A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease

Inclusion Criteria

Concurrent Medication:

PER AMENDMENT 10/24/95: Allowed:

• All antiretroviral agents and other medications except those listed under Exclusion - Concurrent Medications.
• Didanosine. However, patients receiving both drugs (didanosine and ganciclovir) should be monitored for toxicity.
• Amphotericin B is allowed but requires additional monitoring.

Patients must have:

• HIV infection.
• CMV infection.
• CD4 count < 150 cells/mm3 or < 15 percent AND/OR quiescent CMV disease.
• NO loss of sight from CMV retinitis.
• NO acute opportunistic infection.
• Life expectancy at least to study completion.
• Consent of parent or guardian.

NOTE:

• Infants < 6 months of age at enrollment must have been >= 36 weeks gestational age at birth.

NOTE:

• Patients may co-enroll in other ACTG protocols that do not involve the administration of disallowed medications.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Loss of sight in one eye for any reason, with evidence of CMV retinitis in the other eye.
• Acute or chronic diarrhea that would affect absorption.
• Clinical or laboratory toxicities of grade 3 or worse.

Concurrent Medication:

Excluded:

• Foscarnet.
• Acyclovir.
• Interferon.
• Myelotoxic agents for malignancy or other condition.
• Other agents with anti-CMV activity. (NOTE:

Enrollment of patients on IVIG must be discussed with protocol chair.)

• Imipenem/cilastatin sodium.

Prior Medication:

Excluded within 30 days prior to study entry:

• G-CSF or GM-CSF.