Microbicide Trials Network

MTN-001

Details

Protocol Title: 
Phase 2 Adherence and Pharmacokinetics Study of Oral and Vaginal Preparations of Tenofovir
DAIDS Protocol ID: 
10617
Status: 
Participants off Study and Primary Analysis Completed

Protocol Chair(s)

Craig Hendrix (Protocol Chair)

Description

MTN-001 is a Phase II trial directly comparing the oral tablet and vaginal gel formulations of the antiretroviral (ARV) drug tenofovir. Specifically, MTN-001 is evaluating women’s adherence to and acceptance of three daily regimens – tenofovir gel, tenofovir tablet and the two taken together – and the pharmacokinetics of each approach. Pharmacokinetic studies are conducted to learn how a particular drug is absorbed by and distributed in the body over time. Researchers will enroll 144 sexually active HIV-negative women at sites in Uganda, South Africa and the United States, who at the end of the 21-week study will have followed each regimen for six weeks, with one week between when no study product is used. The 72 women enrolled at the two U.S. sites will be involved in more intensive assessments of each approach.

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 2, multi-site, randomized, six sequence, three period, open label crossover study