NCT00961272

Evaluating the Pharmacokinetics of 400 mg Oral Dose of Raltegravir in HIV-Infected Pre-Menopausal Women

An Open-Label, Pilot Study to Characterize the Pharmacokinetics of a 400mg Oral Dose of Raltegravir in the Cervicovaginal Fluids of HIV-Infected Pre-menopausal Women

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: Kristine Patterson, MD · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to characterize the pharmacokinetics of raltegravir in cervicovaginal fluids as compared to blood plasma of HIV-infected pre-menopausal women.

Detailed description

Participants: Six HIV-positive pre-menopausal women already undergoing therapy with raltegravir. Procedures (methods): This study will be conducted at a single site: the University of North Carolina at Chapel Hill. An outpatient screening visit will assess subject suitability and willingness to participate. During one pharmacokinetic visit women will be asked to self-collect cervicovaginal samples using a cervicovaginal fluid aspirator at the following time points: pre-dose and 1, 2, 4, 6, 8, 10, and 12 hours after raltegravir 400mg dose administration. One 3mL EDTA tube will be collected at the same time points to analyze blood plasma. A follow-up safety visit will be completed within 30 days of the inpatient stay.

Conditions

• HIV Infections

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2009-08-18
• Last updated: 2014-02-28

Locations

1 site across 1 country: United States