drugset / Trial / NCT00799058

A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States

NCT00799058

Phase 1/2 Completed 128 enrolled International Partnership for Microbicides, Inc.
RandomizedParallel-groupDouble-blindPrevention

Summary

A double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the safety of dapivirine Gel 4759, 0.05% 2.5 g and dapivirine Gel 4789, 0.05% 2.5 g formulations as compared to the vaginal HEC-based Universal placebo gel, 2.5 g in healthy HIV-negative women

Timeline

Start
2009-07-06
Primary completion
2011-01-08
Completion
2011-01-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator dapivirine Small molecule 0.05 % Other
Comparator dapivirine Small molecule 2.5 g Other