Protease inhibitors: major study stopped when 3-drug arm proves superior. Clearinghouse, AIDS Newsletter Database, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5714. A fee will apply.

Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.

Protease inhibitors: major study stopped when 3-drug arm proves superior. Clearinghouse, AIDS Newsletter Database, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5714. A fee will apply.

AIDS Treat News. 1997 Mar 7;(No 266):7-8. Unique Identifier : AIDSLINE AIDS/97702535

Abstract: ACTG 320, a clinical trial comparing indinavir/AZT/3TC to AZT/3TC was stopped early when it became clear that the 3-drug combination was superior to the 2-drug combination. Aside from the superiority of one combination over the other, the study was considered controversial by activists based on the following: the study was not long enough to determine long-term toxicity; the study did not determine when to start therapy since only patients with CD4 counts under 200 were selected and results were driven by those with CD4 counts under 50; the concerns about the opportunity cost of using government resources for product-oriented trials; and enrollment of persons in suboptimal trials because they had no other options. Disease progression, death, and other clinical endpoint issues are addressed. Therapies are changing so rapidly that studies lasting long enough to determine clinical endpoint benefits may no longer be the most effective.

Keywords: Anti-HIV Agents/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Drug Therapy, Combination HIV Infections/*DRUG THERAPY HIV Protease Inhibitors/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Human Indinavir/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Lamivudine/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Treatment Outcome Zidovudine/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE NEWSLETTER ARTICLE CLINICAL TRIAL
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M9781216

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