16th International AIDS Conference Toronto, Canada - August 13 - 18, 2006

FINDINGS FROM A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF TENOFOVIR DISOPROXIL FUMARATE (TDF) FOR PREVENTION OF HIV INFECTION IN WOMEN

Int Conf AIDS. 2006 Aug 13-18;16 Abstract No. ThLB0103

L. Peterson¹, D. Taylor¹, E.E.K. Clarke², A.S. Doh³, P. Phillips¹, G. Belai¹, K. Nanda¹, R. Ridzon⁴, H.S. Jaffe⁵, W. Cates^1
1Family Health International, Durham, North Carolina, United States, ²Ministry of Health, Accra, Ghana, ³University of Yaoundé, Yaoundé, Cameroon, ⁴Bill & Melinda Gates Foundation, Seattle, Washington, United States, ⁵Gilead Sciences, Inc., Foster City, California, United States

BACKGROUND: Animal studies have suggested that TDF may be effective for prophylaxis against HIV infection. We investigated the safety and preliminary prophylactic effectiveness of a daily dose of 300 mg TDF versus placebo in HIV-uninfected women.

METHODS: Between June 2004 and March 2005, we enrolled 936 HIV-negative women into a double-blind, randomized trial (1:1 TDF:placebo) in Ghana, Cameroon, and Nigeria. Participants made up to 12 monthly visits for study drug re-supply, HIV testing and adverse event (AE) reporting. Laboratory testing (serum creatinine, phosphorus, ALT, and AST) was done quarterly, and ALT/AST levels were monitored in a subset of participants after study drug was withdrawn. Analysis of laboratory abnormalities was restricted to data from Ghana and Cameroon.

RESULTS: The most common AEs were malaria, candidiasis, headache, abdominal pain, and dizziness, with no significant differences between treatment groups. Furthermore, no significant differences emerged between groups for Grade 3 or higher laboratory abnormalities. Specifically, none of the 363 participants in the TDF group had ALT or AST elevations greater than 170 U/L prior to product withdrawal, and 2/368 and 3/368 of the participants in the placebo group had elevated (>170 U/L) ALT and AST levels, respectively. Two participants in the TDF group and one in the placebo group had decreases in phosphorus to less than 1.5 mg/dL. One participant in the placebo group had a creatinine elevation greater than 3.0 mg/dL. Two HIV infections were diagnosed in participants randomized to TDF (rate=0.86 per 100 person-years) and six in participants receiving placebo (rate=2.48 per 100 person-years), yielding a rate ratio of 0.35 (95% confidence interval=0.03-1.93).

CONCLUSIONS: TDF did not increase the rate of adverse events or Grade 3-4 laboratory abnormalities in participants during or after use. The number of HIV infections was insufficient to conclude that TDF protected against HIV infection.

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2006-08-13
ThLB0103

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