HPTN 035
Phase II/IIb Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and 0.5% PRO2000/5 Gel (P) for the Prevention of HIV Infection in Women
External Evaluation
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.
| Introduction | Salim Abdool-Karim | |
| HPTN 035 Placebo Gel | Tom Moench | |
| Microbicide Study Design Issues | Tom Fleming | |
| HPTN 035 Protocol Overview | Salim Abdool-Karim | |
| Feasibility of Implementation | Anne Coletti | |
| Conclusion | Ward Cates | |
