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

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Abdool Karim, Quarraisha, Abdool Karim, Salim S., Frohlich, Janet A., Grobler, Anneke C., Baxter, Cheryl, Mansoor, Leila E., Kharsany, Ayesha B. M., Sibeko, Sengeziwe, Mlisana, Koleka P., Omar, Zaheen, Gengiah, Tanuja N., Maarschalk, Silvia, Arulappan, Natasha, Mlotshwa, Mukelisiwe, Morris, Lynn, Taylor, Douglas, on behalf of the CAPRISA 004 Trial Group·2010·Science

DOI 10.1126/science.1193748PMC PMC3001187

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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 < 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.

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Authors: Abdool Karim, Q., Abdool Karim, S. S., Frohlich, J. A., Grobler, A. C., Baxter, C., Mansoor, L. E., Kharsany, A. B. M., Sibeko, S., Mlisana, K. P., Omar, Z., Gengiah, T. N., Maarschalk, S., Arulappan, N., Mlotshwa, M., Morris, L., Taylor, D., & on behalf of the CAPRISA 004 Trial Group
Affiliations: Centre for the AIDS Program of Research in South Africa (CAPRISA), Durban 4013, South Africa.
Centre for the AIDS Programme of Research in South Africa (ZA)
National Institute for Communicable Diseases (ZA)
Family Health International 360 (US)
ORCID: Grobler, Anneke C.
Baxter, Cheryl
Mansoor, Leila E.
Kharsany, Ayesha B. M.
Sibeko, Sengeziwe
Mlisana, Koleka P.
Gengiah, Tanuja N.
Arulappan, Natasha
Morris, Lynn
Taylor, Douglas
Venue: Science
Publisher: American Association for the Advancement of Science (AAAS)
Published: 2010-09-03
Volume: 329
Issue: 5996
Pages: 1168-1174
ISSN: 0036-8075 (ISSN-L)
1095-9203
DOI: 10.1126/science.1193748
PMC: PMC3001187
OpenAlex: W2146634980
Cited by: 2,435
References: 33
Citations by year: 2026: 13 · 2025: 27 · 2024: 29 · 2023: 27 · 2022: 43 · 2021: 81 · 2020: 65 · 2019: 81 · 2018: 106 · 2017: 150 · 2016: 182 · 2015: 212 · 2014: 292 · 2013: 328 · 2012: 385
FWCI: 229.92
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: Science (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Figshare (submittedVersion, cc-by)
ResearchSpace (University of KwaZulu-Natal) (submittedVersion)
Columbia Academic Commons (Columbia University)
Funders: National Institute of Allergy and Infectious Diseases (U01AI046749, U01AI068633, U19AI051794, U01AI068619, AI 51794)
Fogarty International Center (D43TW000231)
Topics: Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
Life Sciences › Immunology and Microbiology › Virology › HIV Research and Treatment
Keywords: tenofovir gel, HIV prevention, microbicides, vaginal gel, women, HIV incidence, antiretroviral drugs, nucleotide reverse transcriptase inhibitors, HIV seroconversion, tenofovir resistance, sexual behavior, condom use
MeSH terms: Tenofovir, Adenine, Administration, Intravaginal, Adolescent, Adult, Anti-Infective Agents, Local, Double-Blind Method, Female, Humans, Patient Compliance, Pregnancy, Pregnancy Outcome, Rural Population, Sexual Behavior, South Africa, Urban Population, Vaginal Creams, Foams, and Jellies, HIV-1, HIV Infections, Incidence, Anti-HIV Agents, Viral Load, Drug Resistance, Viral, Young Adult, Organophosphonates

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

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