A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cytomegalovirus Retinitis; HIV Infections
Intervention: Sevirumab (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Summary
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.
Clinical Details
Official title: A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)
Study design: Primary Purpose: 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.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
UCSD - Shiley Eye Ctr / SOCA, La Jolla, California 920930946, United States
UCLA - Jules Stein Eye Institute / SOCA, Los Angeles, California 900957003, United States
UCSF - San Francisco Gen Hosp, San Francisco, California 94143, United States
Northwestern Univ / SOCA, Chicago, Illinois 60611, United States
Johns Hopkins Hosp / SOCA, Baltimore, Maryland 212879217, United States
New York Univ Med Ctr / SOCA, New York, New York 10016, United States
Additional Information
Last updated: October 24, 2012
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