CMV Retinitis Retreatment Trial
1 other identifier
interventional
300
1 country
9
Brief Summary
To assess the safety and efficacy of three therapeutic regimens (foscarnet, ganciclovir, or the combination) for recurrent or persistent AIDS-related cytomegalovirus (CMV) retinitis. Although therapy with foscarnet or ganciclovir halts retinitis progression in 90 percent of patients treated, relapses are common and may accelerate due to development of drug resistance, deteriorating immune function, or other factors. Treatment strategies currently being investigated include switching patients from one drug to the other or combining the two drugs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
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
Primary Completion
Last participant's last visit for primary outcome
September 1, 1995
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedMarch 1, 2011
February 1, 2011
November 2, 1999
February 28, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Required:
- At least 28 days of prior foscarnet or ganciclovir.
- Concurrent Medication:
- Allowed:
- G-CSF.
- Recommended:
- Antiretroviral therapy.
- Patients must have:
- HIV infection or AIDS.
- Active CMV retinitis after 28 or more days of either foscarnet or ganciclovir therapy.
- At least one lesion with one-quarter disk area or more that can be photographed.
- Visual acuity of 3 or more letters on ETDRS chart (5/200 Snellen) in an affected eye.
You may not qualify if:
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- Media opacity severe enough to preclude visualization of both fundi.
- Retinal detachment not scheduled for surgical repair.
- Patients with the following prior conditions are excluded:
- History of intolerance to ganciclovir or foscarnet sufficient to contraindicate use.
- History of combination foscarnet/ganciclovir therapy.
- Active drug or alcohol abuse sufficient to prevent compliance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
UCSD - Shiley Eye Ctr / SOCA
La Jolla, California, 920930946, United States
UCLA - Jules Stein Eye Institute / SOCA
Los Angeles, California, 900957003, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94143, United States
Northwestern Univ / SOCA
Chicago, Illinois, 60611, United States
Johns Hopkins Hosp / SOCA
Baltimore, Maryland, 212879217, United States
New York Univ Med Ctr / SOCA
New York, New York, 10016, United States
New York Hosp - Cornell Med Ctr / Sloan - Kettering / SOCA
New York, New York, 10021, United States
Mount Sinai Med Ctr / SOCA
New York, New York, 100296574, United States
Univ of North Carolina / SOCA
Chapel Hill, North Carolina, 275997030, United States
Related Publications (1)
Jabs DA. Design of clinical trials for drug combinations: cytomegalovirus retinitis--foscarnet and ganciclovir. The CMV retinitis retreatment trial. Antiviral Res. 1996 Jan;29(1):69-71. doi: 10.1016/0166-3542(95)00921-3.
PMID: 8721550BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Primary Completion
September 1, 1995
Last Updated
March 1, 2011
Record last verified: 2011-02