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Program History Population Council researchers have been working for nearly two decades to develop safe and effective microbicides. Microbicides are being developed as a female-initiated method for reducing male-to-female transmission of HIV, and possibly other sexually transmitted infections (STIs), when used during sex. A microbicide would mostly likely be formulated as a vaginal gel, cream, foam, or ring. If proven viable, microbicides will offer a powerful new prevention tool in the fight against AIDS. The majority of new HIV infections occur through heterosexual intercourse, and an estimated 19.2 million women worldwide are now HIV-positive. Infection in women is driven by social, cultural, and economic gender inequalities that limit women's ability to protect themselves from infection. The existing strategies for prevention—abstinence, mutual monogamy among HIV-negative partners, condom use, and treatment of STIs (because the presence of STIs can facilitate HIV transmission)—are not feasible for many women. Motivated by this urgent situation, the Population Council started studying HIV transmission in the late 1980s, a commitment that resulted in a major microbicide product-development effort in the early 1990s. Council researchers aim to develop a microbicide that will be widely available, stable in tropical climates, and affordable even to the world's poorest women. The Council's microbicides program draws on the wide range of expertise among its biomedical, public health, and social science researchers at its New York headquarters and its offices around the world. Council laboratory scientists conduct basic research to understand the sexual transmission of HIV—using both in vitro and in vivo models—and to test a variety of potential compounds for activity against HIV and other sexually transmitted pathogens. This work resulted in the development of the Council's candidate microbicide, Carraguard®, a gel whose main ingredient is carrageenan, which is derived from seaweed. Beginning in 1996, the Population Council conducted several Phase 1 safety and acceptability trials of carrageenan-based candidate microbicide gels for vaginal use in healthy, HIV-negative women in six countries, including the United States. Following these early trials, the Council completed two Phase 2 expanded safety and acceptability trials of Carraguard in collaboration with colleagues in South Africa and Thailand. The Phase 3 clinical trial of Carraguard did not demonstrate that Carraguard is effective in preventing male-to-female HIV transmission during vaginal intercourse. Carraguard was shown to be safe for use during vaginal sex over a two-year period. This finding is important because Carraguard is an ingredient of next-generation microbicide candidates being developed at the Council. Several of these candidates combine Carraguard with one or more ingredients that have been shown to be effective in preventing virus transmission in laboratory settings. Carraguard is the first candidate microbicide to have completed a Phase 3 trial without any safety concerns. (news release) In addition to conducting clinical trials, Council staff members have addressed important questions of ethical trial design and informed consent and have raised awareness about the need for microbicides. The Council's comprehensive microbicides program—managing all aspects of research from the laboratory to the field to product introduction to public education—has been instrumental in securing support from a wide range of donors: the US Centers for Disease Control and Prevention (CDC); the National Institutes of Health; the US Agency for International Development; the Bill & Melinda Gates, The William and Flora Hewlett, The Andrew W. Mellon, and The Rockefeller foundations; the Parthenon Trust; the Swedish International Development Cooperation Agency; and the UK Department for International Development. Council researchers also are working on basic research on HIV transmission, social science research, and public education opportunities to advance AIDS prevention. Carraguard® is the Population Council's US trademark for pharmaceutical preparations, namely microbicides, for use in preventing infection. See Also
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