SAVVY Vaginal Gel (C31G) for Prevention of HIV Infection A Randomized Controlled Trial in Nigeria 英文参考文献.docVIP

SAVVYVaginalGel(C31G)forPreventionofHIV Infection:ARandomizedControlledTrialinNigeria PaulJ.Feldblum1*,AdesinaAdeiga2,RashidiBakare3,SilverWevill1,AnjaLendvay1,FatimahObadaki2,M.OnikepeOlayemi3,LilyWang1 ,Kavita Nanda1,WesRountree1 1FamilyHealthInternational,ResearchTrianglePark,NorthCarolina,UnitedStates,2NigerianInstituteofMedicalResearch,Lagos,Nigeria,3College ofMedicine,UniversityofIbadan,Ibadan,Nigeria Background.Theobjectiveofthistrialwastodeterminetheeffectivenessof1.0%C31G(SAVVY)inpreventingmale-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, adverseeventreporting,andstudyproductsupply.ThestudywasconductedbetweenSeptember2004andDecember2006in Lagos and Ibadan, Nigeria, where we enrolled 2153 HIV-negative women at high risk of HIV infection. Participants were randomized1:1toSAVVYorplacebo.TheeffectivenessendpointwasincidenceofHIVinfectionasindicatedbydetectionof HIV antibodies in oral mucosal transudate (rapid test) or blood (ELISA), and confirmed by Western blot or PCR testing. We observed33seroconversions(21intheSAVVYgroup,12intheplacebogroup).TheKaplan-Meierestimatesofthecumulative probabilityofHIVinfectionat12monthswere0.028intheSAVVYgroupand0.015intheplacebogroup(2-sidedp-valuefor the log-rank testoftreatment effect0.121). Thepoint estimate ofthe hazard ratiowas 1.7forSAVVYversus placebo(95% confidenceinterval0.9,3.5).Becauseoflower-than-expectedHIVincidence,wedidnotobservetherequirednumberofHIV infections(66)foradequatepowertodetectaneffectofSAVVY.Follow-upfrequenciesofadverseevents,reproductivetract adverseevents,abnormalpelvicexaminationfindings,chlamydialinfectionsandvaginalinfectionsweresimilarinthestudy arms. No serious adverse event was attributable to SAVVY use. Conclusions/Significance. SAVVY did not reduce the incidenceofHIVinfection.Althoughtheh