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

Roche

Status: Completed

Conditions: Cytomegalovirus Retinitis; HIV Infections

Treatments: Drug: Ganciclovir; Drug: Zidovudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002034

ICM 1692

029F

Details and patient eligibility

About

To evaluate the safety and tolerance of long-term ganciclovir (DHPG) therapy for newly diagnosed macular threatening Cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate the clinical response to a 52 week course of intravenous DHPG therapy. To evaluate the safety and tolerance of long-term DHPG with concurrent treatment with zidovudine (AZT). (Patients utilizing treatment with other anti-retroviral drugs will be considered for study entry on a case by case basis.) To determine survival in this group of patients with AIDS and CMV retinitis.

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).