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Trimethoprim/sulfamethoxazole does not affect the steady-state disposition of indinavir.

Author(s): Sturgill MG, Seibold JR, Boruchoff SE, Yeh KC, Haddix H, Deutsch P

Affiliation(s): College of Pharmacy, Rutgers, State University of New Jersey, Piscataway 08854-8020, USA.

Publication date & source: 1999-10, J Clin Pharmacol., 39(10):1077-84.

Publication type: Clinical Trial; Randomized Controlled Trial

This study evaluates the safety and potential pharmacokinetic interaction between indinavir and trimethoprim/sulfamethoxazole (TMP/SMZ). In a randomized, three-period crossover fashion, 12 healthy adults received 1 week of indinavir sulfate 400 mg orally every 6 hours with placebo, TMP 160 mg/SMZ 800 mg orally every 12 hours with placebo, and indinavir sulfate with TMP/SMZ. Plasma indinavir, SMZ, and TMP concentrations were determined after the last dose of each treatment period. Concomitant administration resulted in a 17% decrease in geometric mean trough plasma indinavir concentrations (p = 0.032), an 18% increase in geometric mean AUC0-12 h and Cmax TMP values (p = 0.031 and 0.030, respectively), and a 5% increase in geometric mean AUC0-12 h SMZ values (p = 0.039). None of these effects was considered clinically significant. The combination of indinavir sulfate and TMP/SMZ is generally well tolerated, with no clinically significant pharmacokinetic interaction being noted.

Page last updated: 2006-01-31

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