title: SAVVY vaginal gel (C31G) for prevention of HIV infection: a randomized controlled trial in Nigeria.
abstract: 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.
  
  
  RESULTS
  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 ratio 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 incidence, we did not observe the required number of HIV infections (66) for adequate power to detect an effect of SAVVY. Follow-up frequencies of adverse events, reproductive tract adverse events, abnormal pelvic examination findings, chlamydial infections and vaginal infections were similar in the study arms. No serious adverse event was attributable to SAVVY use.
  
  
  CONCLUSIONS
  SAVVY did not reduce the incidence of HIV infection. Although the hazard ratio was higher in the SAVVY than the placebo group, we cannot conclude that there was a harmful treatment effect of SAVVY.
authors.affiliation: Family Health International, Research Triangle Park, North Carolina, USA. pfeldblum@fhi.org
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Feldblum
authors.forename: Adesina
authors.initials: A
authors.lastname: Adeiga
authors.forename: Rashidi
authors.initials: R
authors.lastname: Bakare
authors.forename: Silver
authors.initials: S
authors.lastname: Wevill
authors.forename: Anja
authors.initials: A
authors.lastname: Lendvay
authors.forename: Fatimah
authors.initials: F
authors.lastname: Obadaki
authors.forename: M Onikepe
authors.initials: MO
authors.lastname: Olayemi
authors.forename: Lily
authors.initials: L
authors.lastname: Wang
authors.forename: Kavita
authors.initials: K
authors.lastname: Nanda
authors.forename: Wes
authors.initials: W
authors.lastname: Rountree
mesh_terms: D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D015658:HIV Infections / Q000517:prevention & control* / Q000635:transmission; D006801:Humans; D008297:Male; D009549:Nigeria; D010349:Patient Compliance; D010919:Placebos; D012725:Sexual Behavior; D014621:Vagina
chemical_list: D019380:Anti-HIV Agents; D005782:Gels; D010919:Placebos