Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients With AIDS Who Have CMV Retinitis
Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)
1 other identifier
interventional
300
1 country
12
Brief Summary
To compare cidofovir with a commonly used treatment regimen, ganciclovir given by mouth (oral) and through an eye device (intraocular) , in order to determine the safety and effectiveness of cidofovir in preventing vision loss in patients who have AIDS complicated by CMV (cytomegalovirus) retinitis. Cidofovir needs to be compared to ganciclovir to determine the best way to treat CMV retinitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
12 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
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedFebruary 23, 2011
June 1, 2003
November 2, 1999
February 22, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- You may be eligible for this study if you:
- Are 13 years of age or older (parent or guardian consent required if under 18).
- Agree to practice sexual abstinence or use effective birth control during and for 90 days after the study.
- Have AIDS.
- Have CMV retinitis.
You may not qualify if:
- You will not be eligible for this study if you:
- Have a history of heart or kidney disease.
- Have medical problems which would prevent you from completing the study.
- Are pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Univ of Miami / Bascom Palmer Eye Institute
Miami, Florida, 33136, United States
Emory Eye Clinic
Atlanta, Georgia, 30322, United States
Northwestern Univ / SOCA
Chicago, Illinois, 60611, United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
New York Hosp / Cornell Med Ctr
New York, New York, 10021, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Univ of Texas Galveston
Galveston, Texas, 775550435, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Primary Completion
June 1, 2000
Last Updated
February 23, 2011
Record last verified: 2003-06