A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine

Inclusion Criteria Concurrent Medication: Required: Concomitant AZT or ddI. Allowed: Probenecid. Aerosolized pentamidine. Patients must have: Asymptomatic HIV infection. CMV seropositivity or CMV culture positivity at present or at any time in the past. No history of CMV disease (e.g., retinitis, colitis) or any other AIDS-defining illness. Treatment with AZT or ddI for at least 1 month prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Uncontrolled diarrhea (three or more loose stools/day). Clinically significant gastrointestinal symptoms including persistent nausea or abdominal pain. AZT patients only: Deficiency in glucose-6-phosphate dehydrogenase. ddI patients only: Grade 2 or worse peripheral neuropathy. Concurrent Medication: Excluded: Combination antiretroviral therapy. G-CSF or GM-CSF. Acyclovir. Amphotericin B. Amikacin. Captopril. Carbamazepine. Cimetidine. Cyclosporine. Glutethimide. Gentamicin. Griseofulvin. Ibuprofen. Imipenem-Cilastatin. Lithium. Methicillin. Methotrexate. Naproxen. Pentamidine (Pentam 300) (Aerosolized drug permitted). Phenacetin. Phenobarbital. Phenytoin. Piroxicam. Ribavirin. Rifampin. Tobramycin. Vidarabine. Zalcitabine. Other investigational drugs. Patients with the following prior conditions are excluded: History of hypersensitivity to acyclovir or ganciclovir. AZT patients only: History of gout, uric acid, kidney stones, peptic ulcer or porphyria. ddI patients only: History of pancreatitis or alcoholism, or seizures within 6 months prior to study entry or prior need for anticonvulsant therapy. Prior Medication: Excluded: Combination antiretroviral therapy within 1 month prior to study entry. Required: AZT at 500 mg/day for at least 1 month prior to study entry (with 100 mg administered five times per day for at least 1 week prior to study entry). OR ddI at recommended dose for at least 1 month prior to study entry (with 250 mg administered every 12 hours for at least 1 week prior to study entry). History of alcoholism (in ddI patients).