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Cellegy to stop phase 3 trial of Savvy gel in HIV infection
By Lisa Kerner
Charlotte, N.C., Aug. 28 - Cellegy Pharmaceuticals, Inc. said the Nigerian-based phase 3 safety trial of its Savvy (C31G vaginal gel) to reduce women's risk for HIV infection will be discontinued by the Family Health International after a lower-than-expected seroconversion rate was observed.
The decision to stop the trial was based on a recommendation from the study's independent Data Monitoring Committee.
Interim data did not support Savvy's effectiveness in reducing HIV infection and the committee determined that the study was unlikely to detect a reduction in HIV risk if continued.
The expected annual rate of new HIV infections was 3.7% at the start of the trial. Two years in to the study, the rate of new infection was less than 2%.
Cellegy said the low seroconversion rate could be due to counseling on HIV prevention and distribution of condoms.
The Nigerian trial, funded by United States Agency for International Development and begun in September 2004, was part of an international effort to evaluate microbicides in reducing the risk of HIV infection, according to a company news release.
Half of the 2,152 women enrolled in the study were given Savvy gel, and half were given a placebo gel to be inserted vaginally using pre-filled applicators prior to intercourse. The women were also counseled and provided with condoms.
Each month for one year, study participants were tested for HIV and reported on their use of the gel and condoms, as well as any side effects.
The U.S. phase 3 trial of Savvy for contraception is proceeding as planned, officials said.
Cellegy is a specialty biopharmaceutical company located in Huntingdon Valley, Pa.
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