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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
SAVVY® (C31G) gel for prevention of HIV infection in women: A phase 3, double-blind, randomized, placebo-controlled trial in Ghana
PLoS ONE, Volume 2, No. 12, Article e1312, Year 2007
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Description
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 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/Significance. 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. © 2007 Peterson et al.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC2129116/bin/pone.0001312.s001.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC2129116/bin/pone.0001312.s002.doc
Authors & Co-Authors
Peterson, Leigh
Unknown Affiliation
Nanda, Kavita
Unknown Affiliation
Opoku, Baafour Kofi
Unknown Affiliation
Ampofo, William Kwabena
Unknown Affiliation
Owusu-Amoaka, Margaret
Unknown Affiliation
Boakye, Andrew
Unknown Affiliation
Rountree, Wes
Unknown Affiliation
Troxler, Amanda
Unknown Affiliation
Dominik, Rosalie C.
Unknown Affiliation
Roddy, Ronald E.
Unknown Affiliation
Dorflinger, Laneta J.
Unknown Affiliation
Statistics
Citations: 209
Authors: 11
Affiliations: 5
Identifiers
Doi:
10.1371/journal.pone.0001312
e-ISSN:
19326203
Research Areas
Disability
Environmental
Health System And Policy
Infectious Diseases
Sexual And Reproductive Health
Study Design
Cohort Study
Study Locations
Ghana
Participants Gender
Male
Female