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External Scientific Review
of
HPTN 035: Phase II/IIb Safety and Effectiveness Study of the Vaginal
Microbicides BufferGel and 0.5% PRO 2000/5 Gel (P) for the Prevention of
HIV Infection in Women
As many HIV Prevention Trials Network
members were made aware at the HPTN Annual meeting this past February, the
Division of AIDS requested that an external scientific review of HPTN 035
be convened prior to deciding whether to provide funding to conduct the HPTN 035 study. The review was convened on 15 May 2003, with the objective
of determining whether to invest significant resources to test the
selected candidate microbicide products to be tested in HPTN 035, using
the design specified in the HPTN 035 protocol. The review also assessed
the feasibility of conducting the study as designed.
The HPTN is pleased to report that the
External Scientific Review Committee endorsed implementation of HPTN 035
as designed. Therefore, further development of the study protocol is now
proceeding. For more information on the current draft HPTN 035 protocol,
please contact Anne Coletti at acoletti@fhi.org.
The slide presentations made by HPTN 035
team members to the External Scientific Review Committee are available
through the links below. Excluded from these presentations is proprietary
product information that is not currently available in the public domain.
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