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Phase III effectiveness clinical trials have begun for the potential anti-HIV microbicide cellulose sulfate (Ushercell), formerly called C31G, which already has demonstrated safety when used by women. (1-4)
If the trials go well, the product could be ready for approval by the Food and Drug Administration (FDA) by 2010.
Cellulose sulfate is being evaluated in two studies, each enrolling 2,400 women considered at high-risk of HIV infection, explains Henry L. Gabelnick, PhD, director of the Contraceptive Research and Development Programme (CONRAD) in Arlington, VA.
"In our studies, we're looking at women who are at high risk from having multiple sex partners per week and multiple acts of intercourse," he says.
Preliminary data show the microbicide is as effective as a spermicide as anything else that's available, and it's worked quite well in vitro as an anti-HIV microbicide, Gabelnick…
Source: HighBeam Research, Africa, India test sites for anti-HIV microbicide: cellulose sulfate...