Evaluating the Pharmacokinetics of 400 mg Oral Dose of Raltegravir in HIV-Infected Pre-Menopausal Women
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||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|
- To describe the pharmacokinetics of raltegravir in cervicovaginal secretions as compared to blood plasma at steady-state in six HIV-positive women. [ Time Frame: one year ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
|HIV-infected, pre-menopausal women|
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.
|United States, North Carolina|
|The University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7215|
|Principal Investigator:||Kristine Patterson, MD||University of North Carolina, Chapel Hill|
|Principal Investigator:||Angela Kashuba, PharmD||University of North Carolina, Chapel Hill|