Journal article

Safety of tenofovir gel, a vaginal microbicide, in South African women: results of the CAPRISA 004 Trial

David C Sokal, Quarraisha Abdool Karim, Sengeziwe Sibeko, Nonhlanhla Yende-Zuma, Leila E Mansoor, Cheryl Baxter, Anneke Grobler, Janet Frolich, Ayesha BM Kharsany, Nomsa Miya, Koleka Mlisana, Silvia Maarshalk, Salim S Abdool Karim

ANTIVIRAL THERAPY | INT MEDICAL PRESS LTD | Published : 2013

Abstract

BACKGROUND: Tenofovir gel, used vaginally before and after coitus, reduced women's acquisition of HIV by 39%. This is a safety assessment of tenofovir gel, including renal, bone, gastrointestinal, genital and haematological parameters. METHODS: In the Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004, a double-blind, randomized placebo-controlled trial, 445 of the 889 eligibly enrolled women were assigned to tenofovir gel. All participants were advised to use the gel vaginally only, with one dose of gel within 12 h before and a second dose as soon as possible after sex, with no more than two doses in 24 h. Clinical and laboratory safety data were collected at monthly an..

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