NCT01330199

Pharmacokinetics of Tenofovir, Emtricitabine, Maraviroc, and Raltegravir in Cervical, Vaginal, and Rectal Tissues and Secretions

A Phase I Investigation of Single-Dose Pharmacokinetics of Tenofovir, Emtricitabine, Maraviroc, and Raltegravir in Cervical, Vaginal, and Rectal Tissues and Secretions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to develop a predictive antiretroviral pharmacokinetic model of mucosal fluid and tissue distribution in genital tract fluid, rectal fluid and 3 mucosal tissues. This will be accomplished by determining the pharmacokinetic disposition and dose proportionality of four antiretrovirals (tenofovir, emtricitabine, maraviroc, and raltegravir) in human rectal and cervicovaginal fluid and rectal, cervical, and vaginal tissue.

Conditions

• Healthy Adult Females

Interventions

Type	Name	Description
OTHER	Pharmacokinetic Sampling	Blood plasma, Rectal, Cervical, and Vaginal Tissues and Secretions

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2011-04-06
• Last updated: 2013-09-17

Locations

1 site across 1 country: United States