A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment With Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People With AIDS
2 other identifiers
interventional
150
2 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
13 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
July 1, 1992
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
East Bay AIDS Ctr
Berkeley, California, 94704, United States
Davies Med Ctr / c/o HIV Institute
San Francisco, California, 94114, United States
Dr David Busch
San Francisco, California, 94118, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
Med Service
Miami, Florida, 33125, United States
Miami Veterans Administration Med Ctr
Miami, Florida, 33125, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215, United States
New York Univ Med Ctr
New York, New York, 10016, United States
Cornell Univ Med College
New York, New York, 10021, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550, United States
Saint Paul's Hosp
Vancouver, British Columbia, Canada