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The Pharmacokinetics and Safety Profile of Oral Ganciclovir Combined with Zalcitabine or Stavudine in Asymptomatic HIV‐ and CMV‐Seropositive Patients
Author(s) -
Jung Donald,
AbdelHameed Magdy H.,
Teitelbaum Philip,
Dorr Albert,
Griffy Kay
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 - 10.1177/009127009903900511
Subject(s) - zalcitabine , ganciclovir , stavudine , pharmacokinetics , pharmacology , medicine , lamivudine , crossover study , didanosine , human cytomegalovirus , virology , virus , placebo , hepatitis b virus , alternative medicine , pathology
Two open‐label, randomized, multiple‐dose, three‐way crossover studies were performed to assess the pharmacokinetics and safety of oral ganciclovir 1000 mg q8h in asymptomatic patients seropositive for human immunodeficiency virus and cytomegalovirus. Ganciclovir was administered alone and in combination with zalcitabine 0.75 mg q8h (study 1) or stavudine 40 mg q12h (study 2). In the presence of zalcitabine, the only statistically significant change in the pharmacokinetic parameters of ganciclovir was a 22.2% mean increase in AUC 0–8 . However, there was no significant change in the renal clearance of ganciclovir when coadministered with zalcitabine, suggesting that the increase in serum ganciclovir concentration cannot be attributed to competition for active renal tubular secretion. No change in zalcitabine pharmacokinetics was observed in combination with ganciclovir. There were no significant changes in the pharmacokinetics of ganciclovir or stavudine when coadministered. Ganciclovir was well tolerated when given alone and in combination with either zalcitabine or stavudine.