Rationale: The overall rationale for all microbicide trials is to identify products that could be used vaginally or rectally to help reduce the user's risk of HIV infection. These candidates could be formulated in many ways including as gels, suppositories, creams, and vaginal rings.
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.
Tenofovir gel is a gel containing the antiretroviral drug tenofovir, an antiretroviral used in its oral form by HIV-positive people as part of combination treatment. This microbicide aims to work within cells to stop HIV from replicating.
Study Questions: The study is designed to examine the safety and effectiveness of 1% tenofovir gel compared to placebo in preventing vaginally acquired HIV infection in sexually active women at risk for HIV infection.
Participants: 889 HIV-negative women
Country: South Africa
Trial sponsors and collaborators: Centre for the AIDS Programme of Research in South Africa (CAPRISA), CONRAD, Family Health International (FHI), United States Agency for International Development (USAID)
When were results released? Results were announced July 2010. The microbicide containing 1% tenofovir was found to be 39% effective in reducing a woman’s risk of becoming infected with HIV during sex and 51% effective in preventing genital herpes infections in the women participating in the trial.
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