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.

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 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 b

SUBMITTER: Feldblum PJ 

PROVIDER: S-EPMC2190795 | biostudies-literature | 2008 Jan

REPOSITORIES: biostudies-literature