A Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS Patients

Inclusion Criteria

Concurrent Medication:

Recommended:

• PCP prophylaxis.

Allowed:

• Antiretroviral therapy during induction and pharmacokinetic part of study, provided patient remains on the same antiretroviral therapy for the duration of the study.
• Chemotherapy for Kaposi's sarcoma, provided patient is hematologically stable for at least 30 days prior to study entry.
• Recombinant human erythropoietin.
• GM-CSF and G-CSF.
• Other medications necessary for patient's welfare, at the physician's discretion.

Patients must have:

• HIV infection.
• Biopsy-proven cytomegalovirus (CMV) colitis.
• Life expectancy of at least 3 months.
• No active AIDS-defining opportunistic infection requiring therapy that is known to cause nephrotoxicity or myelosuppression.

NOTE:

• Kaposi's sarcoma is permitted if patients are hematologically stable for at least 30 days prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Other etiologies for diarrhea identified at study entry.

PER AMENDMENT 3/14/95:

• For subjects who have diarrhea - no other etiologies for diarrhea identified within 6 weeks of enrollment.
• Known hypersensitivity to study drugs.
• CMV retinitis.

Concurrent Medication:

Excluded:

• Acyclovir or probenecid (PER AMENDMENT 3/14/95).
• Immunomodulators.
• Biologic response modifiers (other than GM-CSF or G-CSF).
• Investigational agents, with the exception of treatment IND drugs.
• Antacids.
• H2 blockers.
• Proton pump inhibitors.
• Foscarnet during induction and pharmacokinetic part of study.
• Intravenous CMV retinitis maintenance therapy (including ganciclovir) during pharmacokinetic part of study.
• Nephrotoxic agents.

Prior Medication:

Excluded within 14 days prior to study entry:

• Immunomodulators.
• Biologic response modifiers (other than GM-CSF or G-CSF).
• Investigational agents, with the exception of treatment IND drugs.