Inclusion Criteria
Concurrent Medication:
Allowed:
- Topical acyclovir.
- Selected cytokines.
- Allowed after the first 4 weeks of ganciclovir:
- Zidovudine (AZT) at a reduced dose (500 mg/day) in patients who have tolerated ganciclovir without grade 3/4 hematological toxicity.
- Other anti-retrovirals after consultation with the Syntex study monitor.
Patients must have the following:
- AIDS and newly diagnosed Cytomegalovirus (CMV) retinitis.
- An understanding of the nature of the study, agreement to its provisions, and willingness to sign the informed consent approved by the appropriate institutions review board, and Syntex.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Have only peripheral CMV retinitis (defined as a lesion outside the major temporal vascular arcades, greater than 1500 microns from the optic disk, or greater than 3000 microns from the fovea).
- Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment.
- Ocular conditions requiring immediate surgical correction (eg:
- retinal tear or detachment).
- Demonstrated hypersensitivity to acyclovir or ganciclovir.
- Dementia, decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the patient to comply with the protocol.
Concurrent Medication:
Excluded:
- Antimetabolites.
- Alkylating agents.
- Nucleoside analogs (excluding selected anti-retroviral agents).
- Imipenem-cilastatin.
- Interferons.
- Selected cytokines.
- Acyclovir (except topical acyclovir).
Patients with the following are excluded:
- Have only peripheral CMV retinitis (defined as a lesion outside the major temporal vascular arcades, greater than 1500 microns from the optic disk or greater than 3000 microns from the fovea).
- Concomitant conditions or diseases described in Exclusion Co-Existing Conditions.
Prior Medication:
Excluded within 1 month of study entry:
- Previous treatment with anti-cytomegalovirus therapy (e.g., ganciclovir, foscarnet or CMV hyperimmune globulin).
Purpose
