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American Association for the Advancement of Science, Science, 5996(329), p. 1168-1174, 2010

DOI: 10.1126/science.1193748

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Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women

Journal article published in 2010 by Quarraisha Abdool Karim, Gengiah Tn, Quarraisha Abdool Karim, S. S. A. Karim, Abdool Karim Ss, Salim S. Abdool Karim, Janet A. Frohlich, Anneke C. Grobler ORCID, Frohlich Ja, Cheryl Baxter ORCID, Grobler Ac, Leila E. Mansoor, Ayesha B. M. Kharsany, Mansoor Le, Sengeziwe Sibeko and other authors.
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Abstract

The 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