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. The primary manuscript was published in Clinical Infectious Diseases on February 1, 2016.
US National Institute of Mental Health
US National Institutes of Health