HPTN 050
Phase I Safety and Acceptability Study of the Vaginal Microbicide Agent PMPA Gel
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What was HPTN 050?
Phase I multisite stepped parallel dose and frequency study to determine the safety and acceptability of PMPA gel for vaginal use among sexually abstinent and sexually active HIV-uninfected, and HIV-infected women; and to determine the acceptability of PMPA gel among their male sexual partners (when relevant).
Who participated in the study?
Up to 72 HIV-uninfected women (up to 60 sexually abstinent and up to 12 sexually active), up to 24 HIV-infected women (up to 12 sexually abstinent and up to 12 sexually active) and up to 24 male sexual partners (12 HIV-uninfected and 12 HIV-infected)
What happened during the study?
Female participants in cohorts A – D applied PMPA gel intravaginally for 14 intramenstrual days and participants in cohort V (if required) applied the vehicle only as follows: (see protocol for regimen table)
Results
The gel was found to be highly acceptable to most men, the large majority indicating they would probably use it in the future if they were concerned about HIV and the product were available. The 1% tenofovir gel used twice daily was as well tolerated as other regimens used by the 48 HIV-negative sexually abstinent women, establishing the HPDF. Although 92% of the women reported at least one adverse event, the majority were mild (87%) and involved the genitourinary tract (70%).
Protocol Status
Concluded
Study Purpose
To determine the safety and acceptability of PMPA gel for vaginal use among sexually abstinent and sexually active HIV-uninfected, and HIV-infected women; and to determine the acceptability of PMPA gel among their male sexual partners (when relevant).
Study Design
Phase I multisite stepped parallel dose and frequency study with 14 days of product exposure and up to 21 days of follow-up for each female participant.
Study Population
Up to 72 HIV-uninfected women (up to 60 sexually abstinent and up to 12 sexually active), up to 24 HIV-infected women (up to 12 sexually abstinent and up to 12 sexually active) and up to 24 male sexual partners (12 HIV-uninfected and 12 HIV-infected)
Study Size
Up to 96 women and up to 24 men will be enrolled
Study Duration
Accrual will require 11 months. Each participant will be followed for up to 21 days. Acceptability interviews will be convened within four weeks after the completion of product use and follow-up. Therefore the entire study should be completed within 13 months.
Treatment Regime
Female participants in cohorts A – D will apply PMPA gel intravaginally for 14 intramenstrual days and participants in cohort V (if required) will apply vehicle only as follows: (see protocol for regimen table)
Primary Objectives
To assess the safety and toxicity of PMPA gel for vaginal use in assigned doses and frequency on vulvar and cervicovaginal mucosa in HIV-uninfected women at low risk for HIV infection as well as in HIV-infected women.
To assess the systemic safety and absorption of PMPA gel for vaginal use in low-risk, HIV uninfected women as well as in HIV infected women.
Secondary Objectives
To assess the acceptability of, and adherence to, a short-term regimen of PMPA gel for vaginal use in low-risk, HIV-uninfected women as well as in HIV infected women and their male sexual partners (when relevant).
To examine qualitative aspects of acceptability and adherence as a pilot for substantive qualitative and quantitative assessments in future studies.
Exploratory Objectives:To measure the occurrence of vaginal shedding of HIV before and after use of PMPA gel for vaginal use.
To assess the genotypic resistance patterns of HIV in genital secretions and blood samples from the HIV-infected female participants of the course of PMPA vaginal gel use.
To measure changes in vaginal flora before and after use of PMPA gel for vaginal use using the Nugent Scoring System
Other Objectives
Study Documents
Providence, United States
2951