Bill & Melinda Gates Foundation Supports Clinical Trials of Population Council's Lead Candidate AIDS-Fighting Microbicide.Business Editors & Health/Medical Writers NEW YORK--(BW HealthWire)--Feb. 2, 2002 Council Celebrates 50th Year With Announcement of Its Largest Clinical Trial to Date Testing the Effectiveness of a Powerful New HIV- Prevention Product The Population Council announced today that it plans to begin the clinical trials of its lead candidate microbicide, Carraguard(TM), by the end of 2002. A $20 million grant from the Bill & Melinda Gates Melinda French Gates (born Melinda Ann French on August 15, 1964) is a former unit manager for several Microsoft products: Publisher, Microsoft Bob, Encarta, and Expedia. In 1994, she married Bill Gates, founder, chairman, and former chief software architect of Microsoft. Foundation will provide a substantial part of the funding needed for this large-scale study of 6,000 women in southern Africa
Microbicides are products designed to substantially reduce transmission of HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. , and possibly other sexually transmitted infections (STIs), when used in the vagina or rectum. If proven effective, such products will offer a powerful new prevention tool in the fight against AIDS. The Population Council is one of the first organizations to launch a full-scale, Phase III trial to test the effectiveness of its candidate microbicide gel. AIDS experts are increasingly acknowledging microbicide development as a critical prevention approach. "We are thrilled that the Gates Foundation has recognized this potential," said Linda Martin, president of the Population Council. "Many women cannot ensure the monogamy monogamy: see marriage. of their sexual partners, nor can they always negotiate condom use." Population Council researchers aim to develop a microbicide that will be widely available, affordable, and stable across temperature ranges. This research began in the Council's laboratories as an investigation of the sexual transmission of HIV. Researchers then translated this basic science into a viable product. Tests of preliminary formulations in the laboratory indicated potential effectiveness. Council researchers worked to raise awareness among public and private sector leaders about the need for microbicides. They examined people's willingness to use such a product and their preferences for how it might be dispensed. The findings of this field research informed the work of the biomedical bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. teams, resulting in this promising formulation. Council researchers and collaborators have conducted safety trials on Carraguard in South Africa, Thailand, the U.S., and four other countries to ensure it is safe and acceptable for women. Council scientists are now actively preparing for a Phase III trial that will test Carraguard's effectiveness in preventing the transmission of HIV and other STIs. With this grant from the Bill & Melinda Gates Foundation and funds yet to be raised, recruitment for the trial will begin in the second half of 2002. It is slated to be a randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , controlled, double-blind trial among 6,000 women in southern Africa. The Council proposes to collaborate with the U.S. Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center. (CDC See Control Data, century date change and Back Orifice. CDC - Control Data Corporation ), the University of Cape Town “UCT” redirects here. For other uses, see UCT (disambiguation). , and the Medical University of Southern Africa. The Phase III trial is expected to last approximately four years. The Population Council is an international, nonprofit, nongovernmental organization that conducts biomedical, social science, and public health research. Full release is available at www.popcouncil.org |
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