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. The two primary manuscripts were published in PLoS One in January 2013 and AIDS and Behavior in February 2013 respectively.
US National Institutes of Health