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RMP 02/MTN 006

Status
Completed
Phase
I
Principal Investigator(s)
Peter Anton
Objective

The primary objective of this study is to evaluate the systemic safety of 1% vaginally formulated tenofovir gel applied rectally

 

Prevention Option(s)
Microbicides
Study Design
Controlled
Randomized
Double-blind
Arms and Assigned Interventions
Description
Topical gel applied rectally
Mode of Delivery
Gel
Products
1% tenofovir gel
ARMs
Experimental
Description
Placebo gel applied rectally
Mode of Delivery
Gel
Products
HEC gel
ARMs
Placebo Comparator
Description
All participants will undergo an open label tenofovir tablet single dose administration (i.e. Tenofovir Disoproxil Fumarate 300 mg, aka Viread®)
Mode of Delivery
Tablet
Products
TDF
Results
A phase 1 randomized, double blind, placebo controlled rectal safety and acceptability study of tenofovir 1% gel (MTN-007)
Official Code
NCT00984971
Trial Sponsors
CONRAD, NIAID, MTN
September 2009
July 2010
Enrollment
18
18
Years
Population
Women
Men
Sites

University of Pittsburgh CRS

Pittsburgh, Pennsylvania
United States of America

UCLA Center for HIV Prevention Research

Los Angeles
United States of America