Completed
CMV Retinitis Retreatment Trial
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2011-03-01
300
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CMV Retinitis Retreatment Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 9 locations
1
UCSD - Shiley Eye Ctr / SOCA
La Jolla, California, United States, 920930946
Status Unknown
2
UCLA - Jules Stein Eye Institute / SOCA
Los Angeles, California, United States, 900957003
Status Unknown
3
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94143
Status Unknown
4
Northwestern Univ / SOCA
Chicago, Illinois, United States, 60611
Status Unknown
5
Johns Hopkins Hosp / SOCA
Baltimore, Maryland, United States, 212879217
Status Unknown
6
New York Univ Med Ctr / SOCA
New York, New York, United States, 10016
Status Unknown
7
New York Hosp - Cornell Med Ctr / Sloan - Kettering / SOCA
New York, New York, United States, 10021
Status Unknown
8
Mount Sinai Med Ctr / SOCA
New York, New York, United States, 100296574
Status Unknown
9
Univ of North Carolina / SOCA
Chapel Hill, North Carolina, United States, 275997030
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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