A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)
NCT ID: NCT00000836
Last Updated: 2012-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
300 participants
INTERVENTIONAL
1998-08-31
Brief Summary
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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.
Detailed Description
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Patients are randomized to receive either MSL 109 or placebo every 2 weeks as supplemental therapy to primary CMV treatment.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Sevirumab
Eligibility Criteria
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Inclusion Criteria
* 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
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.
13 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Locations
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UCSD - Shiley Eye Ctr / SOCA
La Jolla, California, United States
UCLA - Jules Stein Eye Institute / SOCA
Los Angeles, California, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, United States
Northwestern Univ / SOCA
Chicago, Illinois, United States
Johns Hopkins Hosp / SOCA
Baltimore, Maryland, United States
New York Univ Med Ctr / SOCA
New York, New York, United States
Countries
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Other Identifiers
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ACTG 294
Identifier Type: -
Identifier Source: org_study_id