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MTN-011 was a Phase 1 study that evaluated the effect of coitus on the PK and PD of tenofovir 1% gel following pericoital or daily gel dosing. The study enrolled heterosexual, sexually active monogamous couples, in which both individuals were healthy and HIV-negative.  This Phase 1 expanded safety study assessed tenofovir PK in genital tract secretions (CVL), rectal (rectal sponge) and both intracellular and extracellular genital tissue compartments (vaginal and cervical biopsies) in the absence of, or following coitus. PD (i.e., antiviral activity) was also assessed in CVL samples. Group 1 examined PK/PD following a single dose of gel applied 1 hour prior, 24 hours prior, or 1 hour before and 1 hour after (BAT) sex. The single or BAT dosing regimens will provide PK/PD data in the absence of any tissue reservoir. Group 1 completed follow-up on June 9, 2014 and preliminary results were reported at the HIV Research for Prevention (HIV R4P) meeting in October 2014. It was determined on November 11, 2014 that Group 2 which aimed to examine PK/PD following seven daily doses of gel with the last dose applied 1 hour or 72 hours prior to sex would not proceed.

Protocol Chair(s)
Herold, Betsy (Protocol Chair)
Protocol Title
Phase 1 Evaluation of Coitus on the Pharmacokinetics and Pharmacodynamics of Tenofovir 1% Gel Following Pericoital or Daily Gel Dosing
DAIDS Protocol ID
11825
Status
Participants off Study and Primary Analysis Completed
Formulation
Gel
Drug
Tenofovir   
Study Focus/Product Administration
Vaginal
Study Type
Pharmacokinetics
Pharmacodynamic
Safety
Study Phase
Phase I  
Countries
United States
Population
Men (cisgender men, non‐transgender men)   
Women (cisgender women, non‐transgender women)
Funder(s)
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US National Institute of Mental Health
US National Institutes of Health
Sponsor(s)
CONRAD