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AZT EFFICACY SHOWN FOR EARLY SYMPTOMATIC HIV INFECTION

Executive Summary

AZT EFFICACY SHOWN FOR EARLY SYMPTOMATIC HIV INFECTION in a double-blind placebo-controlled trial in 713 HIV-infected persons. The National Institute of Allergy and Infectious Diseases announced results of the trial in an Aug. 3 press release. Of 713 study participants, NIAID reported, those progressing to advanced ARC or AIDS, as of July, totaled 50 -- 36 from the placebo group and 14 in the AZT treatment group. Commenting on the results, NIAID Director Anthony Fauci stated: "For the first time, the benefits of anti-retroviral treatment for patients with early symptomatic HIV infection have been clearly shown. In this study, significantly fewer persons receiving zidovudine progressed to advanced ARC or AIDS." "Only in those participants who had T4 cell counts between 200 and 500 when they entered the study," did AZT (Burroughs Wellcome's Retrovir) have a beneficial effect, NIAID noted. Serious side effects were observed in fewer than 5% of participants. FDA Commissioner Young stated in the release that FDA "will work closely with the NIAID and Burroughs Wellcome Co. to translate these important results into wider availability of zidovudine to this category of symptomatic HIV-infected persons." Burroughs Wellcome must submit a supplemental NDA for approval to market the drug to patients with early symptoms of HIV, which NIAID estimates at 100,000 to 200,000 people. The company said it has no timetable for submission of the supplemental application. The trial was conducted at 29 units of NIAID's AIDS Clinical Trials Group (ACTG) and coordinated by Margaret Fischl, MD, University of Miami. Begun in August 1987, the trial involved HIV-infected persons with T4 cell levels between 200 and 800/mm and one or two HIV-associated symptoms, such as oral thrush, chronic rash, or intermittent diarrhea. Study participants received either placebo or 200 mg AZT every four hours for three to 20 months. The Data and Safety Monitoring Board of the ACTG, which reviews the trial data at six month intervals, decided to halt the trial at its Aug. 2 meeting. NIAID has a much larger placebo-controlled AZT trial underway in asymptomatic people who are HIV-infected. Results from the 3,210 patient trial, begun in 1987, may be available in the next few weeks, according to Fauci. Burroughs Wellcome has a smaller trial underway in HIV-infected asymptomatic people. In addition, NIAID is still recruiting for a placebo-controlled AZT trial in asymptomatic hemophiliacs. The trial was begun in April 1988 and has enrolled 187 people to date.
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