FHI partnered with the Centre for the AIDS Programme of Research in South Africa (CAPRISA) at the University of KwaZulu-Natal and with U.S.-based CONRAD to conduct the first study of a microbicidal product containing an antiretroviral drug. The CAPRISA 004 trial assessed the effectiveness and the safety of a vaginal gel containing 1% tenofovir for the prevention of HIV infection in South African women. Tenofovir is an antiretroviral drug that is widely used in the treatment of HIV. Results were announced at the XVIII International AIDS Conference in Vienna, Austria, on Tuesday, July 20, 2010.
Key results of CAPRISA 004
Tenofovir gel--used before and after sex--reduces HIV infections by 39 percent. Women who used the gel more often were up to 54 percent less likely to contract HIV.
Tenofovir gel--used before and after sex--reduces genital herpes infections by 51 percent.
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Implications of CAPRISA 004
Tenofovir gel is an important new HIV prevention technology because, unlike other HIV prevention tools, it is controlled by the woman. That is significant because more than half of all new HIV infections worldwide occur in women and girls.
Tenofovir gel has the potential to have a huge impact on HIV prevention and to save millions of lives in the next two decades.
Next step
Results of CAPRISA 004 need independent scientific confirmation before tenofovir gel can achieve regulatory approval for public use.
Partners
The study was funded by the United States Agency for International Development (USAID) and the Technology Innovation Agency (TIA), a biotechnology agency of the South African government's Department of Science and Technology. In addition, Gilead Sciences provided tenofovir for the manufacture of the gel used in the study.
FHI provided the following technical assistance to the CAPRISA 004 trial:
- Protocol development
- Statistical design and analysis
- Behavioral research and design
- Evaluation of safety reports for trial participants
- Clinical monitoring
- Ethical oversight and study safety oversight
- Communications
More information
Press release
Study backgrounder (PDF, 83 KB)
Questions and Answers (PDF, 109 KB)
Collection of factsheet summaries (PDF, 117 KB)
Factsheet on effectiveness (PDF, 105 KB)
Factsheet on safety (PDF, 133 KB)
Factsheet on adherence (PDF, 107 KB)
Factsheet on HSV-2 (PDF, 104 KB)
Factsheet on drug resistance (PDF, 100 KB)
Factsheet on pregnancy (PDF, 105 KB)
International AIDS Conference presentation (PDF, 1.1 MB)
FHI video on YouTube
CAPRISA video on YouTube
FHI's Insight Live
"Gel Cuts AIDS, Herpes Risk for Women" -- The Wall Street Journal
"Studies Offer 2 Paths to Cut H.I.V. Rate for African Women" -- The New York Times
"Hot Topic: Prevention of HIV Infection in Women" -- Science Magazine
USAID press release
CAPRISA Web site
CONRAD Web site
