Tenofovir

Effectiveness and Safety of Tenofovir Gel an Antiretroviral Microbicide

The CAPRISA 004 trial assessed 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 with placebo gel in sexually active, HIVuninfected18 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.

Preventing Prevention Trial Failures: A case study and lessons for future trials from the 2004 Tenofovir trial in Cambodia

This document is published by the Global Campaign for Microbicides and is based on interviews conducted in Cambodia and by telephone from mid-2006 through 2008 with key players in the events surrounding the 2004 trial to determine whether tenofovir disoproxil fumarate was safe and effective for use as a pre-exposure chemoprophylaxis to prevent HIV transmission. Before the trial formally began, preparations for it were halted by the Cambodian government following protests led by the Women’s Network for Unity (WNU), the union of Cambodian sex workers.

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