Department of Psychiatry
Penn Behavioral Health

HIV/AIDS Prevention Research Division

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Microbicide Trials Unit (MTU)

Previous and Closed Studies

HIVNET 020: Phase I Vaginal Microbicide Study

HPTN 049: Phase I Safety and Acceptability Study of the Vaginal Microbicide 6% Cellulose Sulfate Gel Among HIV-Infected Women

The purpose of this study is to access the safety and acceptability of 6% cellulose sulfate (CS) gel for vaginal use versus a control gel among HIV-infected women, and to access the acceptability of CS gel among the HIV-infected male sexual partners of female participants. The study is a multi-site, Phase I, double blind, randomized, controlled frequency escalation study with 14 days of product exposure and follow-up.

HPTN 050: Phase I Safety and Acceptability Study of the Vaginal Microbicide Agent PMPA Gel

The primary objectives of this study are to assess the safety and toxicity of PMPA gel for vaginal use on vulvar and cervicovaginal mucosa and to assess the systemic absorption and toxicity of PMPA gel in assigned doses and frequency in HIV-uninfected women at low risk for HIV infection and in HIV-infected women.

The secondary objectives of this study are: (1) to assess the acceptability of, and adherence to, a short-term regimen of PMPA gel for vaginal use in low-risk, HIV- uninfected women and in HIV infected women and their male sexual partners when relevant; (2) to examine qualitative aspects of acceptability, adherence, and study burden as a pilot for substantive qualitative and quantitative assessments in future studies; (3) to measure the occurrence of vaginal shedding of HIV before and after the use of PMPA vaginal gel; (4) to measure vaginal flora characteristics before, during, and at the end of PMPA vaginal gel use, and to descriptively examine changes in these characteristics over the course of PMPA vaginal gel use.


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