Update | According to the Alliance of Microbicides Development, as of December 2005 there were 29 microbicides in active development. |
In March 2004, the Population Council launched a large-scale, three-year clinical trial of its lead candidate microbicide, Carraguard®, to test its efficacy in blocking the HIV virus and determine its safety over an extended period. If proven effective, this colorless, odorless gel will offer a powerful new tool against AIDS. Globally, women’s rates of HIV infection outpace men’s, and the existing strategies for prevention—abstinence, condom use, and mutual monogamy between HIV-negative partners—are not practical for most women. A successful trial will also demonstrate “proof of concept”—that consistent use of microbicides is a feasible means of thwarting HIV infection. With 60 microbicide candidates under development worldwide, proof of concept would be a significant achievement. Because of the urgent need for a female-controlled product useful to all women, the Council has focused to date on a vaginal, noncontraceptive microbicide; among additional microbicide formulations the Council has under development is a contraceptive formulation. The feminization of the pandemic - In Africa today, young women aged 15–24 are two and a half times more likely than young men to be infected.
- In sub-Saharan Africa, nearly 60 percent of all adults living with HIV/AIDS are female.
- In South Africa, of the first 1,500 women screened for the Carraguard trial, more than 20 percent were ineligible because of their HIV-positive status.
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The Carraguard trial is being conducted at three sites in South Africa in collaboration with the Medical University of Southern Africa, the University of Cape Town, and the Medical Research Council. A massive recruitment effort is under way to identify more than 6,000 HIV-negative, nonpregnant volunteers who can commit two years to the study. By the end of October 1,500 women were enrolled and randomly and anonymously assigned to one of two study groups. Not even the researchers know which group, to ensure they do not inadvertently cue participants and affect their behavior. One group is using the Carraguard gel, the other a placebo. Each group is instructed to use both a condom—the safest known way to protect against HIV/AIDS—and a gel during intercourse. Measurable infection rates are anticipated in both groups due to noncompliance; both receive benefits including free pap smears, condoms, counseling, and testing for sexually transmitted infections (STIs) and HIV/AIDS. Participants with STIs are treated before beginning the trial, and HIV-positive women are referred to hospital programs. “When we analyze the final data three years from now,” says Pekka Lähteenmäki, director of the Population Council’s Carraguard trial, “we will learn to what extent Carraguard protects women from HIV/AIDS. No one expects 100 percent protection, but even 50 percent efficacy could translate into hundreds of thousands, perhaps millions, of people being spared this disease.” Funding from a dozen major grantmaking institutions—in particular USAID—is supporting the Population Council’s search for a viable microbicide. A $20-million donation from the Bill and Melinda Gates Foundation has contributed significantly to this Carraguard trial. For more information, please visit our Web site at www.popcouncil.org/microbicides. With funding from the United States Agency for International Development (USAID) and in partnership with the Carraguard study sites, Council researchers have tested and honed tools critical to the trial process, including an informed-consent form, a booklet, and a 25-minute recruitment video. These materials, available in four languages, help to ensure that potential study volunteers understand the trial; facilitate recruitment and retention; and make certain that participants at all three sites get the same information. The August 2004 issue of Sexually Transmitted Diseases published an article by Council scientists who developed an accurate, rapid, and inexpensive method for verifying use of the vaginal applicator, an important tool for assessing and improving compliance. |
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