HIV and AIDS
Human Immunodeficiency Virus and
Acquired Immunodeficiency Syndrome

HIV/AIDS Historical Time Line

1981-1990

AIDS identified as being caused by a human retrovirus, Human Immunodeficiency Virus (HIV).

FDA approved first enzyme linked immunosorbant assay (ELISA) test kit to screen for antibodies to HIV.

On March 19, FDA approved AZT - the first drug approved for the treatment of AIDS.
On April 29, FDA approved the first Western blot blood test kit - a more specific test.
On August 18, FDA sanctioned the first human testing of a candidate vaccine against HIV.
FDA Published regulations which require screening all blood and plasma collected in the U.S. for HIV antibodies.
FDA completed studies demonstrating the safety of immune globulin products. The efficacy of viral inactivation and partitioning during manufacturing procedures was confirmed.
FDA revised its strategy for the regulation of condoms by strengthening its inspection of condom manufacturers and repackers, strengthening its sampling and testing of domestic and imported condoms in commercial distribution, and providing guidance on labeling of condoms for the prevention of AIDS.

On February 12, Trimetrexate was the first AIDS drug to be granted pre-approval distribution status under the new Treatment IND regulations. Trimetrexate was used to treat Pneumocystis carinii pneumonia in AIDS patients who can not tolerate standard forms of treatment.
On November 21, FDA licensed Intron A and Roferon A (human interferon alpha injection) for the treatment of Kaposi's Sarcoma, a cancer resulting from HIV.
On November 28, FDA authorized pre-approval distribution of ganciclovir under a treatment IND protocol for the treatment of cytomegalovirus retinitis in AIDS patients.
FDA doubled blood facility inspection effort with the inspection of 100 percent of FDA-regulated blood and plasma donor facilities.
FDA implemented new regulations designed to make promising therapies available sooner. Subpart E of the IND regulations was establish procedures designed to expedite development, evaluation, and marketing of new therapies intended to treat patients with life-threatening and severely-debilitating diseases.

On February 3, FDA authorized pre-approval distribution of aerosolized pentamidine under a treatment IND protocol for the prevention of Pneumocystis carinii pneumonia.
On June 15, FDA approved NebuPent (aerosolized pentamidine) for the prevention of Pneumocystis carinii pneumonia.
On June 23, FDA approved Cytovene (ganciclovir) infusion for use in the treatment of cytomegalovirus retinal infections in persons with AIDS.
On June 27, FDA authorized pre-approval distribution of erythropoietin (EPO) under a treatment IND protocol for the treatment of zidovudine (AZT) related anemia in HIV positive patients.
On September 28, FDA approved Retrovir (zidovudine, AZT) in syrup formulation.
On September 28, FDA authorized pre-approval distribution of dideoxyinosine (ddI) under a treatment IND protocol for the treatment of patients with AIDS or AIDS Related Complex who are intolerant to zidovudine (AZT).
FDA licensed the first diagnostic kit to detect the presence of HIV-1 by directly detecting the proteins, or antigens, of the virus.
FDA participated in the establishment of an AIDS Clinical Trial Information Service (ACTIS), a computerized listing of information on AIDS-related clinical trials available via toll free telephone service.
On October 26, FDA authorized pre-approval distribution of Retrovir (zidovudine, AZT) under a treatment IND protocol for the treatment of pediatric patients with HIV disease.

On January 29, FDA approved Diflucan (fluconazole) tablets to treat two serious AIDS-related fungal infections (Cryptococcal meningitis and candidiasis).
On February 2, FDA approved Retrovir (zidovudine, AZT) in an intravenous dosage form.
Expanded labeling for Retrovir (zidovudine, AZT) was approved, including dosage (January 1990), for use in early HIV disease (March 1990), and for use with children (May 1990).
On December 31, FDA approved Epogen (erythropoietin, EPO) for the treatment of zidovudine-related anemia.
FDA granted a license for the Recombigen HIV-1 EIA HIV antibody detection kit, designed for high volume screening sites.
FDA approved Novopath HIV-1 Immunoblot test for the detection of antibodies to individual proteins of HIV-1. This test is nearly 5 times faster than comparable tests using the same technology.
On December 12, FDA published a final rule defining acceptable quality levels for medical gloves and establishing the sampling plans and test methods that FDA will use to determine whether gloves are adulterated.

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