|
| ||||||
MEDIA CENTER Bill & Melinda Gates Foundation Supports Clinical Trials of Population Council's Lead Candidate AIDS-fighting Microbicide
NEW YORK (2 February 2002) — The Population Council announced today that it plans to begin the clinical trials of its lead candidate microbicide, Carraguard™, by the end of 2002. A $20 million grant from the Bill & Melinda Gates Foundation, announced today, 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, 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. A pioneer in this effort, the Population Council in 1986 began the study of HIV transmission, which resulted in a major microbicide product-development effort in the early 1990s. It is now one of the first organizations to launch a full-scale, Phase III trial to test the effectiveness of a 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. Many women cannot ensure the monogamy of their sexual partners, nor can they always negotiate condom use," said Linda Martin, president of the Population Council. "And the development of a vaccine has not gone as quickly as we all had hoped." Population Council researchers aim to develop a microbicide that will be widely available, stable across temperature ranges, and affordable even to the world's poorest women. A comprehensive, cross-functional effort, this research began in the Council's laboratories as an investigation of the sexual transmission of HIV. The next step was to translate this basic science into a viable product—a process in which the Council has a strong track record. Tests of preliminary formulations in the laboratory indicated potential effectiveness. As lab work was progressing, a group of the Council's clinical and social scientists worked to raise awareness among public and private sector leaders about the need for microbicides. They collaborated with other experts to examine women's and men'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 teams, resulting in this promising formulation. Council researchers and collaborators have conducted safety trials on Carraguard in South Africa, Thailand, the United States, 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, 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 (CDC), the University of Cape Town, and the Medical University of Southern Africa. Researchers anticipate that the Phase III trial will last approximately four years, and that results will be available in 2006. Other funding for the Council's microbicide work has come from the National Institutes of Health; the U.S. Agency for International Development; the Rockefeller, Mellon, and Hewlett Foundations; the Parthenon Trust; the Swedish International Development Cooperative Agency; and the U.K. Department for International Development. This is the third grant supporting microbicides research to the Population Council from the Gates Foundation.
|
