HIV-Prevention Studies of SAVVY Vaginal Gel Stopped Because of Futility

Final results are now available for two USAID-supported clinical trials — one in Nigeria and one in Ghana — that were closed early because a low incidence of HIV among the participants prevented scientists from detecting an effect of the SAVVY candidate microbicide. For statistical reasons, a continuation of either study could not have established SAVVY's ability to prevent HIV infections.

Both studies began in 2004, when Family Health International (FHI) and its partners enrolled more than 4,000 HIV-negative women at high risk of HIV infection. Each participant in these Phase III trials was randomly assigned to receive either the SAVVY gel or a placebo gel.

The participants were instructed to use the assigned gel and a male condom at every act of sexual intercourse. Participants returned to the clinic on a monthly basis for 12 months to be tested for HIV and pregnancy. The participants reported their use of the gel and condoms, as well as the occurrence of any side effects or medical problems.

The new data show that no serious side effects were attributed to SAVVY use in the Nigerian study. Participants who used SAVVY in the Ghanaian study were slightly more likely to experience side effects in the reproductive tract than were users of the placebo. The Ghanaian study was closed in 2005, whereas the Nigerian study was closed in 2006.

To read more about these studies, click here (Nigeria) or here (Ghana).

Sources
Feldblum PJ, Adeiga A, Bakare R, Wevill S, et al. SAVVY vaginal gel (C31G) for prevention of HIV infection: A randomized controlled trial in Nigeria. PLoS ONE 2008;3(1):e1474.

Peterson L, Nanda K, Opoku BK, Ampofo WK, et al. SAVVY® (C31G) gel for prevention of HIV infection in women: A phase 3, double-blind, randomized, placebo-controlled trial in Ghana. PLoS ONE 2007;2(12):e1312.