PRO 2000 misses HIV endpoint

The Microbicides Development Programme (MDP) said the 0.5% dose of PRO 2000 vaginal microbicide gel missed the primary endpoint of significantly reducing the rate of HIV infection at 12 months vs. placebo in a Phase III trial to prevent sexually acquired HIV (130 vs. 123 new infections, p=0.712). The double-blind, African trial, which was conducted by MDP and sponsored by the U.K.'s Medicinal Research Council (MRC), enrolled 9,385 sexually active, HIV-negative women. MDP said it will no longer perform research on the gel. Last year, the high-dose 2% PRO 2000 gel arm was discontinued based on preliminary data suggesting the dose was unlikely to show a benefit vs. placebo (See BioCentury Extra, Friday, Feb. 15, 2008). ...