Study Suggests Microbicide Gel Does Not Protect Against HIV Infection in Women
“An investigational vaginal gel that had demonstrated in earlier testing some potential for inhibiting male-to-female sexual transmission of HIV was ineffective when tested in a larger clinical trial, according to findings announced today by the Microbicides Development Programme (MDP), a not-for-profit partnership of 16 African and European research institutions.
“In the earlier NIAID-funded HPTN 035 study, a Phase II/IIb clinical trial involving more than 3,000 women in Africa and the U.S., the microbicide gel PRO 2000 (Endo Pharmaceuticals, Chadds Ford, Pa.) proved to be safe and 30 percent effective at preventing HIV infection…. The finding, which was announced in February 2009 at the Conference on Retroviruses and Opportunistic Infection, was not statistically significant, meaning that the gel’s effect may have been the result of chance rather than a true protective effect.
“In the recently concluded Phase III MDP 301 study, which enrolled 9,385 women in four African countries, PRO 2000 once again proved safe but demonstrated no evidence of reducing the risk of HIV infection compared to placebo gel....
“Based on the combined results of both the HPTN 035 and MDP 301 studies, it can be concluded that PRO 2000 is safe but does not protect against HIV infection.”
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