CDC Trials: Pre-Exposure Prophylaxis for HIV Prevention:Clinical Trials in Botswana, Thailand, and the United States

This information sheet discusses the clinical trials of the antiretroviral drug tenofovir disoproxil fumarate used alone or in combination with emtricitabine in Botswana, Thailand, and the United States. The trials in Botswana and Thailand are safety and efficacy trials, while the US trial is an extended safety trial. The trials are investigating the safety and efficacy of tenofovir as a daily oral prevention of HIV infection among three high risk populations: heterosexuals in Botswana, intravenous drug users in Thailand, and men who have sex with men in the US. The report discusses the rationale for these trials, the known characteristics of the drug, the trial designs and objectives, education and enrollment of participants, risk reduction counseling and other prevention and treatment services being offered, monitoring for side effects, and community involvement.