Department of Biostatistics Seminar/Workshop Series

Statistical Methods for a Long-Term HIV/AIDS Prevention Trial on Anti-Retroviral Therapy Strategies

Ying Qing Chen, Ph.D., Associate Member of Biostatistics

Vaccine and Infectious Disease Institute, Fred Hutchinson Cancer Research Center, Seattle, Washington

Wednesday, October 13, 1:30-2:30pm, MRBIII Conference Room 1220

Intended Audience: Persons interested in applied statistics, statistical theory, epidemiology, health services research, clinical trials methodology, statistical computing, statistical graphics, R users or potential users

The HIV Prevention Trial Network (HPTN) 052 Study is an ongoing Phase III randomized trial to evaluate the effectiveness of two antiretroviral therapy (ART) strategies in the treatment and prevention of HIV-1 infection. In this trial, 1750 sero-discordant couples were randomized for the infected partners to receive either immediate ART upon enrollment or delayed ART till having two consecutive CD4+ cell counts measured within or below the range of 200-250 cells/mm3, or developing AIDS-defining illnesses. The trial participants would be followed up to 60 months. In this talk, we will discuss several challenging issues in trial design, sample size calculation and trial monitoring due to the complexity of this study. We will further present a general statistical framework, and discuss several relevant methods developments that have broad applications in medical research.