Published on Microbicide Trials Network (http://www.mtnstopshiv.org)

Home > RMP-02/MTN-006

RMP-02/MTN-006

Details
Protocol Title: 
Phase 1 rectal microbicide safety and acceptability trial of topically applied tenofovir compared with oral tablet
DAIDS Protocol ID: 
10769
Status: 
Participants off Study and Primary Analysis Completed

Protocol Chair(s)

Peter Anton [1] (Protocol Chair)
Sites
Pitt CRS [2]
UCLA CRS [3]
Countries
United States [4]
Description
Phase 1 rectal microbicide safety trial of topically applied tenofovir

RMP-02/MTN-006 will evaluate the safety and early pharmacokinetic profile of 1% vaginally-formulated tenofovir gel, applied rectally, during a single exposure followed by once-daily dosing for 7 days. This will be compared to a single oral dose. This study is designed as a Phase 1 rectal safety trial to support the vaginal microbicide application, should vaginal efficacy be demonstrated. Independently, this agent is being assessed for its safety as a rectal microbicide for use by men and women.
 

Other Study Info

Sponsors:

Division of AIDS, US National Institute of Allergy and Infectious Diseases

US National Institutes of Health

Co-Sponsors:

CONRAD, Gilead Sciences, Inc..

Study design:

Phase 1, randomized, two-site, partially-blinded, placebo controlled study
 

Printer-friendly version [5]
Source URL: http://www.mtnstopshiv.org/studies/911

Links:
[1] http://www.mtnstopshiv.org/users/panton
[2] http://www.mtnstopshiv.org/sites/51
[3] http://www.mtnstopshiv.org/sites/913
[4] http://www.mtnstopshiv.org/countries/united-states
[5] http://www.mtnstopshiv.org/print/911

Media Contacts:

Lisa Rossi -- Office: +1 412 641-8940 -- Mobile: +1 412 916-3315 -- Email: rossil@upmc.edu

Clare Collins -- Office: +1 412 641-7299 -- Mobile: +1 412 770-8643 -- Email: collcx@upmc.edu