- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000836
A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)
To compare the safety and efficacy of sevirumab (MSL 109; Protovir), human anti-cytomegalovirus (CMV) monoclonal antibody, plus active primary treatment versus placebo plus active primary treatment in AIDS patients with newly diagnosed and relapsed CMV retinitis.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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La Jolla, California, United States, 920930946
- UCSD - Shiley Eye Ctr / SOCA
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Los Angeles, California, United States, 900957003
- UCLA - Jules Stein Eye Institute / SOCA
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San Francisco, California, United States, 94143
- UCSF - San Francisco Gen Hosp
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Univ / SOCA
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Maryland
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Baltimore, Maryland, United States, 212879217
- Johns Hopkins Hosp / SOCA
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New York
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New York, New York, United States, 10016
- New York Univ Med Ctr / SOCA
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Study record dates
Study Major Dates
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACTG 294
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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