Abstract | OBJECTIVES: 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: RESULTS: Study participants contributed 428 person-years of laboratory testing to the primary safety analysis. No significant differences emerged between treatment groups in clinical or laboratory safety outcomes. Study participants contributed 476 person-years of HIV testing to the primary effectiveness analysis, during which time eight seroconversions occurred. Two were diagnosed in participants randomized to TDF (0.86 per 100 person-years) and six in participants receiving placebo (2.48 per 100 person-years), yielding a rate ratio of 0.35 (95% confidence interval = 0.03-1.93), which did not achieve statistical significance. Owing to premature closures of the Cameroon and Nigeria study sites, the planned person-years of follow-up and study power could not be achieved. CONCLUSION: Daily oral use of TDF in HIV-uninfected women was not associated with increased clinical or laboratory adverse events. Effectiveness could not be conclusively evaluated because of the small number of HIV infections observed during the study.
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Authors | Leigh Peterson, Doug Taylor, Ronald Roddy, Ghiorghis Belai, Pamela Phillips, Kavita Nanda, Robert Grant, Edith Essie Kekawo Clarke, Anderson Sama Doh, Renee Ridzon, Howard S Jaffe, Willard Cates |
Journal | PLoS clinical trials
(PLoS Clin Trials)
Vol. 2
Issue 5
Pg. e27
(May 25 2007)
ISSN: 1555-5887 [Electronic] England |
PMID | 17525796
(Publication Type: Journal Article)
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