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.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety