Zidovudine (INN) or azidothymidine (AZT) (also called ZDV) is an antiretroviral drug, the first one approved for treatment of HIV. It is also sold under the names Retrovir® and Retrovis®, and as an ingredient in Combivir® and Trizivir®. It is an analog of thymidine.

History

---

Zidovudine was the first drug approved for the treatment of AIDS and HIV infection. Jerome Horwitz first synthesized AZT in 1964, under a US National Institutes of Health (NIH) grant. It was originally intended to treat cancer, but failed to show efficacy and had an unacceptably high side effect profile. The drug then faded from view until February 1985, when Samuel Broder, Hiroaki Mitsuya, and Robert Yarchoan, three scientists in the National Cancer Institute (NCI), collaborating with Janet Rideout and several other scientists in Burroughs Wellcome Co., started working on it as an AIDS drug. After showing that this drug was an effective agent against HIV in vitro, the team conducted the initial clinical trial that provided evidence that it could increase CD4 counts in AIDS patients. - describing AZT development - describing AZT development

A placebo-controlled randomized trial of AZT was subsequently conducted by Burroughs-Wellcome (now GlaxoSmithKline), in which it was shown that it could prolong the life of patients with AIDS. Burroughs Wellcome Co. filed for a patent on AZT in 1986. The Food and Drug Administration (FDA) approved the drug (via the then-new FDA accelerated approval system) for use against HIV, AIDS, and AIDS Related Complex (ARC, a now-defunct medical term for pre-AIDS illness) on March 20, 1987, and then as a preventive treatment in 1990. It was initially administered in much higher dosages than today, typically one 400mg dose every four hours (even at night). However, the unavailability at that time of alternatives to treat AIDS affected the risk/benefit ratio, with the certain toxicity of HIV infection outweighing the risk of drug toxicity. One of AZT's side effects includes anemia, a common complaint in early trials.

More on [ Zidovudine ]

CFDA: FDA Latest Computer Systems Warning Letters

WL Issued to Amrex Zetron Inc
FDA Tue, 14 Apr 2009 00:00:00 -0400
FDA Warning Letter Issued to Amrex Zetron Inc on 14 Apr 2009 by Los Angeles District Office
WL Issued to Coast Institutional Review Board
FDA Tue, 14 Apr 2009 00:00:00 -0400
FDA Warning Letter Issued to Coast Institutional Review Board on 14 Apr 2009 by Center for Drug Evaluation and Research
WL Issued to Branitz, Bruce, MD
FDA Thu, 09 Apr 2009 00:00:00 -0400
FDA Warning Letter Issued to Branitz, Bruce, MD on 09 Apr 2009 by Center for Drug Evaluation and Research
WL Issued to Cote, Charles J., MD
FDA Mon, 02 Mar 2009 00:00:00 -0400
FDA Warning Letter Issued to Cote, Charles J., MD on 02 Mar 2009 by Center for Drug Evaluation and Research
WL Issued to Genzyme Corporation
FDA Fri, 27 Feb 2009 00:00:00 -0400
FDA Warning Letter Issued to Genzyme Corporation on 27 Feb 2009 by New England District Office
WL Issued to Hammill Manufacturing Company
FDA Tue, 06 Jan 2009 00:00:00 -0400
FDA Warning Letter Issued to Hammill Manufacturing Company on 06 Jan 2009 by Cincinnati District Office

CFDA: FDA Latest Drug GCP Warning Letters

WL Issued to Coast Institutional Review Board
FDA Tue, 14 Apr 2009 00:00:00 -0400
FDA Warning Letter Issued to Coast Institutional Review Board on 14 Apr 2009 by Center for Drug Evaluation and Research
WL Issued to Branitz, Bruce, MD
FDA Thu, 09 Apr 2009 00:00:00 -0400
FDA Warning Letter Issued to Branitz, Bruce, MD on 09 Apr 2009 by Center for Drug Evaluation and Research
WL Issued to Bukowski, Ronald M, MD
FDA Mon, 30 Mar 2009 00:00:00 -0400
FDA Warning Letter Issued to Bukowski, Ronald M, MD on 30 Mar 2009 by Center for Drug Evaluation and Research
WL Issued to Youabian, Inc
FDA Tue, 17 Mar 2009 00:00:00 -0400
FDA Warning Letter Issued to Youabian, Inc on 17 Mar 2009 by Los Angeles District Office
WL Issued to Provena St. Joseph's Medical Center IRB
FDA Thu, 12 Mar 2009 00:00:00 -0400
FDA Warning Letter Issued to Provena St. Joseph's Medical Center IRB on 12 Mar 2009 by Center for Biologics Evaluation and Research
WL Issued to Paulson, Daniel M., MD
FDA Wed, 11 Mar 2009 00:00:00 -0400
FDA Warning Letter Issued to Paulson, Daniel M., MD on 11 Mar 2009 by Center for Drug Evaluation and Research

Subscribe to Drugs_and_Medications RSS feed