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

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).