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

• ClinicalTrials.gov Identifier: NCT00004642
• Recruitment Status: Completed
• First Posted: February 25, 2000
• Last Update Posted: June 24, 2005
• Sponsor: National Center for Research Resources (NCRR)
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by: Office of Rare Diseases (ORD)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cytomegalovirus Infections	Drug: SDZ MSL-109	Phase 1; Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: February 1995

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: up to 29 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Sponsors and Collaborators

National Center for Research Resources (NCRR)

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Study Chair: Richard J. Whitley

More Information

• ClinicalTrials.gov Identifier: NCT00004642 History of Changes
• Other Study ID Numbers: 199/11673; NIAID-3748
• First Posted: February 25, 2000
• Last Update Posted: June 24, 2005
• Last Verified: March 1999

Keywords provided by Office of Rare Diseases (ORD):

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

Additional relevant MeSH terms:

Cytomegalovirus Infections; Infection; Communicable Diseases; Central Nervous System Diseases; Nervous System Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Antibodies; Antibodies, Monoclonal; Immunologic Factors; Physiological Effects of Drugs