Back to top

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.

Protocol Chair(s)
Hendrix, Craig (Protocol Chair)
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
Formulation
Gel
Oral Tablet
Drug
Tenofovir   
Viread®  (tenofovir disoproxil fumarate)
Study Focus/Product Administration
Oral
Vaginal
Study Type
Behavioral
Pharmacokinetics
Safety
Study Phase
Phase II
Countries
South Africa
Uganda
United States
Population
Pregnant  
Women (cisgender women, non‐transgender women)
Funder(s)
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US National Institutes of Health
Sponsor(s)
CONRAD, Gilead Sciences, Inc.