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

Home > MTN-007

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: 
Closed to Follow Up

Protocol Chair(s)

Kenneth Mayer [1] (Protocol Co-Chair)
Ian McGowan [2] (Protocol Chair)

Email Groups

MTN-007 Laboratory [3]
MTN-007 Management Team [4]
MTN-007 Pharmacists [5]
MTN-007 Protocol Safety Review Team [6]
MTN-007 Protocol team [7]
MTN-007 Publications Committee [8]
MTN-007 Safety MD [9]
MTN-007 Web Troubleshoot [10]
Sites
Pitt CRS [11]
The Fenway Institute CRS [12]
University of Alabama at Birmingham [13]
Countries
United States [14]
Description
Tenofovir Rectal Safety Study

MTN-007 is a Phase I, randomized, blinded, placebo-controlled safety and acceptability study of tenofovir 1% gel when applied rectally. Participants will be randomized to receive a single dose of tenofovir 1% gel, 2% N-9 gel or a placebo gel that is applied by a clinician at the study site. Participants will return to the clinic one week later, where they will be given a 7-day supply of the study gel. The study will enroll approximately 63 men and women at domestic sites.

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

Printer-friendly version [15]
Source URL: http://www.mtnstopshiv.org/studies/912

Links:
[1] http://www.mtnstopshiv.org/users/kmayer
[2] http://www.mtnstopshiv.org/users/imcgowan
[3] http://www.mtnstopshiv.org/people/emailgroups/106
[4] http://www.mtnstopshiv.org/people/emailgroups/112
[5] http://www.mtnstopshiv.org/people/emailgroups/111
[6] http://www.mtnstopshiv.org/people/emailgroups/107
[7] http://www.mtnstopshiv.org/people/emailgroups/104
[8] http://www.mtnstopshiv.org/people/emailgroups/207
[9] http://www.mtnstopshiv.org/people/emailgroups/157
[10] http://www.mtnstopshiv.org/people/emailgroups/116
[11] http://www.mtnstopshiv.org/sites/51
[12] http://www.mtnstopshiv.org/sites/914
[13] http://www.mtnstopshiv.org/sites/53
[14] http://www.mtnstopshiv.org/countries/united-states
[15] http://www.mtnstopshiv.org/print/912

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