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MTN 007

Status
Completed
Phase
I
Principal Investigator(s)
Ian McGowan, Ken Mayer
Objective

The primary objective of this study is to assess the safety of vaginally formulated tenofovir 1% gel when applied rectally.

 

Results: Sixty-five participants (45 men and 20 women) were recruited into the study. There were no significant differences between the numbers of ≥ Grade 2 adverse events across the arms of the study. Likelihood of future product use (acceptability) was 87% (reduced glycerin formulation of tenofovir 1% gel), 93% (hydroxyethyl cellulose placebo gel), and 63% (nonoxynol-9 gel). Fecal calprotectin, rectal microflora, and epithelial sloughing did not differ by treatment arms during the study

Prevention Option(s)
Microbicides
Study Design
Controlled
Randomized
Blind
Arms and Assigned Interventions
Description
Rectal application of 2% N-9 gel
Mode of Delivery
Gel
ARMs
Experimental
Description
Rectal application of HEC placebo gel
Mode of Delivery
Gel
Products
HEC gel
ARMs
Placebo Comparator
Description
No treatment.
ARMs
Placebo Comparator
Description
rectal application of Tenofovir 1% gel
Mode of Delivery
Gel
Products
1% tenofovir gel
Trial Sponsors
CONRAD, NIAID
October 2010
July 2011
Enrollment
65
18
Years
Population
Women
Men
Sites

University of Alabama at Birmingham

Birmingham, Alabama
United States of America

Fenway Institute

Boston, Massachusetts
United States of America

University of Pittsburgh CRS

Pittsburgh, Pennsylvania
United States of America