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CMV Immunity Monitoring in Lung Transplant Recipients
Sponsor: NYU Langone Health
Summary
The purpose of this study is to determine the safety and feasibility of using a laboratory test to guide duration of antiviral prophylaxis with valganciclovir (medication used to prevent viral infections) after lung transplant. The laboratory test, inSIGHT™ CMV T Cell Immunity Panel, measures patients' immune response to a common viral infection known as cytomegalovirus (CMV). The goal of this study will be to safely decrease how long patients need to take valganciclovir based on the results of the CMV T Cell Immunity Panel.
Official title: Cytomegalovirus T Cell Immunity and Antiviral Prophylaxis Minimization in Lung Transplant Recipients
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-09-13
Completion Date
2026-09
Last Updated
2025-07-30
Healthy Volunteers
No
Conditions
Interventions
Cytomegalovirus T Cell Immunity Panel (CMV-TCIP)
Whole blood assay that evaluates T cell (CD4 and CD8) responses to cytomegalovirus (CMV) antigens via intracellular cytokine staining (ICS).
Donor-Derived Cell-Free DNA (dd-cfDNA) Assay
Determines the percentage of circulating cell-free DNA (cfDNA) in transplant recipients derived from donor grafts.
Valganciclovir
Delivered as standard of care for post-lung transplant immunosuppression and infection prophylaxis. Started on the first day post-transplant at a standard dose of 900 mg daily and continued for 12 months. Dose adjustments may be necessary based on renal function and/or adverse effects (e.g. neutropenia). Dose adjustments are standard based on package insert recommendations.
Locations (1)
NYU Langone Health
New York, New York, United States