CLINICAL TRIAL: MARAVIROC EXPOSURE IN BLOOD, CERVICOVAGINAL FLUID, VAGINAL TISSU

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Purpose: The purpose of the study is to measure maraviroc concentrations in blood, cervicovaginal fluid (CVF), as well as explore CCR5 receptor occupancy in blood and cervical mononuclear cells and vaginal tissue, at both a single dose and steady state dosing of maraviroc. Participants: Healthy female volunteers aged 18 to 49 years, inclusive; with an intact uterus and cervix, with no medical conditions, and no concomitant medications (oral contraceptives allowed). Procedures (methods): Two intense pharmacokinetic visits will be conducted, one around the first dose of maraviroc and the second after steady state has been reached. Morning trough samples will be checked daily during dosing to steady state. Sampling will include matched blood and CVF samples for drug concentrations, collection of peripheral blood mononuclear cells (PBMC) and cervical mononuclear cells (CV-MNC) at baseline and at steady state concentrations of maraviroc. At steady state, a vaginal biopsy will be taken to assess tissue concentrations and receptor occupancy. A clinically relevant dose of maraviroc 300mg BID will be used; subjects will receive a total of 13 dose. Pharmacokinetics parameters will be compared between blood and CVF, and receptor occupany among PBMC, CV-MNC, and vaginal tissue will be assessed.