PEPFAR Statement on CAPRISA 004 Trial Results

July 19, 2010

Media Contact:
Jennifer Peterson +1 202 255 9545,

Vienna, Austria – Ambassador Eric Goosby, U.S. Global AIDS Coordinator, released the following statement on the CAPRISA 004 trial results:


“The results of the CAPRISA 004 trial provide new hope and direction for not only HIV prevention, but also broader efforts under the U.S. Global Health Initiative. We recognize that microbicides will be a great asset to HIV prevention efforts, and the U.S. Government is pleased to support this important research through USAID as part of the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR).


“All welcome the potential addition of a new tool to our HIV prevention approaches. As highlighted this week at the International AIDS Conference in Vienna, there is a great need for innovation in HIV prevention – particularly one that gives a woman more ways to protect herself from HIV. By helping people remain free of infection, we prevent HIV-related morbidity and mortality – and help countries avoid the costs of antiretroviral treatment. As we move forward with our work around microbicides, it will be important to know about impact in particular populations; ultimately, a microbicide may be particularly helpful if targeted to groups at increased risk.


“This proof-of-concept trial is a key step, but there are additional steps that need to take place before the world can begin using this antiretroviral drug-based microbicide. Several ongoing trials will provide us with more information, and additional trials will likely be pursued to validate this data. Careful monitoring of resistance and side effects will be part of the research, and safety with long-term use will be another key question. If ARVs are used in prevention, there will be a need to determine optimal strategies for making the microbicide available, including comprehensive counseling on adherence, incorporation of HIV counseling and testing, resistance monitoring, and the potential impact of pre-exposure prophylaxis on future treatment options among users who acquire HIV.


“Among many potential benefits, this may be a needed stimulus to encourage people to get tested for HIV, and PEPFAR will continue to support countries in expanding HIV counseling and testing programs. PEPFAR will be able to integrate these products into programs when normative guidance is issued. Complex operational, implementation and marketing questions relevant to real-world effectiveness will require answers. We hope there will be continued good news on the research front and look forward to engaging with these issues.”




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