History

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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Sources:

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

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.

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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Sources:

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

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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Sources:

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

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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Sources:

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

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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Sources:

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)”

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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Sources:

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

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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Source:

www.HIV.gov, “A Timeline of HIV/AIDS”

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.

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Sources:

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

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.

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Source:

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

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.

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Sources:

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

“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.

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Source:

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

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.

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Source:

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

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.”

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Source:

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

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.

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Source:

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.

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Source:

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.”

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.

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.

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.

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.

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.

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.

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.”

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.

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.

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.”

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.

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.

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.

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.

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.

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.”

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.

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.

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.

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.”

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.

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.

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.”

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.

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

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.

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.

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.

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.

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.

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.

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.

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.