S. researcher Robert Gallo announced he had found the “probable” cause of AIDS, the retrovirus HTLV-III.  The two viruses — HTLV-III and LAV — turned out to be one and the same, and in May 1986 it became officially known as the human immuno-deficiency virus, or HIV.

Barre-Sinoussi made her discovery while under French virologist Luc Montagnier, and both would go on to win the 2008 Nobel Prize in Physiology or Medicine for identifying the AIDS virus.  Barre-Sinoussi’s discovery ultimately led to the development of anti retroviral medications that have turned AIDS from a death sentence to a manageable chronic disease.

Barré-Sinoussi dedicated her career as a scientist and as an activist to halting the spread of AIDS.  Being on the front lines of the AIDS devastation was, she admitted, “very tough psychologically.”

The pressure was so intense that, once antiretroviral therapy was discovered in 1996, Barré-Sinoussi fell into a depression, and pulled back from her public commitments. But she soon returned to the fight, often travelling around the world to meet with political leaders and healthcare providers seeking solutions to local epidemics.

“Like everybody, I have some times in my life when I’m pessimistic,” she said.  “I wonder whether I should continue … Then I go and have a trip to Africa or Southeast Asia and have a small meeting with people affected by HIV, and I forget my mood. I say, ‘OK, let’s go on. Let’s continue. This is real life. Don’t think about yourself.'”

She currently directs the Regulation of Retroviral Infections Unit at the Pasteur Institute, which is still looking for a vaccine or a functional cure.

* * * * * *

The Nobel Prize, “Women Who Changed Science: Francoise Barré-Sinoussi”

CNN, “HIV discovery ‘will change your life forever’” by Jen Christensen, June 4, 2013

Nature magazine, “The discovery of HIV-1” by Sonja Schmid, November 28, 2018

PBS News Hour, “How the Discovery of HIV Led to a TransAtlantic Research War” by Dr. Howard Markel, March 24, 2020

Pastuer Institute | The Research Journal, “Françoise Barré-Sinoussi and Her Research on the HIV-1 VIrus,” July 17, 2018

Fauci at NIH
June 23, 1983
NIH Researchers Share AIDS Data & Theories

Researchers from the National Institutes of Health convene at the Clinical Center in Bethesda, Maryland to receive an update on AIDS, led by Anthony Fauci, M.D.

Learn More.

Then the director of the National Institute of Allergy and Infectious Diseases, Dr. Fauci led a presentation that summarized what was currently known about AIDS.

The presentation’s corresponding paper was co-authored by Dr. Fauci with Abe Macher, M.D.; Dan Longo, M.D.; H. Clifford Lane, M.D.; Alain Rook, M.D.; Henry Masur, M.D.; and Edward P. Gelmann, M.D.  Among the conclusions the researchers made were:

– The cause AIDS was unknown but likely due to “a transmissible agent, most likely a virus.”

– AIDS was spread “by sexual contact, particularly homosexual activity.”

– Blood-borne transmission was “the other major recognized form of spread of the disease.”

– It was “highly likely” that the disease could not readily spread through casual, nonsexual, non-blood-borne routes.

The paper considers the possibility that the disease may kill all who are infected with it, and calls it “one of the most extraordinary transmissible diseases in history.”

* * * * * *

Annals of Internal Medicine | American College of Physicians, “Acquired Immunodeficiency Syndrome: Epidemiologic, Clinical, Immunologic, and Therapeutic Considerations” by Anthony S. Fauci, M.D., Abe M. Macher, M.D., Dan L. Longo, M.D., H. Clifford Lane, M.D., Alain H. Rook, M.D., Henry Masur, M.D., Edward P. Gelmann, M.D., January 1, 1984

July 25, 1983
Ward 5B: Inpatient AIDS Ward Opens in San Francisco

San Francisco General Hospital opens Ward 5B, the first dedicated inpatient AIDS ward in the U.S.  The ward consists of all-volunteer caregivers and staff.

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Ward 5B is the answer to a petition organized by psychiatric nurse Cliff Morrison, demanding compassionate, holistic care for AIDS patients in San Francisco.  By August, the ward’s 12 beds are fully occupied.

Run by Morrison and an all-volunteer team, Ward 5B allowed patients to create their own family made up of friends and partners. The nurses recognized that many of the patients were isolated from their families or had long-term, though not legal, partners.

The ward was one of the first units in the country that allowed visitors at any time.

* * * * * *

August 1, 1983
UCLA Researchers Push for Discovery of AIDS Cause

At a UCLA medical conference, Los Angeles researchers urge the scientific community to focus their work on identifying the cause of “acquired immunodeficiency syndrome.”

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In a presentation to the conference led by Michael S. Gottlieb, M.D., the UCLA researchers highlighted critical issues surrounding new disease, including diagnosis methodology, screening of blood products, and treatment of opportunistic infections and cancers related to the illness.  They emphasized that the prognosis for recovery in affected persons was dire, as there still was no effective treatment once the illness took hold.
Co-authoring the presentation with Dr. Gottlieb were Jerome E. Groopman, M.D.; Wilfred M. Weinstein, M.D.; John L. Fahey, M.D.; and Roger Detels, M.D.* * * * * *

AIDS Memorandum
‘AIDS Memorandum’ Created for Research-Sharing

The National Institute of Allergy and Infectious Diseases begins publishing an informal newsletter, the AIDS Memorandum, through which scientists can share unpublished research findings.

Learn More.

The publication lasts for two years, until mainstream scientific journals begin expediting publication for articles on AIDS.

* * * * * *

September 2, 1983
AIDS Exposure Precautions Issued to Healthcare Workers

CDC publishes the first set of AIDS exposure precautions for healthcare workers.

Learn More.

In response to growing concerns about the potential for AIDS transmission in healthcare settings, CDC publishes occupational exposure precautions for healthcare workers and allied health professionals.

* * * * * *

September 9, 1983
CDC Rules Out AIDS Transmission by Casual Contact

In an MMWR article read around the world, CDC rules out transmission of AIDS by casual contact, food, water, air, or environmental surfaces.

Learn More.

In the CDC Report “Current Trends Update: Acquired Immunodeficiency Syndrome (AIDS) — United States,” CDC identifies all major routes of HIV transmission — and rules out transmission by casual contact.

* * * * * *

September 12, 1983
NIH Sponsors ‘Workshop on Epidemiology of AIDS’

The National Institute of Health hosts “A Workshop on the Epidemiology of AIDS” at the Holiday Inn Crowne Plaza in Rockville, Maryland.

Learn More.

At the workshop, researchers collaborated to develop recommendations for research on the epidemiology and natural history of AIDS, and exchange information and educate clinical investigators about epidemio logical study design.

Held over two days, the workshop featured several panel discussions and lectures, including “Summary of Epidemiological Research on AIDS Supported by the NIH” by Robert Edelman, MD, Clinical Professor of Medicine and Pediatrics, University of Maryland School of Medicine.

* * * * * *

Pediatric AIDS Cases Presented to NY Academy of Science, and Rejected

Dr. Arthur J. Ammann presented case reports of immunodeficiency in infants as evidence of AIDS infecting children — but the medical community largely refused to accept the idea that a disease spread among gay men was being found in babies.

Learn More.

Dr. Ammann travelled from San Francisco to New York City for an immunolgy conference hosted by the New York Academy of Science to report on his research on pediatric AIDS patients.  He announced that he had identified two new means of transmission of the virus, in utero mother-to-infant and blood transfusions.

Conference attendees responded to Dr. Ammann’s presentation with indifference and rejection.  Included in the nay-sayers was even his old mentor, Robert A. Good, M.D., who had served as president of the American Association of Immunologists and more recently as director of the Sloan-Kettering Institute for Cancer Research.

“Bob Good got up and said that he didn’t think that we were seeing AIDS in children, that he had seen this immunodeficiency with CMV [cytomegalovirus virus] before,” Dr. Ammann recalled for the San Francisco AIDS Oral History Series.  “I quickly responded, because I had looked up all the literature. I said, ‘If it’s been seen before, no one’s ever reported it.'”

Dr. Ammann said he had just met with Arye Rubinstein, M.D., another immunologist working with pediatric AIDS patients, who told him that he was receiving the same immediate resistance to his own case reports.

“People just didn’t want AIDS to affect infants,” said Dr. Ammann.  “They just didn’t believe it.  And they didn’t believe it until HIV testing became available.”

As the lead pediatric AIDS practitioners on the West Coast and East Coast, respectively, Drs. Ammann and Rubinstein did not let the initial rejection from the medical community deter them from their work.

Through 1985, Dr. Ammann would continue to serve as director of Pediatric Immunology and Clinical Research Center at University of California San Francisco.  In 1988, he would join the Board of Directors for the American Foundation for AIDS Research (AmFAR), where he would serve as president in 1997-1998.  In 1997, Dr. Ammann would found Global Strategies for HIV Prevention to address the inequity of HIV prevention services provided around the world.

In a 1988 article for The San Francisco Chronicle, Dr. Ammann would draw nationwide attention to the issue of pediatric AIDS when he predicts that at least 20,000 children will contract AIDS in the next four years.  Sadly, his prediction would be borne out.  By 1992, about 5,000 cases of pediatric AIDS would be reported to the CDC, with the actual number of HIV-infected children to be estimated at about 20,000.

In 2017, Dr. Ammann would publish a first-person account of the pediatric HIV/AIDS crisis, Lethal Decisions: The Unnecessary Deaths of Women and Children from HIV AIDS.  Dr. Ammann would die four years later, in San Rafael, California on August 15, 2021, at the age of 85.

Dr. Arye Rubinstein would also dedicate his life to the care of children and women with HIV.

The National Institutes for Health would award a grant to Dr. Rubinstein for the study of AIDs in women and children, the first to focus specifically on that population. In 1986, he established that transmission of AIDS can occur in utero, and he published his finding in the journal Clinical Immunology and Immunopathology.

By 1985, Dr. Rubinstein would estimate that he had treated about 100 children with the virus at his practice based out of Albert Einstein College of Medicine in the Bronx.

At the time, New York public health policy dictated that pediatric AIDS patients be confined to hospitals, so misunderstood was the nature of the virus.  So Dr. Rubinstein decided to open a day care center at Albert Einstein College of Medicine for the families of pediatric AIDS patients, and successfully petitioned the City of New York for the funds to build it.

He would take personal risks to come to the defence of his pediatric patients’ parents, many of whom had a history of drug use and sex work, and were not equipped to navigate the backlash of fear and anger directed at them.

“I was almost assaulted after testifying in court in Brooklyn,” recalled Dr. Rubinstein in an 2011 edition of Einstein Magazine. “The parents in one school wanted to remove children who were infected, but I testified that HIV was not transmitted through casual contact.  The parents got very upset, to the point where I had to be hauled out of the courtroom through a back door.”

In 1986, Dr. Rubinstein and colleagues would show that IV gamma globulin helps prevent infections and T-cell attrition in children with AIDS, significantly improving survival rates.  Later the same year, he would demonstrate that in pregnant women with HIV, transmission of the virus often occurs in utero and not just at delivery or through breast-feeding.

In the April 1987 edition of Pediatric Research, he would co-author a paper about the increase in AIDS cases of women whose only known risk factor was heterosexual contact with HIV positive men.  In another pediatric publication, he would report that the leading cause of death in 1987 for women between the ages of 24 and 35 was AIDS.

In 1989, Dr. Rubinstein would launch a summer camp in the Catskills for children with HIV and
their families (many more similar camps would open in the 1990s).   He currently is chief of the Division of Allergy & Immunology at Children’s Hospital in Montefiore and Professor of Pediatrics at Albert Einstein College of Medicine.

November 22, 1983
WHO Brings Global Eye to Pandemic

The World Health Organization holds its first meeting to assess global AIDS situation, beginning international surveillance of the disease.

December 15, 1983
FDA Hosts Conference to Consider Protections of Blood Supply

The CDC and FDA would convene a meeting of blood services organizations to discuss screening options for HIV/AIDS.  This is the CDC’s second attempt to address the need for blood screening as a means to safeguard to the country’s blood supply.

Learn More.

At the December 15-16 meeting, the FDA’s Blood Products Advisory Committee facilitates a discussion of the options for HIV surrogate marker tests.  This conference is a follow-up to the one held in January 1983, where blood bank scientists remained unmotivated to begin blood screening.

After the January meeting, an American Red Cross interoffice memo stated, “CDC is likely to continue to play up AIDS.  It has long been noted that CDC increasingly needs a major epidemic to justify its existence.”

In the year between the two meetings, blood banks would continue to collect donations from unscreened members of the public.  The initial resistance by blood banks to implement the CDC’s donor screening measures is now viewed as a critical failure on their part in the effort to limit transmission of HIV early on in the epidemtic.

At the December 1983 meeting, industry representatives proposed the creation of a task force to deliberate the details of a recommendation made at the meeting by Dr. Dennis Donohue, director of the FDA’s Division of Blood and Blood Products.  Dr. Donohue proposed that hepatitis B anti-core testing be incorporated for routine plasma screening, since it would identify 90% of all potentially infectious or high-risk donors.

While Dr. Donohue was not enthusiastic about the task force approach, which was generally seen as the industry’s way to delay screening requirements, he agreed to it.

Gallo ids virus
April 23, 1984
Dr. Robert Gallo Identifies Retrovirus as Cause of AIDS

U.S. Department of Health & Human Services Secretary Margaret Heckler announces that Dr. Robert Gallo and his colleagues at the National Cancer Institute have found the cause of AIDS, a retrovirus they have labeled HTLV-3.

Learn More.

Heckler also announces the development of a diagnostic blood test to identify HTLV-3 and expresses hope that a vaccine against AIDS will be produced within two years.

Dr. Gallo and his research colleagues developed a process to mass-produce the retrovirus for the purpose of developing the tools needed to identify, treat and cure the disease that has afflicted more than 4,000 Americans to date.

The announcement follows the announcement by the Pasteur Institute in Paris of its discovery of LAV, which they say causes AIDS.

Heckler said she thought the two viruses ”will prove to be the same.”

July 13, 1984
CDC Cites IV Drug Use & Needle Sharing as AIDS Transmitter

U.S. Centers for Disease Control pubishes research demonstrating that avoiding injection drug use and reducing needle-sharing would help prevent the spread of HIV/AIDS.

November 24, 1984
Fauci: Spread of AIDS is Accelerating

The spread of AIDS worldwide is accelerating, researcher Anthony Fauci, M.D., tells clinical staff gathered at an internal conference at the National Institutes of Health.

Learn More.

Dr. Fauci, who previously reported that the disease struck primarily gay men, tells his colleagues: “There is increasing evidence, particularly from Zaire, that the virus can be spread by heterosexual contact.”

Dr. Fauci’s presentation is accompanied by a paper co-authored with Henry Masur, M.D.; Edward Gelmann, M.D.; Phillip Markham, Ph.D.; Beatrice Hahn, M.D.; and H. Clifford Land, M.D.

In the paper, the scientists summarize the results of their research into the treatment of opportunistic infections.

“Attempts at immune reconstitution with lymphocytes and lymphokines have resulted in some transient improvement in immune function but without clinical effect, indicating the need for specific antiretroviral therapy in combination with immune reconstitution,” the paper states.

January 11, 1985
CDC Updates AIDS Definition & Issues Guidelines for Blood Screening

The U.S. Centers for Disease Control (CDC) revises the AIDS case definition to note that AIDS is caused by a newly identified virus. CDC also issues provisional guidelines for blood screening.

Learn More.

The report includes the following “recommendations for the individual” judged most likely to have an HTLV-III infection:

1. The prognosis for an individual infected with HTLV-III over the long term is not known.
However, data available from studies conducted among homosexual men indicate
that most persons will remain infected.
2. Although asymptomatic, these individuals may transmit HTLV-III to others. Regular
medical evaluation and follow-up is advised, especially for individuals who develop
signs or symptoms suggestive of AIDS.
3. Refrain from donating blood, plasma, body organs, other tissue, or sperm.
4. There is a risk of infecting others by sexual intercourse, sharing of needles, and possi­
bly, exposure of others to saliva through oral-genital contact or intimate kissing. The efficacy of condoms in preventing infection with HTLV-III is unproven, but the consis­
tent use of them may reduce transmission.
5. Toothbrushes, razors, or other implements that could become contaminated with
blood should not be shared.
6. Women with a seropositive test, or women whose sexual partner is seropositive, are
themselves at increased risk of acquiring AIDS. If they become pregnant, their offspr­
ing are also at increased risk of acquiring AIDS.
7. After accidents resulting in bleeding, contaminated surfaces should be cleaned with
household bleach freshly diluted 1:10 in water.
8. Devices that have punctured the skin, such as hypodermic and acupuncture needles,
should be steam sterilized by autoclave before reuse or safely discarded. Whenever
possible, disposable needles and equipment should be used.
9. When seeking medical or dental care for intercurrent illness, these persons should
inform those responsible for their care of their positive antibody status so that ap­
propriate evaluation can be undertaken and precautions taken to prevent transmission
to others.
10. Testing for HTLV-III antibody should be offered to persons who may have been infect­
ed as a result of their contact with seropositive individuals (e.g., sexual partners, per­
sons with whom needles have been shared, infants born to seropositive mothers).
March 2, 1985
Blood Test for HIV Becomes Available

The U.S Food and Drug Administration licenses the first commercial blood test, ELISA, to detect HIV. Blood banks begin screening the U.S. blood supply.

Learn More.

A positive result on ELISA (an enzyme-linked immunosorbent assay) must be confirmed by a second test for a person to receive a definitive diagnosis of HIV infection.

Today, many single-test options are available to test for HIV (Human Immunodeficiency Virus), including an FDA-approved, at-home test called OraQuick.  Approved in 2012 for sale to anyone age 17 and older, the OraQuick In-Home HIV Test tests fluid from the mouth and delivers results in 20 to 40 minutes.  The kit does not require sending a sample to a lab.

HIV screening is covered in the U.S. by health insurance without a co-pay, as required by the Affordable Care Act.  Some testing sites offer free tests for those without medical insurance coverage.

The FDA still regulates the tests that detect infection with HIV.  An estimated 1.1 million people in the U.S. are living with HIV, and about one in seven don’t know they have it, according to the CDC.

The CDC recommends that everyone between the ages of 13 and 64 years old be screened for HIV at least once as part of their routine health care. More frequent testing is recommended for people who have a higher risk of infection because of behaviors such as having sex without condoms, having sex with multiple partners, or injecting drugs using shared needles.

April 5, 1985
Atlanta Hosts International AIDS Conference

The U.S. Department of Health and Human Services and the World Health Organization  host the first International AIDS Conference  in Atlanta, Georgia on April 15-17.

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More than 2,000 researchers gathered at the conference to share information and assess prospects for controlling the disease, not yet realizing that the worst was yet to come.

The Atlanta conference featured 392 presentations and generated considerable excitement among participants eager to learn about how this new disease was playing out within specific populations in the U.S.

Much of the news was discouraging, however, as presenters introduced new data that showed that many of those dying in 1985 had been infected before 1981, and that within especially vulnerable populations, the epidemic was becoming entrenched.

At a side meeting before the day the conference opened, gay activists protested Reagan administration proposals to implement mandatory HIV testing policies, arguing that this would do little to halt the spread of the disease and would only intensify discrimination against vulnerable groups.

April 10, 1985
Haitians Removed from CDC’s High-Risk List

CDC removes Haitians from the list of those at increased risk for AIDS, because scientists can no longer justify including them on statistical grounds,

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The CDC, which began investigating the mysterious and often-fatal disease in 1981, initially identified Haitian immigrants, intravenous drug users, hemophiliacs, and homosexual or bisexual men as groups at high risk for HIV/AIDS.

The CDC’s weekly reports of AIDS statistics included all four groups, but starting in April 1985, Haitians were no longer included as a separate listing.

The April 1985 report cited a total of 9,405 cases of AIDS reported in the U.S.  Of those cases, 285 (about 3%) were Haitians, said Dr. Walter Dowdle, director of the Center for Infectious Diseases. Previously the rate for Haitians had been as high as 5%. By contrast, about 75% of the cases were of males who identified as homosexual or bisexual.

”The Haitians were the only risk group that were identified because of who they were, rather than what they did,” he said.

December 6, 1985
CDC Issues Precautions to Prevent Mother-to-Infant Transmission

CDC issues recommendations on preventing mother-to-child transmission of HIV.   It is believed that HIV is transmitted from infected women to their fetuses during pregnancy, or to their infants shortly after birth.

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The CDC’s Morbidity and Mortality Weekly Report recommends that HIV-infected women delay pregnancy until more is known about the risks of transmission, and advised new mothers to avoid breastfeeding.

Transmission of the virus during pregnancy or labor and delivery is demonstrated by two reported AIDS cases occurring in children who had no contact with their infected mothers after birth.

With studies on the subject of pediatric AIDS is just beginning, the rate of perinatal transmission of HIV from infected pregnant women is unknown and the limited amount of available data suggests a high rate.

However, the report contends that perinatal transmission (from an infected mother to her newborn) is not inevitable.

Of three children born to women who became infected with HIV by artificial insemination from an infected donor, all were in good health and negative for antibody to the virus more than 1 year after birth.  Another child, born to a woman living with AIDS, was HIV-negative and healthy at birth and at 4 months of age.

In December 1985, a total of 217 cases of AIDS have been reported among children under age 13, and 60% of them have died.

January 16, 1986
Virus Spread Grows at Increasing Rate in U.S.

More people were diagnosed with AIDS in 1985 than in all earlier years combined, according to the CDC.  Public health experts predict twice as many new AIDS cases in the next year.

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The CDC report states that, on average, people diagnosed with AIDS die about 15 months after the disease is diagnosed.  The report also shows:

  • Between 6/1/1981 and 1/13/1986, there have been 16,458 cases of AIDS (16,227 adults and 231 children) reported in the U.S.  Of these, more than half of the infected people have died.
  • The number of cases reported each 6-month period continues to increase.
  • Cases have been reported from all 50 states, the District of Columbia, and three U.S. territories.

“One million Americans have already been infected with the virus, and this number will jump to at least 2 million or 3 million within 5 to 10 years,” National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony Fauci tells The New York Times.

May 1, 1986
AIDS Virus Officially Called ‘HIV’

The International Committee on the Taxonomy of Viruses announces that the virus that causes AIDS will officially be known as “Human Immunodeficiency Virus ” (HIV).

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An international committee of scientists is proposing that the AIDS virus be called by a new name: human immunodeficiency virus, or HIV.

Until now, the closely related variations of the virus have been most frequently referred to as HTLV-3, for human t- cell lymphotropic virus type 3, or LAV, for lymphadenopathy associated virus.

HTLV-3 is the designation given by Dr. Robert Gallo and colleagues at the National Cancer Institute, co-discoverers of the virus and leaders in the American research effort. LAV is the name used by Dr. Luc Montagnier and associates at the Pasteur Institute in Paris, also credited as discoverers of the virus.



AIDS Health Services Program Launches in 11 U.S. Cities

The AIDS Health Services Program launches with $17.2 million in funding for patient-care projects in 11 major cities.

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Created by the Robert Wood Johnson Foundation, the AIDS Health Services Program seeks to replicate Ward 86’s San Francisco Model of HIV Care nationwide — but with an emphasis on tailoring programs to meet the needs in local context.

The goals of the program are to develop community-based services for persons with AIDS and to determine factors that facilitate or impede service.

The foundation starts with nine projects located in 11 communities: Atlanta, Dallas, Fort Lauderdale, Miami, Nassau County (NY), New Orleans, Newark, Jersey City, Seattle, and West Palm Beach.

The AIDS epidemic in each site varies substantially.  Lack of health insurance represents a problem for the majority of clients in states having the most restrictive Medicaid policies (Atlanta, New Orleans, and Dallas) and in communities where a large proportion of clients enter the program before their condition progresses to AIDS (Miami, Fort Lauderdale, and West Palm Beach).

Between 1987 and 1990, the average annual population with AIDS in program sites increase 126% (with increases ranging from 91% to 175%). During that period, the average increase in the number of persons alive with an AIDS diagnosis in these eleven cities is 191%, ranging from 181% to 257%.

The men and women attempting to build a network of coordinated services for persons with HIV/AIDS find themselves with an extremely difficult task.  As the epidemic progresses, there is a substantial increase in the scope of the epidemic as well as change in the racial, sex, and risk-group composition of HIV-infected persons.

Program staff have to cope with confusing state and federal policy, complicated by changes in medical treatment and in the conceptualization of AIDS. In 1986, AIDS is still perceived as an acute, fatal illness, and policies for expanding terminal care benefits are the focus of discussion. However, soon the focus would shift to early intervention and ongoing treatment programs for a new chronic disease.

April 29, 1987
Western Blot: FDA Releases Updated HIV Test

FDA approves a new, more specific test for HIV antibodies, the Western blot blood test kit.

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For several years, the HIV-1 Western blot would be considered the “gold standard” for laboratory diagnosis of HIV-1 infection, but is no longer recommended. The two main reasons for this are the inability of the Western blot to detect acute infection and the potential to misclassify HIV-2 infection as an HIV-1 infection.

A report in Nature in June 1993 would conclude that researchers need to “reappraise” the use of the Western blot antibody tests as a diagnostic and epidemiological tool for HIV infection.

August 14, 1987
CDC Updates Guidelines for Counseling & Antibody Testing

The CDC releases guidelines for public health agencies to help them reduce fear and concerns as they implement HIV testing programs.  The report encourges agencies to target outreach to at-risk populations and strengthen policies for patient confidentiality.

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The report, titled Perspectives in Disease Prevention and Health Promotion: Public Health Service Guidelines for Counseling and Antibody Testing to Prevent HIV Infection and AIDS, reflects the strong stance by the CDC against the unauthorized disclosure of personal information and inappropriate discrimination against those who seek to be tested.

Per the guidelines, health agencies should endeavor to provide ready, confidential access to HIV testing to those most at risk of HIV infection.

As examples, the report cites programs offering counseling and testing to gay men, IV-drug users, persons with hemophilia, the sexual and/or needle-sharing partners of these persons, and patients of sexually transmitted disease clinics.

The report also addresses the issue of false-positive HIV test results and its impact, stating that most false-positives are due to human error and more precautions should be used by medical personnel to ensure the accuracy of results.

“All laboratories should anticipate the need for assuring quality performance of tests for HIV antibody by training personnel, establishing quality controls, and participating in performance evaluation systems,” the report advises.


August 21, 1987
Universal Precautions Introduced to Medical Environment

CDC updates its recommendations for the prevention of HIV transmission in healthcare settings, calling for medical workers to practice universal precautions.

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The report emphasizes the need for healthcare workers to consider all patients as potentially infected with HIV and/or other blood-borne pathogens and to adhere rigorously to infection-control precautions for minimizing the risk of exposure to blood and body fluids of all patients.

The CDC defines healthcare workers as “persons, including students and trainees, whose activities involve contact with patients or with blood or other body fluids from patients in a healthcare setting.”

Universal precautions are listed in the report, along with precautions for invasive procedures, dentistry, dialysis, laboratory procedures, and autopsies and mortuary work.

November 13, 1987
AMA Declares Ethical Obligation to Treat PWA’s

The American Medical Association declares that doctors have an ethical obligation to care for people with AIDS, as well as for those who have been infected with the virus but show no symptoms.

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In a response to reports that some doctors are refusing to treat patients who are HIV-positive , the AMA advises physicians that it is unethical to deny care in such situations if the care required is within the doctor’s normal range of practice.

AMA ethics council also tells physicians that if a patient carrying the AIDS virus refuses to discontinue dangerous sexual practices, a doctor should notify public health authorities and even take it upon himself to directly inform individuals who may be in danger of infection.

The new AMA strictures conflict with California law, under which it is illegal for a doctor, without the patient’s consent, to tell anyone a person has tested positive for the AIDS virus or has AIDS.

The AMA states that no evidence exists that large numbers of doctors have refused to treat patients who tested positive for the AIDS virus.

But an AMA spokesperson concedes, “There have been physicians who have chosen to make public statements that they will not treat HIV-positive people. Those statements have generated tremendous amounts of discussion and debate.”

February 12, 1988
First AIDS Drug Released under New FDA Rules

Trimetrexate becomes the first AIDS drug given pre-approval distribution status under new FDA regulations.

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Trimetrexate was used to treat pneumocystis carinii pneumonia in AIDS patients who could not tolerate standard treatments.

May 6, 1988
New Study: Human Saliva Prevents Spread of AIDS Virus

A new study suggests that human saliva contains substances that prevent the AIDS virus from infecting white blood cells.

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In the study, published in the May issue of The Journal of the American Dental Association and reported widely in the media, the researchers tested saliva from three healthy men aged 35, 40 and 42. Researchers determined that the subjects were not infected by HIV and they were not known to be at high risk of infection.

The researchers said the finding might help explain why no cases have been documented in which the AIDS virus was transmitted from person to person through saliva.

The research was led by Philip Fox, M.D., who cautioned that the study results do not eliminate the possibility of HIV infection from oral sex or deep kissing.  Dr. Fox explained that the virus could enter the bloodstream through cuts in the mucous membranes that line the mouth or it might be able to infect cells on the surface of mucous membranes.

In 1999, researchers at the University of Texas Medical Branch at Galveston would conduct a study that confirmed the results of the 1988 research.

UT researchers Samuel Baron, Joyce Poast and Miles W. Cloyd sought to confirm the results of Fox’s 1988 study and subsequent studies that showed that proteins in saliva seem to neutralize or disable the AIDS virus, Published in the Archives of Internal Medicine, the UT study would indicate that saliva inactivates more than 90% of the HIV-infected blood cells by breaking the virus apart into non-infectious components.

U.S. Launches Study on Transmission in Women & Infants

An epidemiologic study of HIV transmission during pregnancy and birth is launched by the National Institute of Allergy and Infectious Diseases and the National Institute of Child Health and Human Development.

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The Women and Infants Transmission Study (WITS) captured data on the natural history of HIV infection in pregnant women and their infants.  The study followed the women with their infants through the infants’ first few years of life.

Conducted at obstetric/gynecologic and pediatric clinics in Boston, Chicago, Manhattan, Brooklyn, Houston, and San Juan, the first phase of the study captured data from 788 HIV-infected pregnant women and 657 infants born to them.

Of the women studied in the initial phase of the trial, 82% were women of color, which was intentionally representative of infected women in the U.S.  The researchers found they needed to be resourceful in finding ways to retain participants, because many in the cohort had low incomes and histories of substance abuse.

In 1993, WITS would receive another $5 million in funding and expand to include participants from additional cities.  Over the years, data collected from WITS would become intrumental in determining treatment and transmission prevention strategy for women and infants.

Volunteers Enroll in Clinical Trials for HIV Vaccine

National Institute of Allergy and Infectious Diseases, headed by Anthony Fauci, M.D., creates the first U.S. cooperative HIV vaccine clinical trials group and begins enrolling volunteers.

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NIH established the Office of AIDS Research (OAR), which then launched the AIDS Vaccine Evaluation Group (AVEG) to oversee the first study of an experimental AIDS vaccine.

At the time, researchers and the medical community were hopeful that a vaccine would be quickly developed and rolled out to the general public.  But in spite of the optimism expressed by many, Dr. Anthony Fauci published a Public Health Report that warned that developing a HIV vaccine would be difficult.  Dr. Fauci listed the following as issues that complicate the development of an effective AIDS vaccine:

– the lack of “an appropriate animal model for AIDS,”

– the absence of a defined protective immune response in persons infected with HIV,

– the long latent period between initial infection and the development of symptoms,

– the existence of multiple strains of HIV, and

– the spread of HIV by way of cell-associated virus.

“When HIV was discovered and established as the cause of AIDS in 1983–1984, many people believed that a vaccine would be easily developed and rapidly deployed.  After all, vaccinologists had been very successful in developing vaccines for a whole range of viral diseases,” José Esparza of the Bill and Melinda Gates Foundation wrote in 2013.  “However, the paradigm that allowed the development of most existing viral vaccines, which is based on the recreation of the protective immunity that develops after natural infection, does not work in the case of HIV.”

By 2003, the first wave of vaccine trials would end in negative results and failure.

Still today, scientists continue their quest to develop a vaccine.  Extensive studies are underway to determine how HIV is able to avoid the immune responses spurred by vaccines.  In an article for the Association of American Medical Colleges, David Diemert, M.D. explained the challenge.

“From the very second HIV infects a person, it starts to escape from the immune response,” said Dr. Diemert, clinical director of vaccine research at the George Washington University School of Medicine and Health Sciences.

November 25, 1988
CDC Study: One of Every 500 College Students Infected with HIV

One out of every 500 college students are infected with HIV, according to a new study released by the Centers for Disease Control and Prevention.

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As part of its series of HIV surveys and studies, the CDC collaborated with the American College Health Association to assess HIV infection in college students.  For the first 12,000 students tested, a seroprevalence of HIV of 0.2% was found.  The majority of seropositive specimens came from male students.

The tests were conducted anonymously on blood specimens drawn from students at student clinics.  The initial results came from student specimens from 17 of 19 participating campuses.  The researchers stated that the survey did not include a random sampling of all college students, just students who had blood drawn at their campus health center.

The researchers conclude that “these results demonstrate that HIV infection and the potential for its transmission are present on many college campuses.”  They interpret the data to mean that older students and men are at greatest risk in this population.

The colleges participating in the study were:

Central Missouri State University
Emory University
Mississippi State University
Northwestern University
Rutgers University
San Diego State University
Southern Illinois University
University of California – Berkeley
University of Colorado
University of Connecticut – Storrs
University of Georgia
University of Kansas
University of Maryland – Baltimore County
University of Maryland – College Park
University of Massachusetts – Amherst
University of New Hampshire
University of Southern California
University of Texas – Austin
University of Washington

February 20, 1989
Doctor Skirts NIH Delay in PCP Treatment Protocol

When a CDC statistician tells AIDS activist Michael Callen that 30,534 Americans have died of AIDS-associated Pneumocystis pneumonia (PCP), Callen’s physician responds with information indicating that many of these deaths could have been prevented with existing (but “unapproved”) treatment.

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Dr. Joseph Sonnabend, Callen’s doctor, would later write about treatment to prevent PCP with “a drug that had been known to prevent this kind of pneumonia since 1977.”

The doctor would blame NIH Director Dr. Anthony Fauci for the delay in this treatment being available on a widespread basis, saying that Dr. Fauci “wanted data from a clinical trial of Bactrim for PCP prophylaxis in AIDS before he would recommend its use.”

Dr. Sonnabend says he refuses to wait for the NIH to collect data and reach its conclusions, revealing that he is already prescribing Bactrim (also known as Septra, Septrin or co-trimoxazole) and Dapsone to patients he routinely deems to be at risk for PCP, with positive results in his patients.

Years later, looking back at this time, Dr. Sonnabend would write:  “People were dying of PCP at a terrifying rate; I and some other physicians could not wait for these recommendations.”

June 16, 1989
CDC Issues Treatment Guidelines for PCP Prevention

The U.S. Centers for Disease Control and Prevention issues the first guidelines for preventing Pneumocystis carinii pneumonia, known as PCP, an infection which often leads to the severe illness and death for people living with AIDS.

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The guidelines recommend a regimen of two compounds to prevent the onset of PCP: trimethoprim-sulfamethoxazole and pentamidine.  The CDC bases its recommendations on a study of 60 adults living with AIDS, which suggest that those who received treatment have fewer episodes of PCP and lived longer, compared with untreated patients.

Trimethoprim-sulfamethoxazole, a combination of the antibiotics sulfamethoxazole and trimethoprim, commonly causes side effects in patients that include nausea, vomiting, diarrhea, and loss of appetite.

Pentamidine, given as an aerosol in a nebulizing device, commonly causes adverse effects including coughing, difficulty breathing, difficulty swallowing, and chest pain or congestion.

The Public Health Service recommends physicians to start this treatment with:

  • any HIV-infected adult patient who has already had an episode of PCP, and
  • those whose CD4+ cell count is less than 200/mm3 (or less than 20% of total lymphocytes).

CD4+ cells would soon be referred to as “T-helper” or “T4 cells,” because one of their main goals is to send signals to other kinds of immune cells, which then destroy infectious particples.

Patients with CD4+ cell counts of less than 100/mm3 (or less than 10%), as well as patients with oral thrush or persistent fever, are at particularly high risk for PCP, the report states.

According to HIV.gov, a healthy T cell count should be between 500 and 1,600 T cells per cubic millimeter of blood (cells/mm3).

June 23, 1989
CDC Updates Guidelines on Transmission Prevention for Healthcare Workers

The Centers for Disease Control releases updated guidelines to help prevent the transmission of HIV and Hepatitis to healthcare and public safety workers.

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The guidelines are a response to recently enacted legislation, the “AIDS Amendments of 1988” in the HOPE Act of 1988, passed by Congress and signed by President Ronald Reagan on Nov. 4, 1988.

The legislation calls for the Secretary of Health and Human Services, acting through the Director of the CDC, to “develop, issue, and disseminate guidelines to all health workers, public safety workers (including emergency response employees) … concerning methods to reduce the risk in the workplace of becoming infected with the etiologic agent for AIDS, and circumstances under which exposure to such etiologic agent may occur.”

The report states that, as of September 1988, a total of 3,182 (5.1%) of the 61,929 adults reported to be living with AIDS are employed in a healthcare setting.  Of the healthcare workers with AIDS, the means of HIV acquisition is “undetermined” for 5% of them (169 workers), suggesting that infection occurred in the workplace.

Of these 169 health-care workers with AIDS, 44 are interviewed directly or have other background information available about their cases.  The occupations of these 44 are:

  • nine nursing assistants
  • eight physicians, four of whom are surgeons
  • eight housekeeping or maintenance workers
  • six nurses
  • four clinical laboratory technicia)ns
  • two respiratory therapists
  • one dentist
  • one paramedic
  • one embalmer
  • four others who did not have contact with patients

Eighteen of these 44 health-care workers report parenteral (i.e., not delivered via the intestinal tract) and/or other non-needle-stick exposure to blood or other body fluids from patients in the 10 years preceding their diagnosis of AIDS.  None of the exposures involve a patient with AIDS or known HIV infection.

June 26, 1989
Chief Researcher Calls for Access to Experimental Treatment

Dr. Anthony Fauci, head of the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID), endorses giving HIV-positive people who do not qualify for clinical trials access to experimental treatments.

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In a front-page article by Gina Kolata in The New York Times, Dr. Fauci calls for a new system that would allow patients far greater access to experimental drugs.

This marks a major turnaround in government policy, which restricts access to experimental drugs with the reasoning that patients would have no reason to join a clinical trial if they could get a drugs by other means.

Since his early involvement in developing treatment for HIV/AIDS, Dr. Fauci had adhered to the National Institutes of Health policy that research need not focus on the immediate welfare of patients.

“It was clear to me that Fauci was inclined to enforce the paternalistic medical tradition in which he had trained: doctors and scientists were unquestioned authorities, and drug development had to follow a rigid process that included animal testing and rigorous clinical trials. Otherwise, the benefits and the risks of these drugs could not be adequately assessed,” writes Michael Specter in his profile of Dr. Fauci for The New Yorker in April 2020.  Specter covered the AIDS epidemic for the Washington Post in the 1980s.

AZT (azidothymidine) was the only approved drug available to treat HIV/AIDS, but it had harsh side effects.  When new clinical studies began, involving cocktails of AZT and similar compounds, tens of thousands of people asked to participate.  But volunteers were rejected if they used other experimental drugs.  And many more didn’t have the means to get to facilities and practitioners conducting the clinical trials.

But then the activist group ACT UP started transforming the frustration into anger, and the anger into well-publicized demonstrations against the research community.

“They started becoming amazingly iconoclastic and confrontational, and that scared the hell out of the scientists, who were fundamentally quite conservative,” Dr, Fauci tells Specter in The New Yorker profile. “When they were demonstrating on the NIH campus, disrupting Wall Street, disrupting St. Patrick’s Cathedral, instead of listening to them, scientists withdrew.”

However, Dr, Fauci decided to look beyond the activists’ furious rhetoric and style, and began to listen to what they had to say.

“And what they were saying made absolutely perfect sense,” Dr. Fauci says.

Faced with mounting evidence that his cautious approach made no sense, he reversed himself and promoted activist demands for more access to experimental treatments.

In the process, “Fauci transformed from a conventional bench scientist into a public-health activist who happened to work for the federal government,” writes Specter.

January 19, 1990
Report of HIV Transmission via Dentistry Alarms Public

The U.S. Centers for Disease Control and Prevention reports the transmission of HIV to a patient through a dental procedure performed by an HIV-positive dentist in Florida, releasing a wave of panic across America.

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The CDC report describes the first known case of clinical transmission of HIV:  Kimberly Ann Bergalis, a 19-year-old college student, underwent a molar extraction in December 1987.  About two years later, she would test positive with a strain of HIV related to that of her dentist.

The dentist, Jeffrey Acer, would be villified in the press, even in the years following his death in September 1990.  He would be openly called a lunatic and a murderer, and accused of deliberately infecting his patients — which was in no way supported by facts.

Reported to the CDC by the Florida Department of Health and Rehailitative Services (HRS), the case described Bergalis as having no identified risk factor for HIV infection and that, at some time following an extensive dental procedure with Dr. Acer, she became infected with an HIV strain related to the one that he had.

In an open letter to his patients, Dr. Acer wrote: “I am a gentle man, and I would never intentionally expose anyone to this disease. I have cared for people all my life, and to infect anyone with this disease would be contrary to everything I have stood for.”

The CDC suggested that during the dental procedures, “higher titers of virus may have been present in the dentist’s blood and he may have been more likely to transmit virus than earlier in the course of his HIV disease.”

Following the notification, two more of Acer’s former patients would test positive with a strain similar to his.  In addition, a third infected patient would be identified by the Florida Department of Health and Rehabilitative Services (HRS) and a fourth would contact the CDC directly to report that she was HIV-infected and a former patient of the dentist.

The Florida HRS would then reach out to 1,100 additional persons who potentially were patients of Dr. Acer to offer counseling and HIV-antibody testing.  Of them, 141 are tested, and all results were negative.  In addition, none of the dentist’s 14 employees tested positive for HIV.

Staff members of the dental office told HRS officials that barrier precautions had been introduced into the practice by early 1987 and that all staff, including the dentist, wore latex gloves and surgical masks for patient-care activities. Staff reported that they changed gloves and washed their hands between most patient contacts; occasionally, however, they washed gloves rather than changed them between patient contacts.  Additionally, staff reported that by 1987, all surgical instruments were autoclaved.

According to medical records reviewed by the CDC, Dr. Acer was diagnosed with symptomatic HIV infection in late 1986 and AIDS in September 1987.  While he was in practice, he had no record of peripheral neuropathy, dementia, thrombocytopenia or other bleeding disorder, hand dermatitis, or injury.

Dr. Acer closed his practice in 1989 after his T-cell (CD4 lymphocyte) count dropped under 200.  He would die on Sept. 30, 1990 at the Hospice of Palm Beach County at West Palm Beach with his parents at his side.

Kimberly Bergalis would spend her final years advocating for the mandatory testing of medical professionals.  She is described as “the one AIDS patient the AIDS community will not embrace, a frightening and hostile new public symbol of an epidemic the AIDS community thought it had tamed.”

Larry Gostin, professor of health law at Harvard University, would tell The Washington Post in September 1991, “What Kimberly Bergalis symbolizes is … that AIDS is to be feared and that it can be contracted easily in health-care settings. She has created fear.”

Still, Bergalis became a sympathetic victim to many, and would go on to testify to Congress in a 20-second statement that became the world’s headline:

“I’d like to say that AIDS is a terrible disease that you must take seriously. I did nothing wrong, yet I’m being made to suffer like this. My life has been taken away. Please enact legislation so that no other patient or health care provider will have to go through the hell that I have. Thank you.”

Soon, the Senate would pass a bill, sponsored by North Carolina Sen. Jesse Helms, that required healthcare workers to reveal their HIV status or face imprisonment.

Bergalis would die of AIDS-related illness on Dec. 8, 1991 at the age of 23.

January 26, 1990
U.S. Updates Guidelines for Reducing Healthcare Worker Exposure

On January 26, the U.S. Public Health Service issues a statement on managing occupational exposure to HIV, including considerations regarding post-exposure use of the antiretroviral drug, AZT.

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The CDC issues a report reviewing the PHS recommendations for the management of occupational exposures that may place workers at risk of acquiring HIV infection, with a focus on those administering AZT treatment.

May 1, 1990
AIDS Cases Rising Among Heterosexuals

Cases attributed to heterosexual transmission are growing faster than any other category of AIDS cases, according to the U.S. Centers for Disease Control.

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The CDC reports that from 1988 to 1989, AIDS cases caused by heterosexual transmission jumped 36%.  Of the infected heterosexuals who are women, many give birth to infants who are also infected.

”The heterosexual epidemic is no myth,” Dr. Jerome Groopman, head of the AIDS program at Harvard’s New England Deaconness Hospital, told The New York Times.  ”It is real.”

According to the CDC, about 128,319 cases of fully symptomatic AIDS were reported from 1981 through March 1990. Of those, CDC officials estimate that about 6,231 — 5% — have been cases in which the disease was transmitted by heterosexual sex.

The NYT article noted that federal statistics likely reflect an undercount of heterosexual transmission of AIDS, because the CDC’s reporting system is ”hierarchical,” meaning that AIDS cases were attributed to homosexual sex, intravenous drug use and all other risk categories first. Only those that did not fit into these categories were put in the “heterosexual transmission” category.

Thomas C. Quinn, an AIDS researcher at the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, told the NYT that there is a rapid increase in heterosexually transmitted disease in several cities, especially those of the East Coast, including Newark, Philadelphia, Baltimore, Washington and Miami.

Dr. Quinn recently presented a paper at an AIDS conference at Johns Hopkins University, where he and his colleagues described syphilis as one of the key factors in spreading AIDS among heterosexuals in the inner city.

The NIAID researchers studied 4,863 patients in two inner city clinics in Baltimore that treat sexually transmitted diseases. Among the heterosexuals who said they did not use intravenous drugs, those who had syphilis were seven to nine times more likely to have AIDS than other patients at the clinic.

In December 1988, NIAID launched the Heterosexual AIDS Transmission Study (HATS) to collect data on male and female heterosexuals at high risk of AIDS who are not IV drug users.

October 26, 1990
FDA Adds AZT to Pediatric AIDS Treatment Options

The U.S. Food and Drug Administration approves use of zidovudine (AZT) for pediatric AIDS.

May 22, 1992
Rapid HIV Blood Test Gives Results in 10 Minutes

FDA licenses a rapid HIV diagnostic test kit which gives results from a blood test in 10 minutes.

Learn More.

The FDA licenses Murex SUDS HIV-1, a 10-minute diagnostic test kit which can be used by health professionals to detect the presence of HIV Type 1.

As the only rapid enzyme immunoassay (EIA) approved for diagnostic use in the U.S., the test is manually performed by mixing a small amount of the patient’s blood with an antibody agent to which only HIV-1 antibodies will attach.

This test is considered by researchers to be part of the third wave of HIV tests, following the ELISA and Western Blot tests of the mid-1980s.  A 1993 clinical trial analyzing almost 2,000 test samples would show the SUDS HIV-1 test to give false-positive results at a relatively high rate.


female condom
May 7, 1993
FDA Approves Female Condom

The U.S. Food and Drug Administration (FDA) approves the female condom, giving women a new way to protect themselves from sexually-transmitted diseases and unwanted pregnancy..

Learn More.

The condom, which is ma nufactured by Chartex International, becomes available over the counter at most major drug stores in Southern California, under the name Reality Female Condom.

Although the female condom gives women more options for birth control, it is slow to catch on with the general public.

Donna Diaz, a representative of Planned Parenthood of Los Angeles, tells California State University’s campus newspaper that the female condom is not popular because it is “more awkward to use” than the male condom.

“It’s not as effective as the male condom and it’s very inconvenient to use,” she says.

However, Holly Sherman, spokeswoman for The Female Health Company — which markets and distributes the condom — disagrees, saying the female condom provides protection from disease on genital areas because there is “less skin touching skin” and the chance of transmitting a disease is less likely.

The female condom has a sheath material and a flexible inner ring, and is inserted similar to a diaphragm.  A woman squeezes the ring and inserts it as far as possible into the vagina. The ring then covers the cervix. Its sheath material holds the condom in place. The outer ring lines the vaginal wall and helps cover the lips of the vagina.  The sexual partner must stay within the confines of the female condom or it’s ineffective.

U.S. Launches Two Research Studies Focused on Women

The Women’s Interagency HIV Study and HIV Epidemiology Study begin; both are major U.S. federally funded research studies on women and HIV/AIDS.


Learn More.

The Women’s Interagency HIV Study establishes a multi-center, prospective, observational cohort study of women living in the U.S. who are either HIV-infected or at risk for HIV acquisition.

The program would play an important role in the National Institute of Allergy and Infectious Diseases’ effort to understand the current epidemiology of HIV infection, disease progression, treatment use and outcomes, and related co-morbidities among U.S. residents with HIV.

Understanding differences in HIV disease and treatment outcomes between women compared to men, and in different racial and ethnic groups, is a critical public health goal.  The clinical research consortium is an integral part of the NIAID portfolio of research on HIV in women.

December 18, 1993
CDC Ties Definition of AIDS to T-cell Counts

The U.S. Centers for Disease Control and Prevention expands its definition of AIDS, declaring those with T-cell (CD4) counts below 200 to have AIDS.

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In a report, the CDC revises its case definition of AIDS to emphasize the clinical importance of the CD4+ T-lymphocyte count in the categorization of HIV-related clinical conditions.

In the same MMWR, CDC adds three new conditions — pulmonary tuberculosis, recurrent pneumonia, and invasive cervical cancer — to the list of clinical indicators of AIDS.  These new conditions mean that more women and injection drug users are expected be diagnosed with AIDS.

May 20, 1994
CDC Issues Guidelines for Organ and Tissue Transplants

The U.S. Centers for Disease Control and Prevention issues guidelines for preventing HIV transmission during organ and tissue transplants.

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The guidelines follow a report to the CDC about a case of HIV transmission from a screened, antibody-negative donor to several transplant recipients.

Titled, Guidelines for Preventing Transmission of Human Immunodeficiency Virus Through Transplantation of Human Tissue and Organs. the report seeks to reduce “the already low risk of HIV transmission by transplantation of organs and tissues.”

August 5, 1994
Researchers Recommend AZT to Prevent Mother-to-Infant Transmission

The U.S. Public Health Service recommends that pregnant women be given the antiretroviral drug AZT to reduce the risk of perinatal transmission of HIV.

Learn More.

Following a workshop to develop recommendations for the use of AZT with HIV-infected women who are pregnant, the Public Health Service determines that AZT administered to a selected group of HIV-infected women and their infants is successful in reducing the risk of HIV transmission by approximately 66%.

In its report, the Public Health Service states that because the clinical status of many HIV-infected women may differ from that of the women in the trial, the recommendations should be tailored to each woman’s clinical situation.

“The potential benefits, unknown long-term effects, and gaps in knowledge about her specific clinical situation must be discussed with the woman,” the report states.  “This information is intended to provide a basis for discussion between the woman and her healthcare provider so that the woman can weigh the risks and benefits of such therapy and make informed decisions about her treatment.”

December 23, 1994
FDA Approves Saliva HIV Test

The U.S. Food and Drug Administration approves an oral HIV test, the first non-blood-based antibody test for HIV.

Learn More.

FDA says the test, which uses fluid from the mouth instead of blood, will be available only from doctors and will be administered only by people trained to do so.

“As long as a positive test is followed up with a blood test and as long as there is appropriate counseling available, it is a reasonable thing to do,” Dr. Jeff Lawrence tells The New York Times.  Dr. Lawrence is a consultant to the American Foundation for AIDS Research.

Studies show that for every 100 people infected with HIV, the oral-fluid-based test will miss one or two, and for every 100 people who are not infected, test results will be incorrectly positive for approximately two people.

July 7, 1995
U.S. Recommends HIV Testing for Pregnant Women

To address the increasing epidemic of HIV infection among women and their infants, the U.S. Public Health Service encourages pregnant women to voluntarily be tested for the virus.

Learn More.

Developed in collaboration with public health officials, service organization leaders and federal researchers, the recommendation for HIV testing stressed the importance of early diagnosis of infection for the health of both women and their infants.

In an edition of the Centers for Disease Control and Prevention’s MMWR, the results of a clinical trial are announced as a significant advance in HIV-related treatment and prevention.  The placebo-controlled, clinical trial indicated that the administration of zidovudine to HIV-infected pregnant women and their newborns could reduce the risk for perinatal transmission of HIV by approximately 66%.

With this CDC-tested treatment, pregnant women who are HIV-positive could benefit from an early diagnosis.

HIV can be transmitted from an infected woman to her fetus or newborn during pregnancy, during labor and delivery, and during the postpartum period (through breastfeeding).

At the time, researchers had confirmed that transmission of HIV to a fetus could occur as early as the eighth week of gestation, but most perinatally transmitted infections occurred shortly before or during the birth process.  The CDC estimated that breastfeeding could increase the rate of transmission by 10-20%.

In a 2003 interview with PBS News Hour, Dr. Mary Glenn Fowler, the lead CDC researcher on maternal-to-child HIV transmission, would credit the decline in babies being born with HIV to women following the CDC recommendation to get tested for HIV and the availability of the zidovudine treatment.

“It’s been one of our really strong successes in the HIV epidemic,” Dr. Fowler told PBS.  “In the early ’90s we had approximately between 1,000 and 2,000 women delivering infected babies each year, and we have really reduced that [in 2003] down to close to 280 to 370 babies being infected.  So it’s almost greater than an 80% decline, and it’s related to use of anti-retrovirals during pregnancy as well as to obstetrical intervention, such as scheduled C-section prior to the onset of labor.”

July 14, 1995
CDC Issues Guidelines on Prevention of Opportunistic Infections

The U.S. Centers for Disease Control and Prevention issue the first guidelines to help healthcare providers prevent opportunistic infections in people living with HIV.

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In a precursor to a full report that would be published in the August edition of Clinical Infectious Diseases, the CDC announces that healthcare providers can prevent opportunistic infections in HIV-positive people by adhering to a set of guidelines.

The set of recommendations are rated according to the strength of the recommendation and the quality of evidence supporting the recommendation.  The guidelines address prevention techniques for adults, adolescents and children.

September 22, 1995
CDC Issues Report Supporting Needle-Exchange Programs

The Centers for Disease Control and Prevention endorses a National Academy of Sciences report that concludes needle-cxchange programs are an effective method of preventing HIV infection.

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In its review of Syringe Exchange Programs — United States, 1994-1995, a report by the National Academy of Sciences. the CDC expresses support for needle-exchange programs, stating that they are effective in reducing HIV transmission associated with drug injection.

The report states that as of December 1994, 35.3% of the 435,319 cases of AIDS reported among adults are associated with IV drug use.  In addition, injection of illegal drugs is the risk behavior most frequently associated with heterosexual and perinatal transmission of HIV in the U.S.

The goal of needle-exchange programs is to reduce HIV transmission associated with IV drug use by providing sterile syringes in exchange for used, potentially HIV-contaminated syringes.

December 7, 1995
FDA Approves First Protease Inhibitor

The U.S. Food and Drug Administration approves the first of a new class of drugs — protease inhibitors — designed to attack the HIV virus.  This ushers in a new era of highly active antiretroviral therapy (HAART), which has the potential to extend life expectancies for people living with HIV.

Learn More.

The drug, saquinavir, manufactured by Hoffmann-La Roche, is a member of the new class of drugs called protease inhibitors that attack the ability of the HIV virus to reproduce. It does so by inhibiting an enzyme called protease that is crucial to HIV reproduction.

The first antiretroviral therapies developed for people with HIV are nucleoside reverse-transcriptase inhibitors (NRTIs), but these drugs would prove to be only partially effective. The addition of an orally administered protease inhibitor reduces HIV plasma concentrations and increases T-cell (CD4+) counts to levels that enable patients to have fairly normal life expectancies.

This combination — two nucleoside analogs and a protease inhibitor — is now considered the cornerstone of active antiretroviral therapy.


July 7, 1996
Conference Attendees Optimistic about HAART Treatment

The 11th International AIDS Conference in Vancouver highlights the effectiveness of highly active antiretroviral therapy (HAART), creating a period of optimism.

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The first international AIDS conference in two years, the event is one of the more eagerly anticipated scientific meetings in years. Data on promising new drug treatments for AIDS, insights into the ways HIV infects cells, and the mechanisms of “host resistance” to that attack are scheduled to top the agenda.

Remarkable gains in using combinations of costly new and old drugs promise to slow the progression of AIDS and to allow many people infected with HIV to live longer and healthier lives, conference presenters announce to attendees.

With 15,000 delegates, journalists and commercial exhibitors in attendance, it is the largest conference so far.  The theme is “One World, One Hope.”

While it seems that AIDS may finally become a managable disease in developed countries, less developed nations are struggling to scrape together the resources to provide necessary treatment and services to people with HIV and AIDS.

Data would be released at the conference that estimate a total of 21.8 million people to be currently living with HIV/AIDS, the vast majority of whom live in developing countries.


December 30, 1996
Researcher David Ho Develops ‘Hit Early, Hit Hard’ Treatment

HIV/AIDS researcher Dr. David Ho is named TIME magazine “Man of the Year” for advocating a new strategy for treating HIV – “hit early, hit hard.”

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Dr. Ho’s approach to HIV treatment involves placing patients on new, more aggressive treatment regimes earlier in the course of their infection in hopes of keeping them healthier longer.

“We set up several studies in mid-1995, and by mid-1996 we were able to show that for the first time we could drop the virus down so that it’s not detectable and keep it down for a year or more,” Dr. Ho tells Frontline in a series of interviews in 2005-2006.  “That was what was later hailed as the major advance in HIV therapeutics.”

Total of U.S. AIDS Cases Begins to Decline

The number of new AIDS cases diagnosed in the U.S. declines for the first time since the beginning of the epidemic.

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Ending the 16-year incline of cases, 1996 data shows that AIDS-related deaths dropped 23% from 1995 to 1996.

Experts credit the downturn with the availability of aggressive new therapies that keep infected patients healthier, as well as the possibility that fewer people are becoming infected in the first place.

The positive trends do, however, mask a troubling development: cases among women and heterosexuals who do not use drugs, particularly minorities, are on the rise.

African-American women are particularly at risk. In 1994, officials at the Centers for Disease Control reported that black women were almost 15 times as likely as white women to test positive for HIV.

”My new cases among women are often young women, coming in with a first pregnancy who are being tested as part of that pregnancy and finding out that they are HIV-positive,” said Dr. Mary Young, who treats AIDS patients at Georgetown University here.

“The gay community has done a wonderful job of getting the message out. But I don’t know that we target young African-American women very well.”

September 26, 1997
FDA Approves First Antiretroviral Drug Combo

The U.S. Food and Drug Administration approves Combivir, the first one-pill combination of the two most widely used antiretroviral medications for AIDS and HIV infection.

Learn More.

A combination of Retrovir (zidovudine or AZT) and Epivir (lamivudine or 3TC), Combivir decreases the number of pills people with HIV have to take daily.

As the first combination agent, the medication significantly simplies HIV therapy.  Combivir becomes the gold standard nucleoside “backbone” until the mid-2000s, when the introduction of newer fixed-dose combinations with improved tolerability and toxicity arrive.


Protease Inhibitor Use Leads to Drug Resistance in Some

As a greater number of people begin taking protease inhibitors, resistance to the drugs becomes more common, and drug resistance emerges as an area of grave concern within the AIDS community.

April 24, 1998
CDC Issues Guidelines for Antiretroviral Therapy

The Centers for Disease Control and Prevention issues the first national treatment guidelines for the use of antiretroviral therapy in adults and adolescents with HIV.

June 1, 1998
Sub-Saharan Africa Shows More Women Infected than Men

In June, UNAIDS reports that the number of women living with HIV/AIDS in sub-Saharan Africa now exceeds that of men.

U.S. Firm Begins Human Trials for Vaccine in Thailand

VaxGen, a San Francisco-based biotechnology company, begins conducting the first human vaccine trials in Thailand.

December 10, 1999
CDC Updates HIV Definition to Help Extend State Reach

he U.S. Centers for Disease Control and Prevention releases a new HIV case definition to help state health departments expand their HIV surveillance efforts and more accurately track the changing course of the epidemic.

Side Effects, Drug Resistance Call Therapy Strategy Into Question

Side effects and increasing evidence of drug resistance call into question the “hit early, hit hard” strategy.

November 7, 2002
FDA Approves New Rapid-Diagnosis Test

The U.S. Food and Drug Administration announces the approval of the OraQuick Rapid HIV-1 Antibody Test with 99.6% accuracy.  A second FDA-approved rapid HIV test, Single Use Diagnostic System for HIV-1, remains available.

Learn More.

Unlike other antibody tests for HIV, this blood test can be stored at room temperature, requires no specialized equipment, and may be used outside of traditional laboratory or clinical settings, allowing more widespread use of HIV testing.

The new test provides a result in about 20 minutes, while the fastest test currently in use takes 90 minutes.  In practice, however, most people who seek AIDS testing aren’t given their results for a week or more after they provide a blood sample.

The OraQuick Test requires that a person prick his finger and use a wire loop to capture a drop of blood. The drop is then put in a vial containing a diluting solution.

Then a paper tab attached to a cap is lowered into the solution. A dark line appears on the tab if it makes contact with certain universal blood proteins. If antibodies to HIV are present, a second dark line appears.

Public health officials are hopeful that the test will substantially increase the number of people seeking testing, and decrease the fraction who, once tested, never return for the results.

February 24, 2003
Early AIDS Vaccine Trial Fails

VaxGen, a San Francisco-based biotechnology company, announces that its AIDSVAX vaccine trial failed to reduce overall HIV infection rates among those who were vaccinated.

March 31, 2003
Gates Foundation Donates $60 Million to HIV Research

The Bill and Melinda Gates Foundation awards a $60 million grant to the International Partnership for Microbicides to support research and development of microbicides to prevent transmission of HIV.

Majority of New U.S. Infections Come from Lack of Knowledge

The U.S. Centers for Disease Control and Prevention (CDC) calculate that 27,000 of the estimated 40,000 new infections that occur each year in the U.S. result from transmission by individuals who do not know they are infected.

March 26, 2004
Diagnostic Test Based on Oral Fluid Samples Approved

The U.S. Food and Drug Administration (FDA) approves the use of oral fluid samples with a rapid HIV diagnostic test kit that provides the result in approximately 20 minutes.

September 22, 2006
CDC Revises Guidelines on HIV Testing

The U.S. Centers for Disease Control and Prevention (CDC) release revised HIV testing recommendations for healthcare settings, recommending routine HIV screening for all adults, aged 13-64, and yearly screening for those at high risk.

Study Indicates Medical Circumcision Reduces Risk for HIV

A study of Kenyan men suggests that medical circumcision reduces by 53% their risk of acquiring HIV during heterosexual intercourse.

Learn More.

Conducted by the University of Illinois at Chicago and supported by the U.S. National Institute for Allergy and Infectious Diseases and the Canadian Institute of Health Research, the analysis of the clinical trial confirmed the importance of established risk factors for HIV and identified practices (such as circumcision) that warrant further investigation.

The study’s researchers said their goal was to “determine whether male circumcision had a protective effect against HIV infection, and to assess safety and changes in sexual behaviour related to this intervention.”

After compiling data from 2,784 men aged 18-24 years in Kisumu, Kenya, the researchers concluded that male circumcision significantly reduces the risk of HIV acquisition in young men in Africa.

“Where appropriate, voluntary, safe, and affordable, circumcision services should be integrated with other HIV preventive interventions and provided as expeditiously as possible,” the report stated.


August 6, 2008
CDC Corrects Undercount of New HIV Cases

The U.S. Centers for Disease Control and Prevention release new U.S. HIV data showing a substantially higher infection rate than it previously estimated.

Learn More.

The CDC’s new report adjusts the previous number of new infections per year from 40,000 to 56,300.

The adjusted data did not represent an actual increase in the numbers of HIV infections, explained the CDC; instead, the data reflected a more accurate way of measuring new infections.  A separate analysis suggested that the annual number of new infections was never as low as 40,000 and that the rate of new infections was stable since the late 1990s.

October 6, 2008
Nobel Prize Awarded for 1983 Discovery of HIV

The Nobel Prize in medicine is awarded to two French virologists, Françoise Barré-Sinoussi, and Luc A. Montagnier, for their 1983 discovery of HIV, the virus that causes AIDS.

October 6, 2009
100th Antiretroviral Drug Approved

The U.S. Food and Drug Administration approves the 100th antiretroviral drug.

Learn More.

FDA announces that it has approved the 100th antiretroviral drug under the President’s Emergency Plan for AIDS Relief (PEPFAR).  Of the more than 100 products that have received either full or tentative FDA approval under the program, 29 are branded drugs and 71 are generics.

This achievement reflects a five-year-old regulatory process designed to fast-track the delivery of cheap HIV drugs to the developing world through the PEPFAR program.

The FDA process was launched in May 2004, in response to a call from activists, clinicians and members of Congress to use the WHO’s pre-certification drug list to make purchases of generic medications for PEPFAR-funded programs.  Instead, a process was devised to allow the FDA to certify generic antiretrovirals (ARVs) for PEPFAR purchase, even if the branded drug was still protected by U.S. patent laws.

HHS Secretary Kathleen Sebelius said in a statement, “This milestone exemplifies the dedication, caring, and hard work of all who strive to better the lives of those infected with or affected by HIV/AIDS.”

iPrEx Study Shows Risk Reduction in HIV-Negative Men

A new study shows that a daily dose of HIV drugs reduced the risk of HIV infection by 44% among HIV-negative men who have sex with men.

Learn More.

The National Institutes of Health announce these results from its iPrEx study, supporting the concept of pre-exposure prophylaxis (PrEP) in a targeted population.

April 11, 2011
Public Debates Transplant Ban of HIV-Infected Organs

Public debate begins on whether the longstanding ban on transplants of HIV-infected organs should be dropped .

July 13, 2011
CDC Study Supports Use of PrEP As Preventative Therapy

A new CDC study and a separate clinical trial (the Partners PrEP study) provide the first evidence that adaily oral dose of antiretroviral drugs used to treat HIV infection can also prevent new infections in individuals exposed to HIV through heterosexual sex.

July 17, 2011
Studies Confirm Efficacy of Antiretroviral Therapies

Scientists announce that two studies have confirmed that daily antiretroviral drugs can significantly lower the rates of HIV-related infection.

Learn More.

The announcement is made at the International AIDS Society’s Conference on HIV Pathogenesis, Treatment, and Prevention in Rome on July 17-20.  The studies show that individuals taking daily antiretroviral drugs experienced infection rates more than 60% lower than those on a placebo.

November 20, 2011
Rate of Global Infections & Deaths Level Off

New data shows global HIV prevalence is much lower than previously believed (33 million cases instead of 40 million).

Learn More.

In its report Global HIV/AIDS Response: Epidemic update and health sector progress towards Universal Access, the World Health Organization (WHO), UNAIDS, and UNICEF announce that improved surveillance data is providing a better worldwide picture of the epidemic than previously thought.

The data also indicates a decline in the numbers of new infections and people dying from AIDS-related illnesses, due in part to HIV-prevention programs and antiretroviral therapy.

The report also announces that, for the first time, the prospect of a microbicide that contains antiretroviral medicine is providing additional hope to the women in sub-Saharan Africa, who continue to bear a disproportionate burden of the HIV epidemic in this region.

Days later, the Obama administration announces new goals for PEPFAR (the President’s Emergency Plan for AIDS Relief), saying it is “the beginning of the end of AIDS.”

“Today is a remarkable day,” President Barack Obama says in a White House statement.  “Today, we come together, as a global community, across continents, faiths and cultures, to renew our commitment to ending the AIDS pandemic – once and for all.”

December 23, 2011
Science Journal Announces ‘Breakthrough of the Year’

The journal Science announces that it has chosen the HPTN 052 study as its 2011 Breakthrough of the Year.

March 13, 2012
Researchers Link ART Therapy to Cardiovascular Disease

A new study suggests that people living with HIV and taking antiretroviral therapy (ART) have an increased risk of cardiovascular disease.

Learn More.

Researchers from the University of New South Wales in Australia release the results of a study that show that people living with HIV who are taking antiretroviral therapy (ART) have an increased risk of cardiovascular disease.

“Although the health and survival of PLHIV have improved with effective ARTs, people living with HIV are at substantially greater risk of developing other comorbidities, such as cardiovascular disease, compared with uninfected people,” the researchers conclude.

Due to the prevelance of cardiovascular disease and its cause of deaths worldwide, this poses a significant issue for people living with HIV, particularly as they get older, according to the researchers.

July 3, 2012
FDA Approves First At-Home Test

The FDA approves the first at-home HIV test that will let users learn their HIV status right away.

July 16, 2012
Truvada for PrEP Approved

The FDA approves the use of Truvada® for pre-exposure prophylaxis (PrEP). Adults who do not have HIV, but who are at risk for infection, can now take this medication to reduce their risk of getting the virus through sexual activity.

March 4, 2013
Case Reported of HIV-Infected Child ‘Functionally Cured’

NIH-funded scientists announce the first well-documented case of an HIV-infected child, designated as “the Mississippi Baby,” who appears to have been functionally cured of HIV infection (i.e., no detectable levels of virus or signs of disease, even without antiretroviral therapy.

June 2, 2013
NY Times Addresses Middle-Aged People Living With HIV

The New York Times runs two articles which focus on middle-aged people living with HIV: The Faces of H.I.V. in New York in 2013 and ‘People Think It’s Over’: Spared Death, Aging People With H.I.V. Struggle to Live

June 5, 2013
NMAC Issues Plan on Mitigating the Impact of HIV on Black Men

The National Minority AIDS Council (NMAC) releases RISE Proud: Combating HIV Among Black Gay and Bisexual Men, an action plan to mitigate the impact of HIV on black gay and bisexual men.

July 2, 2013
Bone Marrow Transplant Recipients Reportedly Cured of HIV

Researchers report that two HIV-positive patients in Boston who had bone-marrow transplants for blood cancers have apparently been virus-free for weeks since their antiretroviral drugs were stopped

January 2, 2014
‘Cured’ HIV Cancer Patients Relapse

News sources report that the two Boston patients believed to have been cured of HIV after undergoing treatment for cancer have relapsed

February 3, 2014
amfAR Launches $100 Million Research Initiative

amfAR announces the launch of Countdown to a Cure for AIDS, a $100 million research initiative aimed at finding a broadly applicable cure for HIV by 2020.

March 4, 2014
Initial Research Supports ‘Undetectable = Untransmittable’ Concept

European researchers announce the results of the first phase of the PARTNER Study, an observational study focusing on the risk of sexual HIV transmission when an HIV-positive person is on treatment.

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The study found that no HIV-positive partner who was undergoing antiretroviral therapy and had an undetectable viral load had transmitted HIV.

July 10, 2014
‘Mississippi Baby’ No Longer Undetectable

The National Institutes of Health announce that the “Mississippi baby” now has detectable levels of HIV after more than two years of showing no evidence of the virus.

January 8, 2015
Injectable Contraceptive May Increase Women’s Risk of HIV

A review of multiple studies of South African women indicates that using Depo Provera, an injectable contraceptive, may increase women’s chances of contracting HIV by 40 percent.

February 23, 2015
CDC: More Than 90% of New Infections Preventable

CDC announces that more than 90% of new HIV infections in the U.S could be prevented by diagnosing people living with HIV and ensuring they receive prompt, ongoing care and treatment.

Learn More.

Published by the CDC and subsequently in JAMA, the American Medical Association’s journal, a report by Jacek Skarbinski, M.D., and Eli Rosenberg, M.D. announces that persons living with HIV who are retained in care and have achieved viral suppression are 94.0% less likely to transmit HIV than HIV-infected undiagnosed persons.

“Unfortunately, too few persons living with HIV have achieved viral suppression,” the report concludes. “These estimates of the relative number of transmissions from persons along the HIV care continuum highlight the community-wide prevention benefits of expanding HIV diagnosis and treatment in the United States.”

The report recommends the implementation of improvements at each step of the continuum to reduce HIV transmission.

“Through stronger coordination of efforts among individuals, HIV care providers, health departments, and government agencies, the United States can realize meaningful gains in the number of persons living with HIV who are aware of their status, linked to and retained in care, receiving ART, and adherent to treatment,” state the researchers.

February 25, 2015
HIV Outbreak in Indiana Tied to Injection Drug Use

Indiana state health officials announce an HIV outbreak linked to injection drug use in the southeastern portion of the state. By the end of the year, Indiana will confirm 184 new cases of HIV linked to the outbreak.

April 15, 2015
NIH Launches Study of Heart Disease Among HIV+

NIH launches a large, multicenter, international clinical trial to study heart disease in people living with HIV, who are up to twice as likely as HIV-negative individuals to have heart attacks and other forms of cardiovascular disease.

May 27, 2015
START Study Shows Reduced Risk of AIDS

Results from the Strategic Timing of AntiRetroviral Treatment (START) study indicate that HIV-positive individuals who start taking antiretroviral drugs before their CD4+ cell counts decrease have a considerably lower risk of developing AIDS or other serious illnesses.

Learn More.

Subsequent data releases show that early therapy for people living with HIV also prevents the onset of cancer, cardiovascular disease, and other non-AIDS-related diseases.

June 30, 2015
Cuba Eliminates Mother-to-Child HIV Transmission

The World Health Organization certifies that Cuba is the first nation to eliminate mother-to-child transmission of both HIV and syphilis.

July 20, 2015
Study Shows Effectiveness of Antiretrovirals in Preventing Transmission

Researchers report that antiretroviral therapy is highly effective at preventing sexual transmission of HIV from a person living with HIV to an uninfected heterosexual partner, when the HIV-positive partner is virally suppressed. The finding comes from the decade-long HPTN 052 clinical trial.

July 23, 2015
FDA Approves Test Differentiating Between HIV-1 & HIV-2

The U.S. Food and Drug Administration approves the first diagnostic test that differentiates between different types of HIV infections (HIV-1 and HIV-2). The test can also differentiate between acute and established HIV infections.

January 28, 2016
Researchers Report Increasing Resistance to Tenofovir

Researchers announce that an international study of over 1,900 patients with HIV who failed to respond to the antiretroviral drug tenofovir—a key HIV treatment medication—indicates that HIV resistance to the medication is becoming increasingly common.

February 25, 2016
First Report of HIV Infection Despite Truvada

At the annual Conference on Retroviruses and Opportunistic Infections (CROI), researchers report that a man taking the HIV-prevention pill Truvada® has contracted HIV—marking the first reported infection of someone regularly taking the drug.

March 3, 2016
Researchers Report Gender Differences in Truvada Dosage

Pharmacy researchers report finding that women need daily doses of the antiviral medication Truvada® to prevent HIV infection, while men only need two doses per week due to differences in the way the drug accumulates in vaginal, cervical and rectal tissue.

May 12, 2016
NIH Announces HIV Vaccine Trial in South Africa

The National Institutes of Health and partners announce they will launch a large HIV vaccine trial in South Africa in November 2016, pending regulatory approval. This represents the first time since 2009 that the scientific community has embarked on an HIV vaccine clinical trial of this size.

January 14, 2017
Gates Foundation Invests in HIV-Prevention Implants

The Bill and Melinda Gates Foundation announces the investment of $140 million in a new HIV-prevention tool, implants that can deliver HIV-prevention medication continuously over a long period of time.

Learn More.

Eliminating the need for people to take preexposure prophylaxis (PrEP) medication on a daily basis, the HIV-preventing drug implants could be used to deliver a consistent supply of drugs, aiding people vulnerable to HIV.

“There’s a vital need for an HIV/AIDS intervention that allows those at risk to incorporate prevention more easily into their daily lives,” said Sue Desmond-Hellmann, CEO of the Bill & Melinda Gates Foundation.

January 24, 2018
NIH Launches Study of Antiretrovirals & Pregnant Women

The National Institutes of Health launches a large international study to compare the safety and efficacy of antiretroviral treatment regimens for pregnant women living with HIV and their infants.

Learn More.

It will provide data on the use of newer HIV medications during pregnancy, helping to ensure that women living with HIV and their infants receive the best available treatments.

May 3, 2018
New Study: ART Key to Healthy Brain

An international research team finds that early antiretroviral therapy is key to avoiding brain atrophy for people living with HIV.

Learn More.

Researchers from the Montreal Neurological Institute and Hospital (The Neuro) of McGill University, in collaboration with researchers from University of Washington St. Louis and Yale University, analysed magnetic resonance imaging data from 65 patients at the University of California San Francisco who had been infected less than one year before.  Assessment of the MRI data found that the longer people living with HIV went without treatment, the greater the atrophy in several brain regions.

Once patients began antiretroviral therapy, the atrophy stopped and some brain volume was even restored.  These results underscored the need for early detection of HIV and delivery of ART as soon as possible to avoid neurological damage.

June 11, 2018
Early Antiretroviral Therapy Linked to Cancer Prevention

In the first study to focus specifically on the effect of viral suppression on cancer risk, researchers find that early, sustained ART helps to prevent cancers in people living with HIV.

Learn More.

The research shows that early and sustained ART reduces the onset of AIDS-defining cancers and — to a lesser degree — other cancers in HIV-positive people.

But the long-term study, which followed nearly 150,000 veterans over the years of 1999-2015, also found that the cancer risk for HIV-positive patients with long-term viral suppression still was greater than the risk of cancer for HIV-negative patients.

July 18, 2018
Studies Show HIV-Positive People Suffer from Heart Disease at 2x Rate

A global analysis finds that people living with HIV are twice as likely as their HIV-negative counterparts to suffer from heart disease.

Learn More.

Based on a review of studies with almost 800,000 people from 153 countries, an international team of experts finds that HIV-associated cardiovascular disease has more than tripled in the past 20 years as more people live longer with the virus.

The greatest impact is in sub-Saharan Africa and Asia Pacific regions, with Swaziland, Botswana and Lesotho particularly affected.

Researchers say the findings will help to target treatments to people facing the greatest risk, helping to maximize resources in countries with limited healthcare funding.

August 1, 2018
Computer Simulation Predicts Transmission Patterns Across Populations

Researchers at Los Alamos National Laboratory demonstrate that computer simulations can accurately predict the transmission of HIV across populations.

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The simulations are consistent with 840,000 actual HIV DNA sequences contained in a global public HIV database, according to the study published in Nature Microbiology.

The simulations could allow state health departments to track the spread of HIV and provide a powerful new tool to help prevent new HIV infections.

“We looked for special genetic patterns that we had seen in the simulations, and we can confirm that these patterns also hold for real data covering the entire epidemic,” said Thomas Leitner, a computational biologist at Los Alamos and lead author of the study.

HIV is particularly interesting to study in this manner, Leitner noted, as the virus mutates rapidly and constantly within each infected individual.  The changing “genetic signatures” of its code provide a path that researchers can follow in determining the origin and time frame of an infection, and the computer simulations are now proven to be successful in tracking and predicting the virus’s movements through populations.

September 28, 2018
Thai Study Confirms Accuracy of U=U Message

A study of MSM in Thailand finds that having a sexually transmitted infection does not affect the ability of people living with HIV to achieve and maintain an undetectable viral load, confirming that “Undetectable = Untransmittable.”

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Months earlier, UNAIDS launched its “Undetectable = Untransmittable” (or U=U) campaign to spread the message that people living with HIV with an undetectable viral load cannot transmit HIV sexually.

UNAIDS’s campaign is supported by the results of three large studies of sexual HIV transmission among thousands of couples, one partner of which was living with HIV and the other was not, were undertaken between 2007 and 2016. In those studies, there was not a single case of sexual transmission of HIV from a virally suppressed person living with HIV to their HIV-negative partner.


October 17, 2018
Australian Study Links Diagnosis Reduction to PrEP

A research study finds that a targeted, high-coverage roll-out of PrEP (pre-exposure prophylaxis) is associated with a 25% reduction in new HIV diagnoses in one year.

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The study followed 3,700 MSM in New South Wales, Australia, who were taking PrEP with high levels of adherence.

As the first empirical study to test PrEP’s population-level effectiveness, the program found that HIV infections declined in the study cohort and also statewide in Australia’s most populous state, New South Wales.

The report concludes that rapid, targeted, high-coverage PrEP implementation is effective to reduce new HIV infections at the population level.

Less than a year later, Andrew Grulich, MD, head of the HIV Epidemiology and Prevention Program at the Kirby Institute at UNSW Sydney, would present follow-up data supporting the initial study at the 10th International AIDS Society Conference on HIV Science in Mexico City.


NIH Develops Tool to Measure HIV Cure Strategies

Scientists funded by the National Institutes of Health develop a tool to measure the success of HIV cure strategies.

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The tool accurately and easily counts the cells that make up the HIV reservoir, the stubborn obstacle to an HIV cure. This advance enables researchers who are trying to eliminate the HIV reservoir to clearly understand whether their strategies are working.

February 7, 2019
PrEP & Vaginal Ring Considered for Girls in Southern Africa

In a response to rising rates of infection among adolescent girls and young women in sub-Saharan Africa, the National Institutes of Health announces the launch of a clinical trial with girls and young women aged 16–21 at five sites in Kenya, South Africa, Uganda and Zimbabwe

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The research project seeks to examine the safety and use of two HIV prevention tools — PrEP and a vaginal ring — for young women and girls under the title “REACH” (Reversing the Epidemic in Africa with Choices in HIV prevention).

One in four new infections in sub-Saharan Africa were women and girls aged 15-24 – despite making up 10% of the population.

“Women in less-developed countries disproportionately bear the burden in terms of ill health when facing food insecurity or a shock or disaster like drought that impacts the ability to get food or harvest food,” said Kelly Austin, associate professor of sociology at Lehigh University.

Essentially, lack of resources can lead to sexual assault, marriages of economic necessity and the resultant transmission of HIV.

Conducted for 1.5 years, the study would go on to show that the vast majority (97%) of the 247 participants used the vaginal ring and daily oral PrEP some or all of the time.  Fewer than 3% of participants would use neither of the products, according to laboratory tests for adherence.

“In many ways, these results exceeded even our own expectations, yet at the same time, it’s not surprising to find that these young women have the capacity and desire to protect themselves against HIV,” explains Gonasagrie (Lulu) Nair, MBChB, MPH, REACH protocol chair, Centre for Medical Ethics and Law, Faculty of Medicine, at Stellenbosch University in South Africa.  “They simply need to feel empowered and have the agency to make choices based on what they feel is right for them.”


March 4, 2019
‘London Patient’ Reportedly Second to be Cured of HIV

At the 2019 Conference on Retroviruses and Opportunistic Infections in Seattle, researchers announce the second cure of a person with HIV.

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According to the case report published in Nature, an HIV patient in London has successfully received stem cell transplants of CCR5-delta 32, a rare genetic mutation that appears to make a small number of people resistant to HIV by preventing the virus from attacking the immune system.

The patient was diagnosed with non-Hodgkin’s lymphoma in 2012, which led his doctors to suggest gene therapy to create healthy blood cells. Since receiving the treatment, he has stopped taking antiretroviral medications and his body has reportedly been free of the virus for the past 18 months.

The patient, who is not named, is the second person to have successfully received such treatment. The first was Timothy Brown, a.k.a. the “Berlin Patient,” who made headlines in 2008 when he received a similar bone marrow transplant.

March 25, 2019
HIV-to-HIV Kidney Transplant Performed Successfully

Surgeons at Johns Hopkins Medical Center, perform the first living donor HIV-to-HIV kidney transplant in the U.S.  The ability to use organs from living HIV-positive individuals could increase the supply available for transplant.

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Nina Martinez, 35, is the living donor. She donated her kidney to an anonymous recipient after the friend she had hoped to give it to died last fall. Martinez acquired HIV when she was 6 weeks old through a blood transfusion and was diagnosed at age 8.

“I wanted to show that people living with HIV were just as healthy.” Martinez says in a news conference held to announce the medical break-through. “Someone needed that kidney, even if it was a kidney with HIV. I very simply wanted to show that I was just like anybody else.”

Martinez first learned of the opportunity for her to donate a kidney in 2013, when the HIV Organ Policy Equity Act (HOPE Act) passed in Congress.  Yet, until she saw a storyline on the medical drama Grey’s Anatomy a few months later, she didn’t realize where her own life would intersect with kidney donation.

The HOPE Act was introduced on February 14, 2013, in the Senate by Sens. Barbara Boxer (D-CA), Tammy Baldwin (D-WI), Tom Coburn (R-OK), and Rand Paul (R-KY) and in the House by Rep. Lois Capps (D-CA).  The Senate passed the legislation by unanimous consent, and about six months later, the House passed it by unanimous consent.

The doctors at Johns Hopkins say the recipient is doing well.

“This is the first time someone living with HIV has been allowed to donate a kidney, ever, in the nation, and that’s huge,” says Dorry Segev, M.D., Ph.D., professor of surgery at Johns Hopkins.  “A disease that was a death sentence in the 1980s has become one so well-controlled that those living with HIV can now save lives with kidney donation — that’s incredible.”


May 19, 2019
NIH Evaluates Antiretroviral Therapy for HIV Suppression

A clinical trial is launched to evaluate long-acting ART (antiretroviral therapy) for maintaining HIV suppression in people who find it a challenge to take a daily medication.

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The National Institutes of Health study, called Long-Acting Therapy to Improve Treatment Success in Daily Life (LATITUDE), will help determine whether a combination of two experimental injectable formulations of ART are better than conventional daily medications in managing HIV infection in certain populations.

The purpose of this study, supported by funding is to compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection: long-acting antiretroviral therapy (ART) and all-oral standard of care (SOC).

LATITUDE seeks to enroll approximately 350 volunteers with documented treatment lapses within the past 18 months. All study participants will begin a daily oral ART regimen and individualized adherence and retention support. Volunteers who become virally suppressed by week 24 will then be randomized to either continue standard-of-care therapy for one year or begin an oral regimen consisting of RPV and CAB for 4 weeks, followed by long-acting injectable formulations of those drugs every 4 weeks for 48 weeks.

After this 52-week period, participants originally randomized to the standard-of-care arm may cross over to long-acting therapy, and participants originally randomized to the long-acting therapy arm may remain on that regimen for an additional year.

The University of California San Francisco HIV/Aids Center and the University of California Los Angeles CARE Center are two of many research institutions participating in this study.

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