Overview

Cell Mediated Immunity for Secondary Prophylaxis in CMV SOT Patients

Status:
Completed
Trial end date:
2017-06-16
Target enrollment:
0
Participant gender:
All
Summary
This study will evaluate whether a test for Cytomegalovirus (CMV) specific cell-mediated immunity can be used to determine whether patients who complete a course of therapy for CMV viremia need secondary antiviral prophylaxis. Subjects that have negative CMV CMI will receive antiviral prophylaxis for 2 months and those with positive CMV CMI will have their prophylaxis stopped.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Health Network, Toronto
Treatments:
Ganciclovir
Ganciclovir triphosphate
Valganciclovir
Criteria
Inclusion Criteria:

- Adult solid organ transplant (SOT) recipient on at least one immunosuppressive
medication

- Starting therapy for new onset asymptomatic CMV viremia OR starting therapy for new
onset CMV disease

- CMV viral load ≥ 1000 IU/mL

Exclusion Criteria:

- Known ganciclovir-resistant CMV

- Known intolerance to valganciclovir or ganciclovir

- Unable to comply with protocol