Phase II/IIb Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and 0.5% PRO2000/5 Gel (P) for the Prevention of HIV Infection in Women
Sponsors: Division of AIDS, US National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Protocol Summary: HPTN/MTN 035 was a four-arm, multi-center Phase II/IIb randomized controlled trial that aimed to determine the safety and effectiveness of two different candidate microbicides, BufferGel® and PRO 2000 (0.5% PRO 2000/5 Gel (P)) for the prevention of HIV in women. Participants were randomly assigned to one of four study groups: BufferGel, PRO 2000 gel, placebo gel, and no gel. The study enrolled its first participant in February 2005. Accrual was completed in July 2007 at which time a total of 3,100 sexually active HIV-negative women had been enrolled at seven sites in Malawi, South Africa, Zambia, Zimbabwe, and the United States.
Years: 2005 – 2008
Investigator: Z.M. Chirenje, MD, FRCOG
Locations: Spilhaus and Seke South CRSs