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Daily-use HIV prevention approaches prove ineffective among women in NIH study
Date:3/4/2013

f the study's three product arms.

Of the 5,029 women who enrolled in the VOICE study, 312 became infected with HIV for an overall 5.7 percent rate of new HIV infections reflecting a very high overall rate of infection among women in these areas. Twenty-two women were found to be HIV-infected at time of enrollment; therefore, the study's primary analysis was based on 5,007 participants.

There was no statistically significant difference in the rate of new infections between women assigned to the three investigational products and women using placebo. Among the 994 women who were assigned to daily use of Truvada, 61 women became infected with HIV (4.7 percent rate of new infections) compared with 60 of 1,008 women who became infected in the oral placebo group (4.6 percent rate of new infections). Of the 1,002 participants in the daily oral tenofovir group, 60 women acquired HIV. However, the rate of new HIV infections was calculated to reflect what had occurred up until Oct. 3, 2011, when study sites began informing participants that testing of oral tenofovir would end. At this time, 52 women acquired HIV (6.3 percent rate of new infections) compared with 35 of 1,008 women who became infected in the placebo arm (4.2 percent rate of new infections). Of the 1,003 women assigned to use daily tenofovir gel, 61 became infected with HIV (5.9 percent rate of new infections), and 70 infections occurred among the 1,000 women in the placebo gel group (6.8 percent rate of new infections). Women who became infected with HIV during the VOICE study were referred to local sites for appropriate medical care and treatment.

During the course of the study, adherence to each of the three approaches was anticipated to be roughly 90 percent based on what study participants reported to clinic site staff and monthly counts of unused gel applicators and leftover study pills that were returned to the sites. However, in a blood sample analysis of 773 participants, in
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Contact: Kathy Stover
niaidnews@niaid.nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
Source:Eurekalert

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