A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS
NCT ID: NCT00002034
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Zidovudine
Ganciclovir
Eligibility Criteria
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Inclusion Criteria
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
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).
13 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Locations
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Univ of Alabama at Birmingham
Birmingham, Alabama, United States
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, United States
Miami Veterans Administration Med Ctr
Miami, Florida, United States
Dr Winkler Weinberg
Roswell, Georgia, United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, United States
Dr Alfred F Burnside Jr
Columbia, South Carolina, United States
Univ TX Galveston Med Branch
Galveston, Texas, United States
Southern Alberta HIV Clinic / Foothills Hosp
Calgary, Alberta, Canada
Countries
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Other Identifiers
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ICM 1692
Identifier Type: -
Identifier Source: secondary_id
029F
Identifier Type: -
Identifier Source: org_study_id