Effect of fluconazole on indinavir pharmacokinetics in human immunodeficiency virus-infected patients.

Antimicrobial Agents and Chemotherapy
S De WitN Clumeck

Abstract

To evaluate a potential pharmacokinetic interaction of coadministration of fluconazole, and indinavir, a human immunodeficiency virus (HIV) protease inhibitor, 13 patients were enrolled in a multiple-dose, three-period, placebo-controlled, crossover study. Patients were randomly assigned to receive indinavir at 1,000 mg every 8 h for 7 1/3 days (with fluconazole placebo), fluconazole at 400 mg once daily for 8 days (with indinavir placebo), and indinavir with fluconazole in combination. The pharmacokinetics of both drugs were measured on day 8 of each treatment period. The peak concentration in plasma (Cmax) and the time to reach Cmax were obtained by inspection, and the area under curve (AUC) was calculated for indinavir and fluconazole for each treatment period in which the respective drugs were administered. There was a marginally (P = 0.08) statistically significant decrease in the AUC from 0 to 8 h (AUC(0-8)) for indinavir when it was administered with fluconazole. However, the magnitudes of the decreases in Cmax and the concentration at 8 h postdosing (C8) were not as great as the decrease in AUC(0-8). Although the 90% confidence interval for the geometric mean ratio was within the hypothesized limits, the clinical signif...Continue Reading

Citations

Nov 19, 2008·Antimicrobial Agents and Chemotherapy·Charles J L la PorteD William Cameron
Feb 16, 1999·Antimicrobial Agents and Chemotherapy·S E Bellibas
Oct 12, 1999·Journal of Clinical Pharmacology·M G SturgillP Deutsch
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