Cytomegalovirus Retinitis, HIV Infections
Conditions
Keywords
Retinitis, AIDS-Related Opportunistic Infections, Ganciclovir, Drug Interactions, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Zidovudine
Brief 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.
Interventions
DRUGZidovudine
DRUGGanciclovir
Sponsors
Hoffmann-La Roche
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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).
Countries
Canada, United States
Outcome results
None listed