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Trimethoprim/Sulfamethoxazole Does Not Affect the Steady‐State Disposition of Indinavir
Author(s) -
Sturgill Marc G.,
Seibold James R.,
Boruchoff Susan E.,
Yeh Kuang C.,
Haddix Heidi,
Deutsch Paul
Publication year - 1999
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/00912709922011737
Subject(s) - indinavir , pharmacokinetics , crossover study , cmax , placebo , trimethoprim , sulfamethoxazole , pharmacology , chemistry , oral administration , drug interaction , medicine , antibiotics , human immunodeficiency virus (hiv) , sida , immunology , biochemistry , alternative medicine , pathology , viral disease
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 AUC 0‐12h and C max TMP values ( p = 0.031 and 0.030, respectively), and a 5% increase in geometric mean AUC 0‐12h 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 .