BACKGROUND:

 

This study describes first dose and steady state pharmacokinetics of raltegravir (RAL) in cervicovaginal fluid (CVF) and blood plasma (BP).

 

METHODS:

 

Three cohorts of women were enrolled sequentially in a single-site, open-label pharmacokinetic study of oral raltegravir 400 mg twice daily: HIV-negative premenopausal, HIV-infected premenopausal, and HIV-infected postmenopausal women. BP and CVF were collected over 12 hours after a single observed dose and at steady state. RAL concentrations were measured by HPLC-MS methods. Data are expressed as median (interquartile range [IQR]). The ANOVA rank sum test was used to evaluate between-group differences in steady state raltegravir exposure (AUC0-12h).

 

(후략)