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PROGRAM Data Collection Complete for Carraguard® Phase 3 Trial The Population Council and South African collaborators have completed data collection for the Phase 3 clinical trial of Carraguard®, the nonprofit organization’s lead first-generation candidate microbicide. Microbicides are being developed as a female-initiated method for reducing male-to-female transmission of HIV, and possibly other sexually transmitted infections, when used during sex. A microbicide would mostly likely be formulated as a vaginal gel, cream, foam, or ring. The objectives of the study were to assess Carraguard’s efficacy and long-term safety in preventing HIV infection when used vaginally by women during sex. The Phase 3 study began in March 2004, and enrollment was completed in June 2006. Results are expected by early 2008.* More than 6,000 women were enrolled and randomly assigned to use Carraguard or a placebo gel an hour or less before each act of vaginal intercourse. All women received condoms and were counseled and instructed on how to use them. Participants attended quarterly clinic visits for up to two years, during which time they received safer sex counseling, pelvic exams, HIV tests, and testing and treatment for curable sexually transmitted infections. The trial was conducted at three sites in South Africa: the Setshaba Research Centre, through the University of Limpopo/Medunsa campus; the Empilisweni Centre for Wellness Studies, through the University of Cape Town; and the Isipingo Clinic, through the Medical Research Council of South Africa. The high rates of HIV infection in the study communities make it statistically possible to assess whether or not Carraguard prevents infection. An external, independent Data Safety Monitoring Board reviewed the Carraguard data at three points during the trial to ensure the safety of study participants. In earlier studies, Carraguard was found to be safe and acceptable to both HIV-negative and HIV-positive women and men. Those safety studies were conducted on six continents including in Australia, Chile, the Dominican Republic, Finland, South Africa, Thailand, and the United States. Carraguard is made of carrageenan, a sulfated polysaccharide that has been used for hundreds of years and is on the US Food and Drug Administration’s list of products “Generally Recognized As Safe” for consumption and topical application. Laboratory research has shown Carraguard to be effective in blocking cells from becoming infected by HIV and in protecting mice from infection by herpes simplex virus, Neisseria gonorrhoeae, and human papillomavirus. Women need more options to protect themselves from HIV—and other sexually transmitted infections—because current prevention strategies are not always feasible. Although abstinence and condoms will remain the best methods of prevention, even a partially effective microbicide could significantly reduce rates of HIV infection by giving women a female-initiated protection option. If the clinical trial shows that Carraguard is efficacious in preventing HIV, the Population Council will work closely with manufacturers and international development organizations to facilitate affordable access to Carraguard in the developing world. Meanwhile, the Population Council’s biomedical scientists continue product development on second-generation microbicide candidates. More information about the Population Council’s microbicides program is available at www.popcouncil.org/microbicides. * The results of the Phase 3 Carraguard trial
have been announced. (news
release) This page updated |
