Details
Protocol Title:
A Phase 1 Randomized, Double-Blinded, Placebo-Controlled Rectal Safety and Acceptability Study of Tenofovir 1% Gel
DAIDS Protocol ID:
10736
Status:
Closed to Follow Up
Description
MTN-007 is a Phase I, randomized, blinded, placebo-controlled safety and acceptability study of tenofovir 1% gel when applied rectally. Participants will be randomized to receive a single dose of tenofovir 1% gel, 2% N-9 gel or a placebo gel that is applied by a clinician at the study site. Participants will return to the clinic one week later, where they will be given a 7-day supply of the study gel. The study will enroll approximately 63 men and women at domestic sites.
Other Study Info
Study Design:
Phase 1 randomized, double-blinded, multi-site, placebo-controlled trial
Sponsors:
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US National Institute of Mental Health
US National Institutes of Health
Co-Sponsor:
CONRAD
