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