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

ective of the study was to answer questions about each of the approaches. Researchers don't know why the tenofovir tablet was not effective in the study's population predominately women in their 20's (and younger) who may or may not be married or in a committed relationship and are living in communities where HIV incidence is among the highest. Meanwhile, the team remains committed to completing the trial and to providing evidence on whether oral Truvada and/or tenofovir gel are effective in reducing the risk of HIV infection among young women.

The team is especially grateful to all of the VOICE participants, whose commitment to this trial has already helped in gaining insight about oral tenofovir tablets for preventing HIV among women. This information will have significant implications for a field that faces important decisions about the use of oral PrEP and in which particular populations it could have the most benefit.

No additional information about the independent DSMB's decision is available at this time. Once the study is completed, which is expected to be before the end of 2012, a full analysis of all data will be conducted.

A DSMB is an independent group of clinical research experts, statisticians, ethicists and often community representatives that provides additional oversight to a clinical study. A DSMB regularly reviews blinded data not available to the investigators or anyone else, while a clinical trial is in progress. Based on its review of interim data, a DSMB may, at any time, recommend that a trial, or part of a trial, be stopped if there are concerns about safety, compelling evidence for a product's effectiveness or if it becomes clear that the trial cannot show that a product is effective, a concept called futility.

Since the study began in September 2009, the NIAID Prevention Trials DSMB has conducted five periodic reviews of VOICE interim data. All reviews prior to the 16 September review indicated no conc
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Contact: Lisa Rossi
rossil@upmc.edu
412-916-3315
Microbicide Trials Network
Source:Eurekalert

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