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 was a Phase 2, multi-site, randomized, six-sequence, three-period, open-label crossover study of adherence to, and PK of tenofovir disoproxil fumarate (TDF) 300 mg tablet and tenofovir 1% gel.  The study population included generally 18 to 45 year old healthy women who were HIV-uninfected, non-pregnant, sexually active, who used adequate contraception.  All participants enrolled at the US study sites underwent more intensive specimen collection for PK analysis.  In addition to the primary objectives above, the MTN-001 study characterized the differential safety profiles of the three different daily regimens of tenofovir, and assessed the level of study product sharing with non-participants.  This protocol also investigated factors associated with product adherence and potential variations in sexual activity and male condom use associated with the different regimens. An optional procedure for participants at one site - the BLHC CRS in New York - was the collection of rectal swabs to assess tenofovir levels in the rectum following intravaginal administration of tenofovir 1% gel. MTN-001 results were first presented at the 18th Conference on Retroviruses and Opportunistic Infections (CROI), February 27-March 3, 2011 in Boston, MA.

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