A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Acyclovir for the Reduction of HIV Acquisition Among High Risk HSV-2 Seropositive, HIV Seronegative Individuals
Sponsors: Division of AIDS, US National Institute of Allergy and Infectious Diseases (NIAD)
US National Institutes of Health (NIH)
Protocol Summary: HPTN 039 was a phase III, randomized, double-blind, placebo-controlled trial that aims to determine the efficacy of twice daily acyclovir in prevention HIV infection among high-risk HIV-negative, HSV-2 serpositive women and men who have sex with men (WSM and MSM) . WSM were enrolled at study sites in Lusaka, Zambia, Johannesburg, South Africa, and Harare, Zimbabwe. MSM were enrolled at study sites in Lima, Iquitos, and Pucallpa, Peru; Seattle, WA, USA; New York City; NY, USA; and San Francisco, CA, USA. The study was the largest clinical trial to date to examine herpes suppression as a possible means of reducing the risk of HIV transmission.
Years: 2004 – 2008
Investigator: Tsungai Chipato, MBChB, FRCOG, MCE
Location: Zengeza CRS
Celum C, Wald A, Hughes J, Sanchez J, Reid S, et al. (2008) Effect of acyclovir on HIV-1 acquisition on herpes simplex virus 2 seropositive women and men who have sex with men: a randomized, double-blind, placebo-controlled trial. Lancet 371(9630): 2109-19.