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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
SAVVY vaginal gel (C31G) for prevention of HIV infection: A randomized controlled trial in Nigeria
PLoS ONE, Volume 3, No. 1, Article e1474, Year 2008
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Description
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 qroup). 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 ot treatment effect 0.21). 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/Significance. 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. © 2008 Feldblum et al.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC2190795/bin/pone.0001474.s001.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC2190795/bin/pone.0001474.s002.doc
Authors & Co-Authors
Feldblum, Paul J.
United States, Durham
Fhi 360
Adeǐga, Adesina A.
Nigeria, Yaba
Nigerian Institute of Medical Research
Bakare, Rashidi
Nigeria, Ibadan
University of Ibadan
Wevill, Silver L.
United States, Durham
Fhi 360
Lendvay, Anja
United States, Durham
Fhi 360
Obadaki, Fatimah
Nigeria, Yaba
Nigerian Institute of Medical Research
Olayemi, M. Onikepe
Nigeria, Ibadan
University of Ibadan
Wang, Lily
United States, Durham
Fhi 360
Nanda, Kavita
United States, Durham
Fhi 360
Roundtree, Wes
United States, Durham
Fhi 360
Statistics
Citations: 291
Authors: 10
Affiliations: 3
Identifiers
Doi:
10.1371/journal.pone.0001474
e-ISSN:
19326203
Research Areas
Disability
Environmental
Health System And Policy
Infectious Diseases
Sexual And Reproductive Health
Study Design
Cohort Study
Quasi Experimental Study
Study Approach
Quantitative
Study Locations
Nigeria
Participants Gender
Male
Female