Safety and pharmacokinetics of nelfinavir coadministered with zidovudine and lamivudine in infants during the first 6 weeks of life.

摘要: The safety and pharmacokinetics of nelfinavir coadministered with zidovudine lamivudine were studied in 26 infants during the first 6 weeks life. Cohort 1 (n = 7) received 10 mg/kg 3 times a day, cohort 2 19) 40 twice day. Two at week none exceeded target 24-hour area under curve (AUC) 30 mug.h/mL, equal to 10th percentile AUC for adults receiving standard dosing. In 2, median was 38 mug.h/mL both time points, considerable variability among infants. Three 11 4 did not meet target. Median oral clearance 2.1 L/h/kg 6. ratio plasma concentrations metabolite M8 unchanged increased from 0.16 (range: 0-0.38) 0.56 0.4-1.47) (P < 0.01). There no significant differences any other pharmacokinetic parameters when results compared. Few adverse events attributed nelfinavir. These data suggest that is well tolerated these doses, but exposure frequently less than seen taking Further investigations larger such as 75 should be undertaken.