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.
Office of NIH History & Stetten Museum
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.
Office of NIH History & Stetten Museum
Office of NIH History & Stetten Museum
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.
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.
FDA History Office
More Information:
- Progress Against AIDS Timeline
- NIAID History of AIDS Research Timeline
- FDA History page on AIDS
- Office of NIH History & Stetten Museum’s In Their Own Words exhibition.