Conditions: Cytomegalovirus Disease
Keywords: CMV cytomegalovirus transplant
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: no

Brief summary:
The purpose of the study is to assess the incidence and severity of late Cytomegalovirus (CMV) disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and 200 days and after 200 days post-transplant in patients treated with valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant versus valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant.

Detailed description:

Arms:
arm 1: valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant arm 2: valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection

Interventions: intervention 1: Valganciclovir intervention 2: CMV hyperimmune globulin intervention 3: Valganciclovir
Intervention descriptions: intervention 1: Valcyte per package insert guidelines for 200 days post transplant intervention 2: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant intervention 3: valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant

Protocol document: