drugset / Trial / NCT02033109

Safety, Pharmacokinetics and Acceptability of PC-1005 for Vaginal Use

NCT02033109 ↗

Phase 1 Completed 35 enrolled Population Council
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This Phase 1 clinical trial will evaluate MIV-150, a third generation non-nucleoside reverse transcriptase inhibitor, co-formulated with a potentially potent agent, zinc acetate for the prevention of HIV infection in women. This is the first in-human of PC-1005 (MIV-150/zinc acetate in a carrageenan gel), the first study in which females will be exposed to MIV-150, the first time MIV-150 will be administered topically, and the first time MIV-150 will be administered intravaginally.

Timeline

Start
2014-05
Primary completion
2015-04
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Subject PC-1005 Unknown 4 g Other