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Preliminary analyses from the first study to examine the clinical and behavioral safety of tenofovir taken daily for HIV prevention among gay and bisexual men suggest no significant safety concerns. A prior study in Ghana, Nigeria and Cameroon found that the drug was safe among heterosexual women at high risk. The MSM study findings were presented today by CDC’s Dr. Lisa Grohskopf at the XVIII International AIDS Conference in Vienna, Austria.
The approach of taking a daily antiretroviral drug to try to prevent HIV infection is known as pre-exposure prophylaxis, or PrEP, and studies around the world are currently underway to determine if it is effective at reducing HIV infection among individuals at high risk, including MSM. While the results of those studies will be needed to determine if PrEP can prevent HIV, this safety study lends additional assurance that the strategy may be well-tolerated among MSM, should it prove effective.
The Phase II safety study was conducted by the U.S. Centers for Disease Control and Prevention in collaboration with the San Francisco Department of Public Health, the AIDS Research Consortium of Atlanta, and Fenway Community Health in Boston. The trial examined whether a 300 mg tablet of tenofovir disoproxil fumarate taken daily was safe among 400 HIV-negative men who have sex with men (MSM) in San Francisco, Atlanta, and Boston. The study would not have been possible without the commitment and dedication of the trial participants.
Participants were randomly assigned to one of four study arms, and neither researchers nor participants knew an individual’s group assignment. Participants in two arms of the study received either tenofovir or placebo (a tablet without active medication) immediately upon enrollment, while participants in the remaining two arms received either tenofovir or placebo after nine months of enrollment. This design allowed researchers to compare risk behaviors among those taking a daily pill and those not taking pills.
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