Population Council Research that makes a difference

Truvada Trial Among Women Discontinued

The Population Council would like to recognize FHI and the FEM-PrEP team for their important research on expanding HIV prevention options for women. The FEM-PrEP clinical trial was designed to determine whether HIV-negative women who are at higher risk of being exposed to HIV can safely use a daily dose of Truvada®, a pill containing two antiretroviral drugs, to prevent infection.

This effort to develop a women's prevention option was stopped after a review of interim trial data suggested that it is highly unlikely that the study product will demonstrate effectiveness in preventing HIV infection in women. This recommendation came from the trial's Independent  Data Monitoring Commission (IDMC), an external review board that provides additional oversight and further ensures client safety. There were no serious safety concerns among the participants.

This was an unexpected finding because a 2010 study showed that oral administration of the Truvada pill can reduce the likelihood of infection in men who have sex with men who are at high risk of contracting the infection.

"Although unanticipated, the closure of this trial must be seen within the context of recent positive developments in the field," says HIV and AIDS program director Naomi Rutenberg. "The Truvada men's study, promising findings from our colleagues at CAPRISA, and the Council’s own advances toward vaginal and rectal microbicides offer hope that we will develop a safe, effective HIV prevention product for both women and men."

FEM-PrEP is implemented by FHI in partnership with research centers in Africa. An organized closure of this trial, which enrolled nearly 2,000 volunteers in three countries, will be completed over the next few months. The trial's IDMC also commended the FEM-PrEP team on the quality of the study's clinical and ethical standards.

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The Population Council confronts critical health and development issues—from stopping the spread of HIV to improving reproductive health and ensuring that young people lead full and productive lives. Through biomedical, social science, and public health research in 50 countries, we work with our partners to deliver solutions that lead to more effective policies, programs, and technologies that improve lives around the world. Established in 1952 and headquartered in New York, the Council is a nongovernmental, nonprofit organization governed by an international board of trustees.

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Media contact

Diane Rubino: drubino@popcouncil.org; +1 212 339 0617