Details
- Protocol Title
- Phase 1 rectal microbicide safety and acceptability trial of topically applied tenofovir compared with oral tablet
- DAIDS Protocol ID
- 10769
- Status
- Closed to follow Up
Description
RMP-02/MTN-006 will evaluate the safety and early pharmacokinetic profile of 1% vaginally-formulated tenofovir gel, applied rectally, during a single exposure followed by once-daily dosing for 7 days. This will be compared to a single oral dose. This study is designed as a Phase 1 rectal safety trial to support the vaginal microbicide application, should vaginal efficacy be demonstrated. Independently, this agent is being assessed for its safety as a rectal microbicide for use by men and women.