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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004642
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: March 1999
  Purpose

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 Intervention Phase
Cytomegalovirus Infections
Drug: SDZ MSL-109
Phase 1
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Study Start Date: February 1995
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.

  Eligibility

Ages Eligible for Study:   up to 29 Days
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004642

Sponsors and Collaborators
Investigators
Study Chair: Richard J. Whitley
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004642     History of Changes
Other Study ID Numbers: 199/11673, NIAID-3748
Study First Received: February 24, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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:
Central Nervous System Diseases
Cytomegalovirus Infections
Nervous System Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014