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Leading advocates express support for microbicide research, despite disappointing trial results

HIV prevention advocates from three major civil society organizations today emphasized the importance of continued research into new HIV prevention options, despite the recent discontinuation of the Phase III effectiveness trials of the microbicide candidate, cellulose sulfate (CS).

CS was one of the four microbicide candidates in Phase III effectiveness trials for prevention of HIV and other sexually transmitted infections. CONRAD, a reproductive health research organization, was conducting Phase III trials to assess its effectiveness in Benin, India, South Africa, and Uganda. Another Phase III trial of CS sponsored by Family Health International was underway in Nigeria. Both sponsors are not-for profit research groups dedicated to advancing health in developing countries.

At the recommendation of their respective Data Safety Monitoring Boards both sponsors chose to discontinue their CS trials after findings from the CONRAD trial suggested that CS might be contributing to an increased risk of HIV infection. Although review of the data from the Nigerian trial found no evidence of increased risk, FHI felt that the only responsible course of action was to halt its study also.

"Of course we wish the results had been different, but learning what doesn't work can be just as important to progress as learning what does work," observed Lori Heise, Director of the Global Campaign for Microbicides (GCM). "It's also reassuring that the independent Data Safety and Monitoring Committees, put in place to identify problems early on in a trial, appear to have worked well. Advocates have been instrumental in pushing for extra mechanisms to help protect participant safety."

African advocates are following the trials conducted in their countries particularly closely, reported Manju Chatani, Coordinator of the African Microbicide Advocacy Group (AMAG). "Scientists scrutinized the data available on cellulose sulfate before the Phase III trials s
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Contact: Lori Heise
lheise@path.org
202-454-5028
AIDS Vaccine Advocacy Coalition (AVAC)
31-Jan-2007


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