Pharmacokinetics, Safety, and Tolerability of Maraviroc in HIV-Negative Subjects with Impaired Renal Function

AbstractPurpose: This open-label, nonrandomized, parallel-group study was conducted to explore the pharmacokinetics, safety, and tolerability of maraviroc in renally impaired subjects.Methods: Subjects with normal renal function; mild, moderate, or severe renal impairment; or end-stage renal disease (ESRD) (n = 6 per group) were enrolled. Subjects with normal function (period 1), severe impairment, and ESRD received a single 300 mg dose of maraviroc. Subjects with normal function (period 2), mild impairment, and moderate impairment received 150 mg for 7 days at adjusted intervals of twice daily, once daily, and every 48 hours, respectively, with saquinavir/ritonavir (SQV/r). Maraviroc was quantified in plasma, urine, and dialysate by tandem high-performance liquid chromatography–mass spectrometry.Results: With SQV/r, geometric mean steady-state maraviroc area under the plasma concentration-time curve for the dosing interval (AUCtau) was 5,341 (coefficient of variation [CV], 27%), 8,119 (35%), and 6,193 (2...