CytoGam for CMV Infection or Disease in Solid Organ Transplant Recipients

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 followed until 2 weekly negative CMV PCRs, discontinuation of antiviral, or 1 year from CytoGam infusion, whichever is longer. CMV D+/R- liver transplant recipients on pre-emptive therapy who develop any level of detectable CMV DNAemia 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 followed until 2 weekly negative CMV PCRs, discontinuation of antiviral, or 1 year from CytoGam infusion, whichever is longer. Recipients of any solid organ transplant who have CMV DNAemia ≥ 50,000 IU/ml, with or without CMV disease, and who have not yet received antiviral therapy 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 followed until 2 weekly negative CMV PCRs, discontinuation of antiviral, or 1 year from CytoGam infusion, whichever is longer.