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The Effect of Azithromycin on the Pharmacokinetics of Indinavir
Author(s) -
Foulds George,
LaBoyGoral Lucia,
Wei Greg C. G.,
Apseloff Glen
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 - 10.1177/00912709922008371
Subject(s) - azithromycin , indinavir , pharmacokinetics , pharmacology , medicine , chemistry , human immunodeficiency virus (hiv) , antibiotics , virology , antiretroviral therapy , viral load , biochemistry
This study was performed to examine the effect of the coadministration of azithromycin on the pharmacokinetics of the protease inhibitor indinavir (Crixivan®). In an open‐label, parallel‐design study, 32 healthy male and female volunteers were given indinavir (800 mg tid) for 5 days. One hour prior to the first dose of indinavir on day 5, 18 subjects received 1200 mg azithromycin (Zithromax®), and 14 subjects received matching placebo. Serial samples of plasma were obtained for 8 hours following the morning dose of indinavir on days 4 and 5 and assayed for indinavir by HPLC/UV. Twenty‐seven subjects completed the study. Following coadministration of azithromycin with indinavir, there was no significant change between day 5 and day 4 in AUC (20.7 mg•hr/ml and 23.1 mg•hr/ml; 90% CI on the ratio 81%‐100%) or C max (9.88 mg/ml and 10.3 mg/ml; 90% CI 86%‐108%). The day 5 to day 4 difference in indinavir concentrations following coadministration with azithromycin was not significantly different from the day 5 to day 4 difference with placebo (AUC p = 0.68; C max p = 0.074). Therefore, azithromycin does not significantly alter the kinetics of indinavir .