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Charting the Course of the First Phase II Rectal Microbicide Trial

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Wednesday, February 29, 2012

Last month the Microbicide Trial Network (MTN), in partnership with AVAC and other groups (see below for full list), held community consultations in Chiang Mai and Bangkok on the planned MTN-017 trial of a rectal formulation of 1% tenofovir gel. These consultations were organized in partnership with advocates who have worked with AVAC on implementing Good Participatory Practice guidelines in Thailand. MTN-017 plans to enroll approximately 216 participants, men who have sex with men and transgender women, at trial sites in South Africa, Peru, Thailand and the United States. Results of the Phase II safety trial will be used to guide decisions on future efficacy trials of the gel as an HIV prevention tool for use during anal sex. At the meetings in Chiang Mai and Bangkok, community stakeholders emphasized the importance of gathering data on rectal use of 1% tenofovir gel among transgender women. As a result of this feedback, the trial team decided to amend the protocol to include transgender women as trial participants—an example of GPP in action!

The full group of collaborators included the International Rectal Microbicide Advocates (IRMA), the Thai Ministry of Public Health – US Centers for Disease Control and Prevention Collaboration and the Thai Research Institute for Health Sciences (RIHES) along with MTN and AVAC. MTN-017 consultations were also held in South Africa in October 2011 and are planned for Peru in March 2012. Contact avac@avac.org to learn more.

Background facts: The rectal formulation of 1% tenofovir gel was developed to address results from an earlier study, RMP-02/MTN-006, which found that while the vaginal formulation of 1% tenofovir gel used in CAPRISA 004, VOICE and FACTS 001 was generally safe to use in the rectum, side effects were problematic to a few study participants. A rectal formulation of the gel was subsequently developed and tested in MTN-007, the results of which will be reported at CROI in March of this year.