Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients
Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients: A Pilot Trial
University Health Network, Toronto
40 participants
Dec 24, 2025
INTERVENTIONAL
Conditions
Summary
The primary objective of the CLEAR-CMV trial is to evaluate the efficacy of letermovir therapy plus standard of care (SOC) antiviral compared to SOC plus placebo in achieving clearance of CMV viremia by week 3 in lung transplant recipients with active CMV infection.
Eligibility
Inclusion Criteria2
- Recipient of a lung transplant.
- Has confirmed CMV viremia with a viral load ≥ 1000 IU/mL and will receive or has just started SOC antiviral treatment in the past 72h as per the decision of the treating physician.
Exclusion Criteria8
- Renal failure with Creatinine clearance \<15 mL/min or requiring dialysis
- Severe hepatic impairment (Child-Pugh Class C)
- Participating in another interventional clinical trial
- Combined transplant (e.g heart-lung, lung-liver)
- Known allergy or contraindication to any of the antiviral medications
- Known antiviral resistance.
- Patient receiving cyclosporin, pimozide or ergot alkaloids (due to significant drug interaction with letermovir).
- Patient receiving or expected to receive CMV immunoglobulin or IVIG during the initial three week treatment phase
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Interventions
Letermovir (480mg) will be given orally as a loading dose every 12 hours for the first 24 hours, then one tablet per day for a total treatment duration of 21 days. Letermovir treatment will be started within 72 hours of starting SOC antiviral treatment as per the decision of the treating physician.
Placebo will be dosed the same as letermovir: one tablet every 12 hours for the first 24 hours, then one tablet per day for total treatment duration of 21 days.
Ganciclovir or its oral prodrug, valganciclovir will be administered as the standard of care antiviral therapy. Its duration will be at the discretion of the treatment physician but is typically given until clearance of viremia. The clinical definition of viral clearance is one negative viral load or two viral loads one week apart that are \<200 IU/mL
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07235683