JAC Advance Access published online on June 7, 2006
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkl238
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1 Department of Pharmacy and Pharmaceutical Science, University at Buffalo, Buffalo, NY, USA; Infectious Disease Unit, Department of Medicine, University of Rochester, Rochester, NY, USA
* To whom correspondence should be addressed. Objectives: The purpose of this study was to determine the pharmacokinetics and tolerability of three different indinavir and lopinavir/ritonavir dosing regimens. Methods: HIV-infected adults receiving lopinavir/ritonavir 400/100 mg twice daily with food had nine plasma samples taken over a 12 h dosing interval at baseline (BL), after adding indinavir 600 mg twice daily for 10 days (R1), indinavir 800 mg twice daily for 5 days (R2) and lopinavir/ritonavir 533/133 mg plus indinavir 600 mg twice daily for 10 days (R3). Plasma samples were assayed using HPLC. Results: A total of 12 patients completed the BL visit [10 male; mean (SD) age = 43.9 (5.8) years] and 9, 7 and 7 completed R1, R2 and R3 visits, respectively. Two subjects discontinued treatment due to hypertriglyceridaemia. Compared with BL, the R3 lopinavir AUC (P < 0.05) and Cmin (P = 0.0025) were significantly higher and the R2 AUC trended higher (P = 0.09). The indinavir AUC (P = 0.030) and Cmax (P = 0.035) were significantly higher for R2 compared with R1. There was a trend for increased total bilirubin (TB) after the addition of indinavir (P=0.09). Lopinavir and indinavir AUC, Cmax and Cmin were associated with TB during univariate analyses (P < 0.01) while only lopinavir AUC (P = 0.0004) and indinavir AUC (P = 0.0028) were associated with TB during multivariate analysis. Only indinavir AUC was significant when both drugs were included in the model (P = 0.0028). Conclusions: Elevated lopinavir and indinavir concentrations are associated with elevated TB.
Received January 6, 2006
Revised March 23, 2006
Accepted May 12, 2006
Original article
Association of total bilirubin with indinavir and lopinavir plasma concentrations in HIV-infected patients receiving three different double-boosted dosing regimens
Robert Dicenzo 1 *,
Amneris Luque 2,
Panupoong Larppanichpoonphol 2,
and
Richard Reichman 2
2 Infectious Disease Unit, Department of Medicine, University of Rochester, Rochester, NY, USA
Robert Dicenzo, E-mail: robert_dicenzo{at}urmc.rochester.edu
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