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Major HIV prevention trial in women to drop oral tenofovir arm
Date:9/28/2011

h product works compared to its control (placebo gel or placebo tablet) and which approach women prefer.

On September 16, 2011, the NIAID Prevention Trials DSMB reviewed VOICE study data for the period between Sept. 9, 2009, when the study began, and July 1, 2011. Based on this interim review, the DSMB determined that it was not possible to show whether oral tenofovir tablets were any better than a placebo for preventing HIV in the women assigned to that study group. The DSMB therefore recommended that the women randomized to the oral tenofovir tablet group discontinue their use of the study product. This recommendation does not apply to the women in the groups using either the tenofovir gel or oral Truvada tablets, or the corresponding placebos; the DSMB recommended that these four study groups continue in VOICE.

All VOICE participants will be informed about the decision to modify the study. Because the DSMB had no concerns about the safety of oral tenofovir, the process of discontinuing its use among the participants in that study group can proceed in an orderly fashion. Each of these participants will stop using the oral tenofovir tablets at their next scheduled clinic appointment. They will then return eight weeks later for a last set of tests and procedures before exiting the study. The participants will be provided with information about where they can receive HIV testing and counseling, contraception and other medical or support services as needed. Women in the oral tenofovir group who became HIV-infected and/or pregnant during VOICE and are enrolled in an MTN ancillary study may continue to participate in these studies.

The investigators, led by Zvavahera Mike Chirenje, M.D., of the University of Zimbabwe in Harare, and Jeanne Marrazzo, M.D., M.P.H., from the University of Washington in Seattle, U.S., expressed their disappointment that oral tenofovir did not reduce HIV infection in participants receiving it, but noted that the obj
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Contact: Lisa Rossi
rossil@upmc.edu
412-916-3315
Microbicide Trials Network
Source:Eurekalert

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