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  U.S. Department of Health and Human Services | National Institutes of Health

HIV/AIDS

Human Immunodeficiency Virus (HIV) is a virus that attacks the body’s immune system. If HIV is not treated, it can lead to Acquired Immunodeficiency Syndrome (AIDS). There is currently no cure for HIV, but with proper medical care, it can be controlled, and people can still live long, healthy lives.

HIV infections came from chimpanzees in Central Africa. The chimpanzee version of the virus (called simian immunodeficiency virus, or SIV) was probably passed to humans when humans hunted these chimpanzees for meat and came into contact with their infected blood. Studies show that HIV may have jumped from chimpanzees to humans as far back as the late 1800s. Over the decades, HIV slowly spread across Africa and into other parts of the world. The virus has existed in the United States since at least the mid-to-late-1970s.

Symptoms of HIV include fever, chills, rash, night sweats, muscle aches, sore throat, fatigue, swollen lymph nodes, and mouth ulcers. AIDS is the most severe phase of an HIV infection. People receive an AIDS diagnosis when their CD4 cell count drops below 200 cells/mm or if they develop certain opportunistic infections. People with AIDS have significantly damaged immune systems, making them susceptible to many severe illnesses, called opportunistic infections. Without treatment, people with AIDS typically survive about three years.

During the emerging AIDS epidemic in the early 1980s, Dr. Ruth Kirschstein, who worked for many years in biologics but was at this time was the Director of the National Institute of General Medical Sciences (NIGMS), helped to mobilize the National Institutes of Health (NIH) efforts to study the virus and develop and test drugs to combat this new public health threat in spite of political opposition. 

Additionally, early biologics research on AIDS was carried out in Building 29A in the Division of Virology. The individuals involved in this early research include Drs. Lewellys F. Barker, Gerald V. Quinnan, Jr., Kathryn Zoon, and Jay Epstein.

Dr. Robert C. Gallo of the National Cancer Institute. Gallo is a biomedical researcher and known for his research on the Human Immunodeficiency Virus (HIV) and continues to work on HIV/AIDS research.  Office of NIH History & Stetten Museum
Both the NIH and the Food and Drug Administration (FDA) were and still are actively involved in research and regulation to prevent the spread of HIV and AIDS. In addition to individual antiretroviral drugs, preventive medications, fixed dose combination drugs, and monoclonal antibodies have revolutionized the fight against the AIDS epidemic. In the past 30 years, the FDA has approved 32 antiretroviral drugs, one pharmacokinetic enhancer, and 21 fixed dose combinations to treat HIV/AIDS patients. Thanks to these therapeutic advancements life expectancy for AIDS patients has increased dramatically. Early research began at the NIH in the National Cancer Institute (NCI) and the National Institute of Allergy and Infectious Diseases (NIAID). As the HIV pandemic spread and given the fact that so many physiological systems were involved in HIV/AIDS infections, increased coordination across the NIH campus was needed. The Office of AIDS Research (OAR) was established in1988 for this purpose and still exists today.

Dr. H. Clifford Lane (left), one of the first investigators to study immunopathogenic mechanisms of HIV disease, and Dr. Anthony Fauci (right), who has made influential contributions to the understanding of how HIV destroys the body's defenses leading to the progression to AIDS.  Office of NIH History & Stetten Museum

Drs. Thomas Folks and Guide Poli in their laboratory for AIDS research at the National Institute of Allergy and Infectious Diseases (NIAID).  Office of NIH History & Stetten Museum


AIDS/HIV Research, Testing, Therapeutics, Policy at FDA

In the early years of the AIDS epidemic, when the pathological signs were understood and the sudden growth of cases were documented while the etiology remained unclear, the Office of Biologics Research and Review (as the principal functions of the FDA Bureau of Biologics were renamed when the drugs and biologics functions were combined under the Center for Drug and Biologics from 1982 to 1987) and other components of the Public Health Service were gathered to understand and combat this outbreak. The Office of Biologics Research and Review (OBRR) investigated the virology and immunology of the syndrome, how it affected various biological products, and staff screened new biologics that might be brought to bear against AIDS. For example, the observation that AIDS patients could not manufacture the necessary T-cell response to address one common opportunistic infection—from cytomegalovirus, suggested (based in part on in vitro tests) that interleukin-2 deficiency could be behind the syndrome.  FDA and NIH collaborated on a phase 1 study in this regard. 

As the clinical trials involving IL-2 progressed through 1983, OBRR continued its collaborations on other lymphokines in AIDS patients. For example, lymphoblastoid interferon yielded some benefit in Kaposi’s sarcoma, a systemic cancer primarily affecting those with AIDS, but has done little to alter the immunodeficiency or the course of the virus. Gamma interferon fared likewise. Preliminary results with IL-2 revealed some effect on immunity.  

Assessing the impact of the epidemic on the blood supply and how to mitigate risk was the subject of many workshops and meetings that the Office participated in with the Departmental Task Force, industry, patient groups such as the National Hemophilia Foundation and the National Gay Task Force, blood collection organizations such as the American Association of Blood Banks and the American Red Cross, academe, the agency’s Blood Products Advisory Committee, and others.

On March 4, 1985, HHS Secretary Margaret Heckler announced that FDA had licensed the first test to detect exposure to the virus responsible for AIDS. The virus, known then in the U. S. as HTLV-III, had been identified and isolated in September 1984. The licensee, Abbott Laboratories, soon distributed the test to more than 2000 blood banks and plasma centers, as well as other laboratories serving clinics and physicians.

a plastic box with foam holding vials for an HIV test kid that was approved in 1985

FDA approved the first HIV test kit in March 1985



FDA History Office


OBRR licensed the Western Blot test to screen blood and validate previous tests for antibodies to the AIDS virus on 30 April 1987. This approval provides increased accuracy in testing blood.  A combination test the detected antibodies to both HIV-1 and the much less common AIDS virus, HIV-2, was licensed in 1991. CBER had licensed a test for the latter virus the prior year, but many blood banks did not test for that virus given its very low frequency.  FDA believed a combination test would be embraced more widely and lessen the risk of HIV transmission through the blood supply.

In 1988, CBER licensed a rapid screening test for AIDS that can be done without sophisticated equipment. Employing genetically engineered proteins and microscopic latex beads, the latex agglutination test could be performed in five minutes. However, this was not intended to replace tests used by blood banks and clinics, but it was expected to serve as a preliminary test where the results could be interpreted by a medical professional.

Also in 1988, CBER licensed alpha interferon for the treatment of Kaposi’s sarcoma. Multiple studies at NIAID and elsewhere indicated that up to about 50 percent of the patients in earlier stages of AIDS saw significant reduction of tumor sizes with high doses of interferon.

Though not suitable for application in blood collection and processing facilities, CBER licensed the first clinical diagnostic test for direct detection of the HIV virus in 1989. Previous tests operated on the basis of indirect detection, based on an antibody response. The new test, HIVAG-1, detected HIV antigens in the patient’s serum or plasma, and it was expected to help physicians track the progress of their AIDS patients.

a photo from 1992 of a man and a woman with shovels under a tent for a groundbreaking ceremony for NIH Building 29B. Another man is to the right but half cut out of the photo

FDA Commissioner Dr. David Kessler, at left, with Associate Commissioner Sharon Holston at the 1992 groundbreaking ceremony for Building 29B, an AIDS research facility.  FDA History Office


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