Abstract

AIDS: 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.