SAVVY vaginal gel (C31G) for prevention of HIV infection: a randomized controlled trial in Nigeria.

PloS One
Paul J FeldblumWes Rountree

Abstract

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. 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 incid...Continue Reading

Associated Clinical Trials

References

Jul 22, 1992·JAMA : the Journal of the American Medical Association·J KreissT R Fleming
Jun 1, 1988·AIDS Research and Human Retroviruses·A Roumelioutou-KarayannisG Papaevangelou
Aug 1, 1994·AIDS·C F Caceres, G J van Griensven
Nov 22, 2002·Contraception·R BaxM Bowden
Nov 22, 2002·Contraception·S A BallaghD F Archer
Aug 25, 2004·Contraception·Christine K MauckRichard Bax
Aug 25, 2004·Contraception·Christine K MauckRichard Bax
Jun 23, 2006·The New England Journal of Medicine·Markus J Steiner, Willard Cates
Mar 6, 2007·Lancet·Jan Balzarini, Lut Van Damme
Jul 11, 2007·Sexually Transmitted Diseases·Elizabeth G RaymondBrooke R Johnson
Aug 11, 2007·American Journal of Obstetrics and Gynecology·Mark A Klebanoff

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Citations

Apr 3, 2012·Therapeutic Delivery·Lindsay M Ferguson, Lisa Cencia Rohan
Jan 11, 2014·Clinical Investigation·Melanie R NicolAngela Dm Kashuba
Nov 22, 2011·Future Medicinal Chemistry·Joanna S OlsenStephen Dewhurst
Mar 20, 2014·AIDS and Behavior·Leila Essop MansoorSalim S Abdool Karim
Jun 11, 2008·Psychosomatic Medicine·Nancy KlimasMary Ann Fletcher
Sep 22, 2011·Obstetrics and Gynecology·Sengeziwe SibekoSalim S Abdool Karim
Apr 3, 2008·The Journal of Clinical Investigation·Myron S CohenJoep Lange
Jul 16, 2008·Emerging Themes in Epidemiology·Helen A WeissLaith J Abu-Raddad
Jul 26, 2008·Science·Robert M GrantMark A Wainberg
Jun 18, 2009·Current Opinion in HIV and AIDS·Sten H VermundQuarraisha Abdool Karim
Jun 25, 2009·BMC Medical Research Methodology·Vera HalpernNeha Mehta
Jul 10, 2009·The Journal of Infectious Diseases·Pedro M M MesquitaBetsy C Herold
Oct 13, 2009·Emerging Themes in Epidemiology·Benoît R MâsseKamal Desai
Feb 25, 2010·AIDS·Nancy S PadianJudith N Wasserheit
Apr 7, 2010·Current Infectious Disease Reports·Lucio R Minces, Ian McGowan
Nov 5, 2010·International Journal of Epidemiology·Quarraisha Abdool KarimSalim S Abdool Karim
Nov 23, 2010·BMC Infectious Diseases·Thomas R MoenchRichard A Cone
Feb 19, 2011·AIDS·Salim S Abdool KarimUNKNOWN HIV Prevention Trials Network (HPTN) 035 Study Team
Feb 25, 2011·European Journal of Medical Research·T Mertenskoetter, Paulina E Kaptur
Mar 29, 2011·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Sally L HodderUNKNOWN HIV Prevention Trials Network Domestic Prevention in Women Working Group
Mar 23, 2011·Current HIV/AIDS Reports·Natasha A VermaMarla J Keller
Aug 13, 2011·Infectious Diseases in Obstetrics and Gynecology·Andrea Ries ThurmanGustavo F Doncel
Oct 14, 2011·Sexually Transmitted Diseases·Lauren L KatzenBarbara S Mensch
Feb 9, 2012·The Indian Journal of Medical Research·Gita Ramjee
Feb 9, 2012·The Indian Journal of Medical Research·UNKNOWN Nutan, Satish K Gupta
Jan 22, 2013·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Barbra A RichardsonUNKNOWN HPTN 035 Study Team

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Methods Mentioned

BETA
enzyme-linked immunosorbent assay
ELISA
PCR
pregnancy test

Software Mentioned

OraQuick

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