J Clin Pharmacol
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Steady-State Relative Bioavailability of Three Oral Ganciclovir Dosage Regimens Delivering 6,000 mg/day in Patients with Human Immunodeficiency Virus

Donald Jung, PhD

Kay Griffy, PharmD

Rodney Wong, PhD

Roche Global Development, Palo Alto, California

Wayne Colburn, PhD, FCP

Harris Laboratories, Inc., Phoenix, Arizona

Jim Hulse, PhD

Lincoln, Nebraska

This study was designed to determine the steady-state relative bioavailability of ganciclovir after three dosage regimens designed to deliver 6,000 mg/day. The study design was an open-label, randomized, three-treatment crossover design in which 22 human immunodeficiency virus (HIV) and cytomegalovirus (CMV) seropositive ptients received in random order multiple oral doses of ganciclovir 1,000 mg six times a day, 1,500 mg four times a day, and 2,000 mg three times a day. Blood samples were obtained on day 3 of each oral regimen over a 24-hour time interval. Mean steady-state average serum concentrations of ganciclovir were greater than 1.0 1tg/mL, which exceeds the median in vitro inhibitory concentration (1%)) of most CMV isolates (0.5-1.0 FLg/mL). All three regimens resulted in values for area under the concentration-time curve from 0 to 24 hours (AUCO 24) that were comparable to those seen after maintenance ganciclovir intravenous infusions of 5 mg/kg/day. The 1,000 mg six times daily regimen resulted in an AUCO,24 that was significantly higher than that of the 1,500 mgfour times daily or the 2,000 mg three times daily regimens, although the differences were less than 12.5%.


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