A Phase I Study of a Fixed-Schedule Regimen of Alternating Oral and Intravenous Ganciclovir for Treatment of Cytomegalovirus Retinitis

Inclusion Criteria

Concurrent Medication:

Allowed:

• Erythropoietin, G-CSF, or GM-CSF.
• Antiretrovirals.

Patients must have:

• HIV infection.
• Evaluable CMV retinitis with photographable lesions.
• Life expectancy of at least 6 months.
• No active AIDS-defining opportunistic infections or malignancies that require nephrotoxic or myelosuppressive therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Evidence of retinal vascular or related infectious disease or other retinal lesions that would interfere with the ability to detect responses to therapy or progression.
• Corneal, lens, or vitreous opacification precluding funduscopic exam.
• Clinically significant pulmonary or neurologic impairment other than seizure disorder or CNS mass lesion.
• Inability to obtain temporary IV access.
• Requirement for permanent catheters for IV ganciclovir administration.
• Uncontrolled diarrhea or nausea preventing ingestion of medicine.
• Known hypersensitivity to IV or oral ganciclovir.

Concurrent Medication:

Excluded:

• Immunomodulators.
• Biologic response modifiers.
• Interferon.
• Related investigational agents.
• CMV prophylaxis.
• Systemic acyclovir.
• Any nephrotoxic agent.
• Any concomitant therapy that would prohibit use of ganciclovir.

Prior Medication:

Excluded:

• Prior treatment for CMV retinitis.
• More than 4 months of prior ganciclovir or foscarnet, or within 4 weeks prior to study entry.

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