A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)
1 other identifier
interventional
300
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
August 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 25, 2012
October 1, 2012
November 2, 1999
October 24, 2012
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
August 1, 1998
Last Updated
October 25, 2012
Record last verified: 2012-10