Fernanda P Silveira, MD, MS
Cytomegalovirus (CMV) is a significant opportunistic pathogen and a major cause of morbidity and mortality in solid organ transplant recipients. CytoGam - Cytomegalovirus Immune Globulin Intravenous (CMV-IGIV), is an immunoglobulin G containing a standardized amount of antibody against CMV. CytoGam is obtained from pooled adult human plasma that has been selected for high anti-CMV titers. This study will evaluate if administration of CytoGam to organ transplant recipients with CMV infection, along with standard of care antiviral medication, leads to faster clearance of CMV from the blood, prevents the development of antiviral resistance, and decreases the rate of recurrence of CMV infection.
Interventional, open-label, single center, pilot study to test the effect of CytoGam on CMV viremia clearance in organ transplant recipients with high CMV viral load and in CMV D+/R- lung and liver transplant recipients with primary CMV infection. CMV D+/R- lung transplant recipients who develop any level of CMV DNAemia after discontinuation of valganciclovir prophylaxis and who have not yet received antiviral treatment for greater than 14 days will receive one dose of CytoGam. The choice and duration of antiviral therapy will be at the discretion of the treating physician. Patients will be f…
Inclusion Criteria - all study arms: * Written informed consent obtained from the subject before any trial-related procedures are performed * \>= 18 years and \<= 75 years of age at time of consent * Able to perform routine blood testing (standard care for transplant recipients) * Understands and can read English Inclusion criteria - high viral load arm: * Recipient of an organ transplant (lung, heart, liver, kidney, pancreas, intestine alone or in combination) and on immunosuppression * CMV DNAemia ≥ 50,000 IU/ml in the first 2 weeks of CMV antiviral treatment with CMV antiviral dose appro…
CytoGam 150 mg/kg intravenously (IV) administered as a single dose
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