The History of AIDS: Timeline of the History of HIV/AIDS: 1988 - 1990
A Chronology of Significant Events
(as of 4/20/05)
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.
November 28, FDA authorized pre-approval distribution of ganciclovir under a treatment
IND protocol for the treatment of cytomegalovirus retinitis in AIDS patients.
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.
FDA doubled blood facility inspection effort with the inspection of 100 percent of
FDA-regulated blood and plasma donor facilities.
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 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).
On September 28, FDA approved Retrovir (zidovudine, AZT) in syrup formulation.
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.
FDA licensed the first diagnostic kit to detect the presence of HIV-1 by directly
detecting the proteins, or antigens, of the virus.
On October 26, FDA authorized pre-approval distribution of Retrovir (zidovudine,
AZT) under a treatment IND protocol for the treatment of pediatric patients with
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
On December 31, FDA approved Epogen (erythropoietin, EPO) for the treatment of zidovudine-related
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.
1981 - 1987 ...Last ||| Next... 1991 - 1992
The History of AIDS © 2005
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