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SAVVYH (C31G) Gel for Prevention of HIV infection in Women: A Phase 3, Double-Blind, Randomized, Placebo- Controlled Trial in Ghana 1 1 2 3 3 2 Leigh Peterson , Kavita Nanda *, Baafuor Kofi Opoku , William Kwabena Ampofo , Margaret Owusu-Amoako , Andrew Yiadom Boakye , Wes 1 1 1 4 1 Rountree , Amanda Troxler , Rosalie Dominik , Ronald Roddy , Laneta Dorflinger 1 Family Health International, Durham, North Carolina, United States, 2 Komfo Anokye Teaching Hospital, Kwame Nkrumah University of Science Technology, Kumasi, Ghana, 3 Noguchi Memorial Institute for Medical Research, University of Ghana, Accra, Ghana, 4 Duke Clinical Research Institute, Durham, North Carolina, United States Objective. The objective of this trial was to determine the effectiveness of 1.0% C31G (SAVVY) in preventing male-to-female vaginal transmission of HIV infection among women at high risk. Methodology/Principal Findings. This was a Phase 3, double-blind, randomized, placebo-controlled trial. Participants made up to 12 monthly visits for HIV testing, adverse event reporting, and study product supply. The study was conducted between March 2004 and February 2006 in Accra and Kumasi, Ghana. We enrolled 2142 HIV-negative women at high risk of HIV infection, and randomized them to SAVVY or placebo gel. Main outcome measures were the incidence of HIV-1 and HIV-2 infection as determined by detection of HIV antibodies from oral mucosal transudate specimens and adverse events. We accrued 790 person-years of follow-up in the SAVVY group and 772 person-years in the placebo group. No clinically significant differences in the overall frequency of adverse events, abnormal pelvic examination findings, or abnormal laboratory results were seen