savvy vaginal gel (c31g) for prevention of hiv infection a randomized controlled trial in nigeria精明的阴道凝胶(c31g)预防艾滋病毒感染在尼日利亚一个随机对照试验.pdfVIP

SAVVY Vaginal Gel (C31G) for Prevention of HIV Infection: A Randomized Controlled Trial in Nigeria 1 2 3 1 1 2 3 1 Paul J. Feldblum *, Adesina Adeiga , Rashidi Bakare , Silver Wevill , Anja Lendvay , Fatimah Obadaki , M. Onikepe Olayemi , Lily Wang , Kavita Nanda1, Wes Rountree1 1 Family Health International, Research Triangle Park, North Carolina, United States, 2 Nigerian Institute of Medical Research, Lagos, Nigeria, 3 College of Medicine, University of Ibadan, Ibadan, Nigeria Background. 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 follow-up visits for HIV testing, adverse event reporting, and study product supply. The study was conducted between September 2004 and December 2006 in Lagos and Ibadan, Nigeria, where we enrolled 2153 HIV-negative women at high risk of HIV infection. Participants were randomized 1:1 to SAVVY or placebo. The effectiveness endpoint was incidence of HIV infection as indicated by detection of HIV antibodies in oral mucosal transudate (rapid test) or blood (ELISA), and confirmed by Western blot or PCR testing. We observed 33 seroconversions (21 in the SAVVY group, 12 in the placebo group). The Kaplan-Meier estimates of the cumulative probability of HIV infection at 12 months were 0.028 in the SAVVY group and 0.015 in the placebo group (2-sided p-value for the log-rank test of treatment effect 0.121). The point estimate of the hazard ratio was 1.7 for SAVVY versus placebo (95% confidence interval 0.9, 3.5). Because of lower-than-expected HIV incidenc