Phase I Safety and Acceptability Study of the Vaginal Microbicide Agent PMPA Gel
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)
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%).