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. The primary manuscript was published in PLoS One on April 3, 2013.
US National Institute of Mental Health
US National Institutes of Health
Phase 1 randomized, double-blinded, multi-site, placebo-controlled trial