Statement of Anthony S. Fauci, M.D., Director, NIAID, NIH, on Results From the CAPRISA 004 Microbicide Study

Today we congratulate the Centre for the AIDS Programme of Research in South Africa (CAPRISA) and the people of South Africa on the positive findings from the CAPRISA 004 microbicide study, which marks a significant milestone both for the microbicide research field and HIV prevention as a whole.

For years, antiretroviral medicines have been effectively used to treat HIV infection. Through the successful conduct of the CAPRISA 004 study, we now have proof that an antiretroviral drug, in this case tenofovir, can be formulated into a vaginal gel that can protect women against HIV infection. Given that women make up the majority of new HIV infections throughout the world this finding is an important step toward empowering an at-risk population with a safe and effective HIV prevention tool.

The CAPRISA 004 study is an exciting scientific achievement that moves us one step forward to gaining another effective tool to prevent HIV infection. However, because no one approach will be appropriate or acceptable to all, we must continue to pursue a range of HIV prevention modalities, including microbicides, PrEP, and vaccines, as we simultaneously pursue scientific strategies designed to bring us closer to finding a cure for HIV/AIDS.

The daunting nature of the HIV/AIDS pandemic makes it clear that no single organization can tackle the problem alone. The CAPRISA 004 study is an excellent example of what researchers, governments, countries, industry, communities and individual study volunteers can accomplish when working together to find public health solutions. NIAID is proud to be among the many partner organizations that provided significant support and resources to establish the infrastructure and training necessary to conduct this landmark clinical trial.

Now we must build upon the CAPRISA research and identify a highly effective and acceptable microbicide for women and other groups at high-risk for HIV infection. The NIAID-sponsored VOICE study, which launched last fall and is expected to enroll 5,000 women in four south African countries, will provide additional safety and effectiveness data for a tenofovir-based vaginal gel as an HIV prevention method. The study also will offer some insight as to the gel's acceptability as a product used once a day rather than one that is used before and after sexual intercourse. Additionally, the VOICE study is examining oral antiretroviral tablets (tenofovir alone or tenofovir plus emtricitabine) as an HIV prevention method. This approach is known as pre-exposure prophylaxis, or PrEP. NIAID and other research organizations are exploring PrEP strategies in studies involving a number of at-risk populations with the first results expected early next year.

Dr. Fauci is director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health in Bethesda, Maryland.