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

Launched by HOFFMANN-LA ROCHE · Aug 30, 2001

Keywords

ClinConnect Summary

Patients currently on either AZT or ddI receive ganciclovir therapy.

Gender

ALL

Eligibility criteria

• • 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).