A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS

Launched by HOFFMANN-LA ROCHE · Aug 30, 2001

Keywords

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Gender

ALL

Eligibility criteria

• • 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).