HIV
and AIDS
Human Immunodeficiency Virus and
Acquired Immunodeficiency Syndrome
HIV/AIDS Historical Time Line
1981-1990
1981
1982
- FDA received first IND submission for treatment of AIDS.
1984
- AIDS identified as being caused by a human retrovirus,
Human Immunodeficiency Virus (HIV).
1985
- FDA approved first enzyme linked immunosorbant assay (ELISA) test
kit to screen for antibodies to HIV.
1987
- 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.
1988
- 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.
1989
- 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.
1990
- 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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