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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Ganciclovir; Ganciclovir triphosphate; Zidovudine

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).