Abstract #301931

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JSM 2002 Abstract #301931
Activity Number: 155
Type: Contributed
Date/Time: Monday, August 12, 2002 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section*
Abstract - #301931
Title: Power of Different Endpoints in HIV Trials
Author(s): Tom Hammerstrom*+ and Guoxing Soon
Affiliation(s): Food and Drug Administration and Food and Drug Administration
Address: 19229 Staley Bridge, Germantown, MD, 20876, USA
Keywords:
Abstract:

Viral suppression in HIV trials has traditionally been measured in two ways, either as change from baseline or as percent below assay limit. Missing data makes change from baseline hard to compute accurately while it is biologically plausible that subjects discontinuing treatment experience viral rebound to above assay limit. However, more experienced populations may have significant viral reductions from baseline without reaching assay limit. There is, thus, a potential conflict as to which endpoint may be more powerful under differing circumstances. We will explore the power of these endpoints under a variety of assumptions about missingness, baseline level, and magnitude of treatment effect.

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Revised March 2002