Actively Recruiting
Cytomegalovirus T Cell Immunity and Antiviral Prophylaxis Minimization in Lung Transplant Recipients
Led by NYU Langone Health · Updated on 2026-05-29
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
V
Viracor Eurofins
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of using a laboratory test called the inSIGHT12 CMV T Cell Immunity Panel to guide how long lung transplant recipients take antiviral medication called valganciclovir. The test measures immune responses to cytomegalovirus (CMV), a common viral infection. The goal is to safely reduce the duration of antiviral treatment after lung transplant based on the patient's immune response. Participants receive the CMV T Cell Immunity Panel test every three months after their lung transplant. Those with a certain immune response level may stop taking valganciclovir earlier than the standard 12 months. Valganciclovir is given daily starting the first day after transplant at a standard dose, with adjustments as needed for kidney function or side effects. Additional tests like donor-derived cell-free DNA assays are also used to monitor the transplant. During the study, participants will be closely monitored for CMV viremia-free survival over the first year after transplant, along with occurrences of CMV viremia, treatment-resistant CMV, and other infections such as bacterial pneumonia and Aspergillus. Researchers will track blood tests, immune function, and infection status to evaluate safety and effectiveness. The study is sponsored by NYU Langone Health and will continue until May 2028.
CONDITIONS
Brief Title
CMV Immunity Monitoring in Lung Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Received a lung transplant, or multi-organ transplant involving a lung at NYU Langone Health
- Pre-existing serological immunity to CMV (R+)
- Able and willing to provide informed consent
You will not qualify if you...
- Anti-thymocyte globulin induction immunosuppression
- Perioperative desensitization
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months
Participants receive antiviral prophylaxis with Valganciclovir starting the first day post-transplant and continuing for 12 months. Dose adjustments may be made based on renal function or adverse effects.
Regular monitoring visits every 3 months for CMV-TCIP testing
Duration - Up to 12 months post-transplant
Participants are monitored for up to 12 months post-transplant for CMV viremia and related infections as part of the study outcomes.
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
T
Tyler Lewis
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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