Rationale: Pre-exposure prophylaxis is a strategy that aims to use antiretrovirals to reduce the risk of HIV infection. Studies in non-human primates have shown that both oral and topical applications of ARVs before exposure reduce risk or completely prevent infection with challenge by an HIV-like virus that causes disease in monkeys.
TDF (marketed under the name Viread) is an antiretroviral used by HIV-positive people as part of highly active antiretroviral therapy.
Study questions: This trial is designed to examine the safety of a PrEP strategy (once-daily tenofovir) in HIV-negative men who have sex with men.
Participants: 400 HIV-negative gay men and other men who have sex with men
Country: US (San Francisco, Atlanta, and Boston)
Trial sponsors and collaborators: US Centers for Disease Control and Prevention (CDC)
When were results released? Primarily findings were announced July 2010. Preliminary data show no significant differences of HIV risk behavior among men who were taking the pill at the beginning of the study, compared to those who started at month nine after enrollment. The trial reported no serious adverse events on the basis of its preliminary analysis. Additional data analyses are still underway. This trial was not designed to evaluate the effectiveness of PrEP.
To learn more visit:
http://www.cdc.gov/hiv/resources/factsheets/prep.htm
http://clinicaltrials.gov/ct2/show/NCT00131677?term=CDC+4323&rank=1