NCT00004642

Phase I/II Study of Human Anti-Cytomegalovirus (CMV) Monoclonal Antibody MSL-109 in Newborns With Symptomatic Congenital CMV Infection Without Central Nervous System Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: All
• Age: 0 Years – 29 Days
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: I. Evaluate the safety, tolerance, and potential efficacy of 3 doses of human anti-cytomegalovirus (CMV) monoclonal antibody SDZ MSL-109 (MOAB MSL-109) in the treatment of newborns with congenital CMV infection and no central nervous system disease. II. Determine the relationship between plasma concentrations of MOAB MSL-109 and therapeutic outcome. III. Determine whether MOAB MSL-109 influences the antibody response and clearance of virus from the urine.

Detailed description

PROTOCOL OUTLINE: Patients are treated with human anti-cytomegalovirus monoclonal antibody MSL-109, administered intravenously every other week for a total of 3 doses. Groups of 6 patients are treated at each of 3 MSL-109 doses; there is no intrapatient escalation. No concurrent therapy with antibiotics for systemic infection, parenteral antifungal agents, biological response modifiers, or other antiviral agents is allowed. Patients are followed every 2 weeks for 6 weeks, every 4 weeks for 12 weeks, then annually for 5 years.

Conditions

• Cytomegalovirus Infections

Interventions

Type	Name	Description
DRUG	SDZ MSL-109

Timeline

• Start date: 1995-02-01
• First posted: 2000-02-25
• Last updated: 2005-06-24