FDA explores new antiretroviral trial designs: interview with David Feigal, M.D. [interview by John S. James]

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

FDA explores new antiretroviral trial designs: interview with David Feigal, M.D. [interview by John S. James]

AIDS Treat News. 1997 Jun 20;(No 273):1-5. Unique Identifier : AIDSLINE MED/97702688
Feigal D; Clearinghouse, AIDS Newsletter Database, P.O. Box 6003, Rockville, MD; 20849-6003. 800-458-5231 ext. 5714. A fee will apply.

Abstract: At its public meeting, July 14 and 15, the Food and Drug Administration's (FDA) Antiviral Drugs Advisory Committee will explore ways to design clinical drug trials so that they are completed faster and more safely. The FDA is considering changing the clinical endpoints requirement for antiretroviral confirmatory trials. Rather than waiting for a major disease event to occur, the new kind of trial would record effective viral suppression over a period of time. Dr. David Feigal of the FDA's Division of Antiviral Drug Products discusses the problems that the proposed changes should solve, the protocol designs, and how interested people can contact the Committee.

Keywords: *Anti-HIV Agents/THERAPEUTIC USE *Clinical Trials/METHODS *HIV Infections/DRUG THERAPY *Research Design
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