February 25, 2008
Phase III Microbicide Clinical Trial Shows Carraguard is Safe But Not Effective against HIV Transmission in Women
A Phase III clinical trial of the microbicide Carraguard has found that although the vaginal gel, designed to be applied before intercourse, proved safe it did not prevent male-to-female transmission of HIV during vaginal intercourse. Carraguard, which was developed by the Population Council, is the first anti-HIV microbicide candidate to complete Phase III testing.
Results from the Carraguard trial, conducted at three sites in South Africa and funded by the U.S. Agency for International Development and the Bill and Melinda Gates Foundation, showed no significant difference in the incidence of safety-related side effects between the volunteers in the Carraguard group and the placebo group. The results also showed similar rates of HIV infection in both groups—134 new infections in the experimental arm compared to 151 new infections in the placebo arm.
This news is disappointing for the HIV prevention field. The International AIDS Vaccine Initiative (IAVI) strongly believes in the development of a range of prevention tools to combat HIV/AIDS. IAVI believes that preventive AIDS vaccines and female microbicides have the potential to drastically improve the lives of women, who comprise 48 percent of people living with HIV globally. Health advocates must continue to promote existing female-initiated methods, such as the female condom, and, whatever the scientific challenges, develop new tools that women can use to prevent HIV transmission with or without their partner’s cooperation. A preventive vaccine would be the ultimate prevention tool. Even a partially-effective, first-generation vaccine given to only a fraction of the population would save millions of lives.
The Feb. 18 Population Council press release on the Carraguard trial is available by clicking here.