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Indevus Pharmaceuticals Announces PRO 2000 Found to Show Promise in Large HIV Prevention Study
Date:2/9/2009

ed by the NIH-funded Microbicide Trials Network (MTN) at seven clinical centers in Malawi, Zimbabwe, South Africa, Zambia, and the United States.

The trial was initiated in February 2005 and enrolled approximately 3,100 eligible, HIV-uninfected women, all of whom provided written informed consent. Enrolled participants were randomly assigned to one of four arms: PRO 2000 gel (0.5% strength), BufferGel, a placebo gel, or no gel. Women enrolled in the three gel arms were asked to apply the assigned study product vaginally up to one hour before each act of sexual intercourse. The gel arms were double-blinded so that neither the participant nor the study staff knew the identity of the assigned study product. Women in all four arms received a standard-of-care HIV prevention package, which included free male condoms, risk-reduction counseling, and treatment of sexually transmitted infections. Participants were followed for 12-30 months (20 months on average), depending on when they entered the study.

A total of 194 new HIV infections occurred among study participants over the course of the trial. Of these, 36 occurred in the PRO 2000 arm, 54 in the BufferGel arm, 51 in the placebo arm, and 53 in the no-gel arm. Based on these data, PRO 2000 was 30 percent effective (approximately 33 percent effectiveness would have been considered statistically significant). The adverse event profile was similar in all four arms, indicating that 0.5% PRO 2000 is safe for vaginal use. A full analysis of the trial data is underway.

The study was conducted in communities where the background rate of HIV infection is high. Participants who became infected with HIV during the trial were referred to local HIV care and support services. Where possible, infected participants were invited to participate in Microbicide Trials Network (MTN) 015, a clinical study examining the nature of HIV progression and treatment response in HIV-positive
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SOURCE Indevus Pharmaceuticals, Inc.
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