A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
13–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
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.
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).
Clareo Health | A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS
