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Safety and effectiveness of BufferGel and 0.5% PRO 2000 gel for the prevention of HIV infection in women.

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dc.contributor.authorAbdool Karim, Salim Safurdeen.
dc.contributor.authorRichardson, Barbra Ann.
dc.contributor.authorRamjee, Gita.
dc.contributor.authorHoffman, Irving F.
dc.contributor.authorChirenje, Zvavahera Mike.
dc.contributor.authorTaha, Taha E.
dc.contributor.authorKapina, Muzala.
dc.contributor.authorMaslankowski, Lisa.
dc.contributor.authorColetti, Anne S.
dc.contributor.authorProfy, Albert.
dc.contributor.authorMoench, Thomas R.
dc.contributor.authorPiwowar-Manning, Estelle.
dc.contributor.authorMasse, Benoit.
dc.contributor.authorHillier, Sharon Louise.
dc.contributor.authorSoto-Torres, Lydia.
dc.date.accessioned2012-11-15T07:01:12Z
dc.date.available2012-11-15T07:01:12Z
dc.date.created2010
dc.date.issued2010
dc.descriptionResults of the HPTN 035 trial. Abstract 48LB (16th Conference on Retroviruses and Opportunistic Infections, 2009).en
dc.description.abstractObjective: To determine the safety and effectiveness of BufferGel and 0.5% PRO2000 microbicide gels for the prevention of male-to-female HIV transmission. Design: Phase II/IIb, randomized, placebo-controlled trial with three double-blinded gel arms and an open-label no gel arm. Methods: Study participants from Malawi, South Africa, Zambia, Zimbabwe, and the USA were instructed to apply study gel up to 1 h before each sex act and safety, sexual behavior, pregnancy, gel adherence, acceptability, and HIV serostatus were assessed during follow-up. Results: The 3101 enrolled women were followed for an average of 20.4 months with 93.6% retention and 81.1% self-reported gel adherence. Adverse event rates were similar in all study arms. HIV incidence rates in the 0.5% PRO2000 gel, BufferGel, placebo gel, and no gel arms were 2.70, 4.14, 3.91, and 4.02 per 100 women-years, respectively. HIV incidence in the 0.5% PRO2000 gel arm was lower than the placebo gel arm (hazard ratio = 0.7, P=0.10) and the no gel arm (hazard ratio = 0.67, P=0.06). HIV incidence rates were similar in the BufferGel and both placebo gel (hazard ratio =1.10, P=0.63) and no gel control arms (hazard ratio =1.05, P=0.78). HIV incidence was similar in the placebo gel and no gel arms (hazard ratio =0.97, P=0.89). Conclusion: The 0.5% PRO2000 gel demonstrated a modest 30% reduction in HIV acquisition in women. However, these results were not statistically significant and subsequent findings from the Microbicide Development Programme (MDP) 301 trial have confirmed that 0.5% PRO2000 gel has little or no protective effect. BufferGel did not alter the risk of HIV infection. Both products were well tolerated.en
dc.identifier.citationAbdool Karim, S.S. et al. 2011. Safety and effectiveness of vaginal microbicides BufferGel and 0.5% PRO 2000/5 gel for the prevention of HIV infection in women. Aids 25(7), pp. 957-966.en
dc.identifier.issn0269-9370
dc.identifier.urihttp://dx.doi.org/10.1097/QAD.0b013e32834541d9en
dc.identifier.urihttp://hdl.handle.net/10413/7854
dc.publisherLippincott Williams & Wilkins.en
dc.subjectClinical trials.en
dc.subjectHIV infections--Prevention.en
dc.subjectHIV infections--Transmission.en
dc.subject.otherBufferGel.en
dc.subject.otherMicrobicide.en
dc.subject.otherPRO 2000 gel.en
dc.titleSafety and effectiveness of BufferGel and 0.5% PRO 2000 gel for the prevention of HIV infection in women.en
dc.typePeer reviewed journal articleen

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