Microbicide Trials Network

MTN-007

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: 
Participants off Study and Primary Analysis Completed

Protocol Chair(s)

Kenneth Mayer (Protocol Co-Chair)
Ian McGowan (Protocol Chair)

Description

MTN-007 was a Phase 1, randomized, blinded, placebo-controlled safety and acceptability study of tenofovir RG 1% gel when applied rectally. This study also examined whether rectal use of tenofovir RG 1% gel was associated with rectal mucosal damage using a broad range of immunological safety biomarkers. Nonoxynol-9 (N-9) 2% gel was used as a positive control for mucosal damage as rectal application of 2% N-9 was previously shown  to cause mild but transient mucosal damage. Other secondary objectives included evaluations of the acceptabilitSally Morrowy of rectal administration of tenofovir RG 1% gel as well as the safety of HEC placebo gel when applied rectally.

 

Recruitment began in late 2010 and ended in mid-2011 with 60 enrolled. Participants were randomized to receive a single dose of tenofovir RG 1% gel, 2% N-9 gel, placebo gel, or  no treatment, to be self-administered under observation. Within approximately 30 minutes, lavage, stool, and rectal biopsy specimens were collected. After a one-week recovery period, participants returned to the clinic for assessment. If no significant adverse events (AEs) were reported, participants began to self-administer once-daily doses of the study gel for 7 days on an outpatient basis. Participants returned to the clinic for evaluation and specimen collection after completion of 7 days of daily dosing. MTN-007 results were initially presented at the annual Conference on Retroviruses and opportunistic Infections (CROI) held on March 5-8, 2012 in Seattle, WA.

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