CMV Retinitis Retreatment Trial
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 11, 2025
Completed
Keywords
ClinConnect Summary
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.
Patients are randomized to receive foscarnet, ganciclovir, or a combination of the two drugs (administered sequentially). Initially, patients undergo single or multiple cycles of induction therapy for 14 days followed by mainte...
Gender
ALL
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.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
San Francisco, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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