Details
Protocol Title:
Phase 1 rectal microbicide safety and acceptability trial of topically applied tenofovir compared with oral tablet
DAIDS Protocol ID:
10769
Status:
Participants off Study and Primary Analysis Completed
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.
Other Study Info
Sponsors:
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US National Institutes of Health
Co-Sponsors:
CONRAD, Gilead Sciences, Inc..
Study design:
Phase 1, randomized, two-site, partially-blinded, placebo controlled study
