CELLEGY TO END USAID-FUNDED MICROBICIDE STUDY

Cellegy Pharmaceuticals has announced it plans to discontinue the Phase III trial of Savvy (C31G vaginal gel) being conducted in Nigeria to determine whether it is safe and effective for reducing women's risk of acquiring HIV. Funded by United States Agency for International Development (USAID), the trial was part of an international effort to evaluate microbicides as a tool to reduce the risk of HIV infection.

The decision followed a recommendation during a meeting of the study's external, independent data monitoring committee. After reviewing the study data to date, committee members concluded that the trial was unlikely to provide convincing evidence that Savvy protects against HIV.

The trial in Nigeria began screening volunteers in September 2004 and enrolled a total of 2,152 women. Half of the women were given and half were given a placebo gel. At monthly visits during a yearlong follow-up, each participant was tested for HIV and reported on use of the gel and condoms, and any side effects or medical problems.

Each participant also received counseling on reducing the risk of HIV infection and condoms. These measures may have contributed to the lower than expected rate of new HIV infections in the study population.