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Joint statement on Savvy Phase 3 trial in Ghana to test the effectiveness of Savvy Gel in preventing HIV

Research Triangle Park, NC and Huntingdon Valley, PA -- International efforts are underway to evaluate microbicides as a tool to prevent HIV infection in people at high risk. As part of this initiative, with funding from the U.S. Agency for International Development (USAID), Family Health International (FHI) and Cellegy Pharmaceuticals, Inc. have been working to see if a vaginal gel called Savvy is effective in preventing male-to-female transmission of HIV among women at high risk of infection in West Africa. Other organizations are conducting trials in the United States to determine if Savvy is effective as a contraceptive.

Family Health International and Cellegy Pharmaceuticals announced today that they plan to stop the HIV prevention trial of Savvy being conducted by FHI in Ghana. This decision followed a recommendation of the study's external, independent Data Monitoring Committee (DMC). The DMC reviewed the study data to date and concluded that, while there is no evidence of safety concerns based on the comparative HIV infection rates in the Savvy and placebo groups, the Ghana study would be unable to evaluate the effectiveness of the product.

The Savvy Phase 3 clinical trial in Ghana began recruitment in March 2004 and completed planned enrollment with 2,142 women in June 2005. Half of the women were given Savvy gel, and half were given a placebo gel to be inserted vaginally with pre-filled applicators. At monthly visits during each woman's year-long follow-up, each participant was tested for HIV and reported on use of the gel and any side effects or medical problems. Each participant received counseling for reducing her risk of HIV and was given condoms for use during all sexual acts. Eighteen months into the study, the observed HIV incidence in the cohort was about one-third the rate expected prior to the study.

"The reason we decided to stop the trial was that the group of women who volunteered to participate had such a low inciden
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Contact: Beth Robinson
media@fhi.org
919-405-1461
Rational PR
9-Nov-2005


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