A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)
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
Ganciclovir and foscarnet are used for treatment of CMV retinitis, but cause hematologic toxicity and nephrotoxicity, respectively. Despite continued maintenance therapy with these drugs, relapse occurs in 85 percent of patients within 4 months. Studies suggest that MSL 109, a human monoclonal antibody, when given with either ganciclovir or foscarnet, may increase initial response and prolong time to progression in patients with CMV retinitis.
Patients are randomized to receive either MSL 109 or placebo every 2 weeks as supplemental therapy to primary CMV treatment.
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Concurrent Medication: Required:
- • Primary CMV treatment.
- Patients must have:
- • AIDS.
- • Active CMV retinitis.
- • At least one photographable lesion of one-quarter or more optic disc area in size.
- • Undergoing primary treatment for CMV retinitis that is not contraindicated with MSL 109.
- * Visual acuity in at least one eye of 3 or more letters on Early Treatment Diabetic Retinopathy Study ( ETDRS ) chart at 1 meter distance ( Snellen equivalent 5/200 ). Note:
- • Exceptions may be made if visual acuity impairment is possibly reversible and there is at least light perception in that eye.
- • Exclusion Criteria
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- • Retinal detachment not scheduled for surgical repair.
- • Media opacity that precludes visualization of the fundus.
- • Active medical problems sufficient to hinder study compliance.
- Concurrent Medication:
- Excluded:
- • IVIG.
- • CMV immune globulin ( CMVIG ).
- • Interferon alpha.
- • Interferon gamma.
- • Interleukin-2 ( IL-2 ).
- • Drug or alcohol abuse sufficient to hinder study 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
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials