A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)
Sevirumab
Blood-Borne Infections+24
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 6 locations
UCLA - Jules Stein Eye Institute / SOCA
Los Angeles, United StatesUCSF - San Francisco Gen Hosp
San Francisco, United StatesNorthwestern Univ / SOCA
Chicago, United States