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

NCT00004642 | Completed Phase 1

• 2 other identifiers: 199/11673NIAID-3748
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cytomegalovirus Infections

Keywords

congenital cytomegalovirus infection; cytomegalovirus infection; herpesvirus infection; immunologic disorders and infectious disorders; neonatal disorders; rare disease; viral infection

Interventions

SDZ MSL-109 DRUG

Eligibility Criteria

• Age: 0 Years - 29 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Symptomatic congenital cytomegalovirus (CMV) infection confirmed by urine culture No CMV acquired natally or postnatally Normal eye exam and skull x-ray, computerized tomography, or magnetic resonance imaging No evidence of central nervous system CMV, e.g.: Microcephaly, hydrocephaly, or hydranencephaly Intracranial calcification Chorioretinitis Normal cerebrospinal fluid Preterm: WBC no greater than 30 Protein less than 120 mg/dL Term: WBC no greater than 25 Protein less than 80 mg/dL --Prior/Concurrent Therapy-- At least 2 weeks since investigational drugs No prior or concurrent antiviral agents --Patient Characteristics-- Life expectancy: No imminent demise Renal: Creatinine no greater than 1.5 mg/dL Other: Birth weight at least 1200 g No congenital toxoplasmosis, congenital rubella, or syphilis No active systemic infection, i.e.: Bacterial Non-CMV viral, including HIV Protozoal Fungal No severe concurrent clinical condition, e.g.: Non-CMV congenital disease Genetic abnormality Moderate to severe hyaline membrane disease

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

MeSH Terms

Conditions

Cytomegalovirus Infections; Herpesviridae Infections; Immune System Diseases; Communicable Diseases; Infant, Newborn, Diseases; Rare Diseases; Virus Diseases

Interventions

sevirumab

Condition Hierarchy (Ancestors)

DNA Virus Infections; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Richard J. Whitley

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 24, 2000
• First Posted: February 25, 2000
• Study Start: February 1, 1995
• Last Updated: June 24, 2005

Record last verified: 1999-03