A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis

Inclusion Criteria

Concurrent Medication:

Allowed:

• Topical drugs and ophthalmics.

Patients must have:

• AIDS.
• Unilateral CMV retinitis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Chronic, clinically significant diarrhea, nausea, abdominal pain,or other symptoms of uncontrolled gastrointestinal disease.
• Ocular opacities (corneal, aqueous, lens, or vitreous) preventing ophthalmologic retinal assessment of fundus photography.
• Acute retinal necrosis or any other intraocular condition that might preclude study completion.
• Ocular condition requiring immediate surgery.
• Unable to have long-term IV catheter placement.

Concurrent Medication:

Excluded:

• Vidarabine.
• Amantadine hydrochloride.
• Cytarabine.
• FIAC or FIAU.
• Idoxuridine.
• Ribavirin.
• Valacyclovir.
• Foscarnet.
• CMV hyperimmune globulin.
• Soluble CD4.
• Trichosanthin.
• Imipenem-cilastatin.
• Isoprinosine.
• Levamisole.
• Interferon.
• Other investigational drugs.

Patients with the following prior conditions are excluded:

• History of previous invasive intraocular surgery of any kind in the involved eye or any condition for which ocular surgery is contraindicated.
• History of hypersensitivity to acyclovir or ganciclovir.

Prior Medication:

Excluded:

• Any prior oral ganciclovir in a CMV retinitis treatment protocol OR more than 4 months of prior oral ganciclovir in a prophylaxis study (per amendment).
• Prior intravitreal ganciclovir implant.
• More than two prior induction dose courses of IV anti-CMV therapy (per amendment).
• Intravitreal injection of any antiviral medication within the past 4 weeks (per amendment).