A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

Inclusion Criteria

Concurrent Medication:

Allowed:

• Topical and ophthalmic nucleoside analogues.

Patients must have:

• HIV positive.
• No more than two episodes of CMV retinitis progression (relapse resulting in reinduction with intravenous anti-CMV therapy) since the original retinitis diagnosis.
• Currently stable retinitis.

Prior Medication:

Allowed:

• Foscarnet prior to the 4 weeks of intravenous induction therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Persistent or clinically significant diarrhea, nausea, or abdominal pain.
• Severe odynophagia.
• Other gastrointestinal (GI) symptoms or uncontrolled GI disease.
• Active CMV disease of the GI tract (e.g., CMV colitis, CMV esophagitis).
• Ocular media opacities (corneal, lenticular, or vitreal) that prevent ophthalmologic retinal assessments.
• Dementia, decreased mentation, or other encephalopathic signs and symptoms that would preclude informed consent or study compliance.

Concurrent Medication:

Excluded:

• Acyclovir sodium (Zovirax) by any route other than topical.
• Valacyclovir.
• Brovavir.
• Vidarabine.
• Amantadine hydrochloride.
• Cytarabine.
• Idoxuridine.
• Ribavirin.
• Interferon.
• Foscarnet (non-nucleoside pyrophosphate analogue).
• CMV hyperimmune globulin.
• Soluble CD4.
• Trichosanthin (Compound Q).
• Imipenem-cilastatin.
• Isoprinosine.
• Levamisole.
• Other investigational drugs.

Patients with the following prior condition are excluded:

History of hypersensitivity to acyclovir or ganciclovir.

Prior Medication:

Excluded:

• More than three induction regimens with intravenous anti-CMV therapy.
• Any prior oral ganciclovir.