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
SDZ MSL-109
Infections par virus ADN+10
+ Infections
+ Maladies et anomalies congénitales, héréditaires et néonatales
Étude thérapeutique
Résumé
Date de début de l'étude : 1 février 1995
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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