A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS
2 other identifiers
interventional
100
2 countries
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
January 1, 1992
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify 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 qualify 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.
- 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.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, 94609, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115, United States
Miami Veterans Administration Med Ctr
Miami, Florida, 33125, United States
Dr Winkler Weinberg
Roswell, Georgia, 30076, United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153, United States
Dr Alfred F Burnside Jr
Columbia, South Carolina, 29204, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550, United States
Southern Alberta HIV Clinic / Foothills Hosp
Calgary, Alberta, Canada