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Ushercell HIV prevention study starts

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Polydex/Conrad's Ushercell (cellulose sulfate) Phase III studies will test the microbicidal gel's efficacy in prevention of HIV and other sexually transmitted infections. The first HIV prevention study, cleared by FDA in summer 2004, is underway in Nigeria. "A second study's protocol has just been approved by the FDA and will be conducted by Conrad in several countries with a high incidence of HIV infection," Polydex says. Both placebo-controlled studies are enrolling HIV negative women who are at high-risk of contracting HIV through vaginal intercourse. Contraceptive studies of cellulose sulfate are ongoing...

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