Status:
COMPLETED
CMV Retinitis Retreatment Trial
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Cytomegalovirus Retinitis
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Detailed Description
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, deterioratin...
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00000766
Last Update
March 1 2011
Active Locations (9)
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1
UCSD - Shiley Eye Ctr / SOCA
La Jolla, California, United States, 920930946
2
UCLA - Jules Stein Eye Institute / SOCA
Los Angeles, California, United States, 900957003
3
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94143
4
Northwestern Univ / SOCA
Chicago, Illinois, United States, 60611