The HPTN 052 Study is a Phase III, controlled, randomized clinical trial to assess the effectiveness of immediate versus delayed antiretroviral therapy strategies on sexual transmission of HIV-1. It was selected by the Science Magazine as the Breakthrough of the Year for 2011 (Alberts, 2011; Cohen, 2011), based on the paper “Prevention of HIV-1 Infection with Early Antiretroviral Therapy” (Cohen, et al., 2011). In this talk, we will focus on the involved statistical issues and methods, and discuss the challenges that lie ahead to extend the HPTN 052 study.
Alberts, B (2011) Science breakthroughs, Science, 334: 1604
Cohen, J. (2011) HIV treatment as prevention, Science, 334: 1628
Cohen, MS, Chen, YQ, McCauley, M, et al. (2011) Prevention of HIV-1 infection with early antiretroviral therapy, New England Journal of Medicine, 365: 493-505