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At present, little is known about tenofovir levels in the rectal compartment following vaginal application or about tenofovir levels in the genital compartment following rectal application. This Phase 1, two arm, crossover, randomized trial in healthy, HIV-negative, sexually-active women aged 21 to 45 (inclusive) years assessed the level of tenofovir in both the rectal and vaginal compartments after the rectal and vaginal application of tenofovir RG 1% gel. Women were randomized to the sequence of vaginal or rectal tenofovir RG 1% gel application for two weeks. Blood, vaginal and rectal samples, including tissue, were collected to assess the PK endpoints at the end of the first period of product use.  Following a minimum 6-week washout period, women who initially applied the product vaginally were crossed-over to apply product rectally and vice versa. Secondary objectives of MTN-014 study included safety assessment of tenofovir RG 1% gel after 2 weeks of rectal and after 2 weeks of vaginal use.

The protocol was amended in May 2013 to incorporate directly observed dosing (DOD) to ensure complete compliance to the study product regimen, critical for this Phase 1 PK clinical trial. The study was completed in late 2014 with 14 women taking part in the study.

Protocol Chair(s)
Justman, Jessica (Protocol Co-Chair)
Nair, Gonasagrie (Lulu) (Protocol Chair)
Protocol Title
A Phase 1 Crossover Trial Evaluating the Pharmacokinetics of Tenofovir Reduced-Glycerin 1% Gel in the Rectal and Vaginal Compartments In Women
DAIDS Protocol ID
11885
Status
Participants off Study and Primary Analysis Completed
Formulation
Gel
Drug
Tenofovir   
Study Focus/Product Administration
Rectal
Vaginal
Study Type
Pharmacokinetics
Pharmacodynamic
Safety
Study Phase
Phase I  
Countries
United States
Population
Women (cisgender women, non‐transgender women)
Funder(s)
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health
Sponsor(s)
CONRAD