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Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women.

dc.contributor.authorAbdool Karim, Salim Safurdeen.
dc.contributor.authorAbdool Karim, Quarraisha.
dc.contributor.authorFröhlich, Janet Ann.
dc.contributor.authorGrobler, Anna Christina.
dc.contributor.authorBaxter, Cheryl.
dc.contributor.authorMansoor, Leila Essop.
dc.contributor.authorKharsany, Ayesha Bibi Mahomed.
dc.contributor.authorSibeko, Sengeziwe.
dc.contributor.authorMlisana, Koleka Patience.
dc.contributor.authorOmar, Zaheen.
dc.contributor.authorGengiah, Tanuja Narayansamy.
dc.contributor.authorMaarschalk, Silvia.
dc.contributor.authorArulappan, Natasha.
dc.contributor.authorMlotshwa, Mukelisiwe.
dc.contributor.authorMorris, Lynn.
dc.contributor.authorTaylor, Douglas.
dc.date.accessioned2012-11-29T06:09:55Z
dc.date.available2012-11-29T06:09:55Z
dc.date.created2010
dc.date.issued2010
dc.description.abstractThe Centre for the AIDS Program of Research in South Africa (CAPRISA) 004 trial assessed the effectiveness and safety of a 1% vaginal gel formulation of tenofovir, a nucleotide reverse transcriptase inhibitor, for the prevention of HIV acquisition in women. A double-blind, randomized controlled trial was conducted comparing tenofovir gel (n = 445 women) with placebo gel (n = 444 women) in sexually active, HIV-uninfected 18- to 40-year-old women in urban and rural KwaZulu-Natal, South Africa. HIV serostatus, safety, sexual behavior, and gel and condom use were assessed at monthly follow-up visits for 30 months. HIV incidence in the tenofovir gel arm was 5.6 per 100 women-years (person time of study observation) (38 out of 680.6 women-years) compared with 9.1 per 100 women-years (60 out of 660.7 women-years) in the placebo gel arm (incidence rate ratio = 0.61; P = 0.017). In high adherers (gel adherence > 80%), HIV incidence was 54% lower (P = 0.025) in the tenofovir gel arm. In intermediate adherers (gel adherence 50 to 80%) and low adherers (gel adherence < 50%), the HIV incidence reduction was 38 and 28%, respectively. Tenofovir gel reduced HIV acquisition by an estimated 39% overall, and by 54% in women with high gel adherence. No increase in the overall adverse event rates was observed. There were no changes in viral load and no tenofovir resistance in HIV seroconverters. Tenofovir gel could potentially fill an important HIV prevention gap, especially for women unable to successfully negotiate mutual monogamy or condom use.en
dc.identifier.citationAbdool Karim, Q. et al. 2010. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science 329 (5996), pp. 1168-1174.en
dc.identifier.issn0036-8075
dc.identifier.urihttp://dx.doi.org/10.1126/science.1193748en
dc.identifier.urihttp://hdl.handle.net/10413/8038
dc.language.isoenen
dc.publisherAmerican Association for the Advancement of Science.en
dc.subjectAIDS (Disease) in women--Prevention.en
dc.subjectAntiretroviral agents.en
dc.subjectHIV infections--Prevention.en
dc.subject.otherTenofovir gel.en
dc.titleEffectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women.en
dc.typePeer reviewed journal articleen

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