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

Inclusion Criteria Patients must have the following: Confirmation of HIV infection by HIV-antibody testing, p24 antigen assay, or culture of HIV, or have diagnosis of AIDS by CDC criteria. CMV retinitis diagnosed within one month of study entry. Understand the nature of the study, agree to its provisions, and sign the informed consent approved by the appropriate institutional review board and Syntex. 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.