A Randomized, Comparative, Placebo-Controlled Trial of the Safety and Efficacy of Oral Ganciclovir for Prophylaxis of Cytomegalovirus (CMV) Retinal and Gastrointestinal Mucosal Disease in HIV-Infected Individuals With Severe Immunosuppression

Inclusion Criteria Concurrent Medication: Allowed: Antiretroviral therapy. Anti-PCP prophylaxis. Maintenance or prophylaxis therapy for other opportunistic infections besides CMV. Patients must have: Working diagnosis of HIV infection. CD4 count <= 100 cells/mm3. Positive CMV serology (IgG) or CMV culture, in the absence of active disease, documented at any time prior to study entry. Reasonably good health. Life expectancy of at least 6 months. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Acute life-threatening illness. Active lymphoma. Hypersensitivity to acyclovir. Lack of willingness or ability, in the opinion of the clinician, to comply with protocol requirements. Concurrent Medication: Excluded: Vidarabine. Amantadine hydrochloride (Symmetrel). CMV hyperimmune globulin/intravenous immune globulin. Cytarabine. Fiacitabine (FIAC) or fialuridine (FIAU). Foscarnet. Intravenous ganciclovir. HPMPC. Idoxuridine. Intravenous acyclovir. Oral acyclovir at > 1 g/day. Other drugs with potential anti-CMV activity. Prior Medication: Excluded within 60 days prior to study entry: Foscarnet. Excluded within 2 weeks prior to study entry: Vidarabine. Amantadine hydrochloride (Symmetrel). CMV hyperimmune globulin/intravenous immune globulin. Cytarabine. Fiacitabine (FIAC) or fialuridine (FIAU). Ganciclovir. HPMPC. Idoxuridine. Intravenous acyclovir. Oral acyclovir at > 1 g/day. Other drugs with potential anti-CMV activity.