Tenofovir disoproxil fumarate for prevention of HIV infection in women: a phase 2, double-blind, randomized, placebo-controlled trial.

ABSTRACT:

Objectives

The objective of this trial was to investigate the safety and preliminary effectiveness of a daily dose of 300 mg of tenofovir disoproxil fumarate (TDF) versus placebo in preventing HIV infection in women.

Design

This was a phase 2, randomized, double-blind, placebo-controlled trial.

Setting

The study was conducted between June 2004 and March 2006 in Tema, Ghana; Douala, Cameroon; and Ibadan, Nigeria.

Participants

We enrolled 936 HIV-negative women at high risk of HIV infection into this study.

Intervention

Participants were randomized 1:1 to once daily use of 300 mg of TDF or placebo.

Outcome measures

The primary safety endpoints were grade 2 or higher serum creatinine elevations (>2.0 mg/dl) for renal function, grade 3 or 4 aspartate

SUBMITTER: Peterson L 

PROVIDER: S-EPMC1876601 | biostudies-literature | 2007 May

REPOSITORIES: biostudies-literature