A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment With Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People With AIDS

Exclusion Criteria

• •Concurrent Medication:
• •The following are excluded:
• •Antimetabolites. Alkylating agents. Selected nucleoside analogs. Selected Cytokines.
• •Patients with the following are excluded:
• •Persistent diarrhea, nausea, or abdominal pain or other clinically significant GI symptoms or uncontrolled gastrointestinal disease. Diarrhea is defined as 3 or more unformed stools per day.
• •Have ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment and photography.
• •Have ocular conditions requiring immediate surgical correction (e.g. retinal tear or detachment).
• •Require continuation of concomitant medications precluded by this protocol, e.g., antimetabolites, alkylating agents, selected nucleoside analogs, and selected cytokines and other medications listed in the protocol.
• •History of hypersensitivity to acyclovir or ganciclovir.
• •Dementia, decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the subject to give informed consent or comply with the protocol.
• •Prior Medication:
• •The following are excluded:
• •\- Previous use of anti-cytomegalovirus drug (e.g., ganciclovir, foscarnet, FIAC, or CMV hyperimmune globulin) within one month of study entry.