HPTN 035 was a Phase 2/2B, multi-center, controlled, four-arm, randomized trial designed to determine the safety and effectiveness of two candidate microbicides, BufferGel and PRO 2000 gel, for the prevention of HIV in women. Participants were randomly assigned to one of four study groups: BufferGel, PRO 2000 gel, placebo gel, or no gel. Women assigned to the three gel groups were to apply gel up to one hour before sexual intercourse using pre-filled applicators. Each study participant was followed for at least one year. Secondary objectives of this study were to estimate the effectiveness of BufferGel and 0.5% PRO 2000 gel (P) in preventing the following among women at risk for sexually-transmitted HIV infection: BV, chlamydia infection, genital ulcer disease, gonorrhea infection, HSV-2 infection, pregnancy, syphilis infection, and trichomoniasis, and to assess the acceptability of BufferGel and 0.5% PRO 2000 Gel for use as vaginal microbicides. Preliminary results were first presented at the 16th Conference on Retroviruses and Opportunistic Infections (CROI) in 2009. The primary manuscript was published in AIDS on April 24, 2011.
US National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institute on Drug Abuse
US National Institutes of Health
Indevus Pharmaceuticals, Inc.
The University of Pennsylvania located in Philadelphia, Pennsylvania was also a site when the HPTN 035 study was active.