title: SAVVY (C31G) gel for prevention of HIV infection in women: a Phase 3, double-blind, randomized, placebo-controlled trial in Ghana.
abstract: 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.
  
  
  RESULTS
  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 between treatment groups. However, more participants in the SAVVY group reported reproductive tract adverse events than in the placebo group (13.0% versus 9.4%). Seventeen HIV seroconversions occurred; eight in participants randomized to SAVVY and nine in participants receiving placebo. The Kaplan-Meier estimates of the cumulative probability of HIV infection through 12 months were 0.010 in the SAVVY group and 0.011 in the placebo group (p = 0.731), with a hazard ratio (SAVVY versus placebo) of 0.88 (95% confidence interval 0.33, 2.27). Because of a lower-than-expected HIV incidence, we were unable to achieve the required number of HIV infections (66) to obtain the desired study power.
  
  
  CONCLUSIONS
  SAVVY was not associated with increased adverse events overall, but was associated with higher reporting of reproductive adverse events. Our data are insufficient to conclude whether SAVVY is effective at preventing HIV infection relative to placebo.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00129532.
authors: Family Health International, Durham, North Carolina, United States.
authors: Leigh
authors: L
authors: Peterson
authors: Kavita
authors: K
authors: Nanda
authors: Baafuor Kofi
authors: BK
authors: Opoku
authors: William Kwabena
authors: WK
authors: Ampofo
authors: Margaret
authors: M
authors: Owusu-Amoako
authors: Andrew Yiadom
authors: AY
authors: Boakye
authors: Wes
authors: W
authors: Rountree
authors: Amanda
authors: A
authors: Troxler
authors: Rosalie
authors: R
authors: Dominik
authors: Ronald
authors: R
authors: Roddy
authors: Laneta
authors: L
authors: Dorflinger
mesh_terms: D000287:Administration, Topical; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D005869:Ghana; D015658:HIV Infections / Q000517:prevention & control* / Q000635:transmission; D006801:Humans; D008297:Male; D010919:Placebos
chemical_list: D019380:Anti-HIV Agents; D005782:Gels; D010919:Placebos