Cytomegalovirus Retinitis, HIV Infections
Conditions
Keywords
Retinitis, Ganciclovir, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome
Brief summary
To compare the time to progression of CMV retinitis between oral ganciclovir and IV ganciclovir during 20 weeks of maintenance treatment. To compare the safety and tolerance of oral ganciclovir with IV ganciclovir therapy during 20 weeks of maintenance treatment. To describe the safety and tolerance of oral ganciclovir treatment when given concurrently with anti-retroviral treatment, e.g. zidovudine or ddI. To describe the survival of people with AIDS and CMV retinitis.
Detailed description
Approximately 150 subjects with AIDS and newly diagnosed CMV retinitis will be enrolled in the study to achieve 120 randomized subjects. Eligible subjects will have CMV retinitis which has been diagnosed within one month of study entry by an ophthalmologist using indirect ophthalmoscopy. Subjects will be accrued by recruitment or referral. Anyone who volunteers for the study, meets the eligibility criteria, and signs an informed consent will be eligible for entry.
Interventions
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
Patients must have the following: * Confirmation of HIV infection by HIV-antibody testing, p24 antigen assay, or culture of HIV, or have diagnosis of AIDS by CDC criteria. * CMV retinitis diagnosed within one month of study entry. * Understand the nature of the study, agree to its provisions, and sign the informed consent approved by the appropriate institutional review board and Syntex.
Exclusion criteria
Concurrent Medication: The following are excluded: * Antimetabolites. Alkylating agents. Selected nucleoside analogs. Selected Cytokines. Patients with the following are excluded: * Persistent diarrhea, nausea, or abdominal pain or other clinically significant GI symptoms or uncontrolled gastrointestinal disease. Diarrhea is defined as 3 or more unformed stools per day. * Have ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment and photography. * Have ocular conditions requiring immediate surgical correction (e.g. retinal tear or detachment). * Require continuation of concomitant medications precluded by this protocol, e.g., antimetabolites, alkylating agents, selected nucleoside analogs, and selected cytokines and other medications listed in the protocol. * History of hypersensitivity to acyclovir or ganciclovir. * Dementia, decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the subject to give informed consent or comply with the protocol. Prior Medication: The following are excluded: \- Previous use of anti-cytomegalovirus drug (e.g., ganciclovir, foscarnet, FIAC, or CMV hyperimmune globulin) within one month of study entry.
Countries
Canada, United States
Outcome results
None listed