Actively Recruiting
Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients: A Pilot Trial
Led by University Health Network, Toronto · Updated on 2026-02-17
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial focuses on lung transplant recipients who are at high risk for cytomegalovirus (CMV) infection due to their need for strong immunosuppressive medications. The study aims to compare the effectiveness of combining letermovir with standard antiviral therapy versus standard antiviral therapy plus placebo in clearing CMV from the blood by the third week after starting treatment. The trial addresses important issues like CMV-related complications and resistance to current treatments. Participants will be randomly assigned to one of two groups: one receiving standard antiviral care plus a placebo, and the other receiving standard antiviral care plus letermovir. Letermovir is given as a 480 mg oral loading dose every 12 hours for the first day, then once daily for three weeks. The duration and dosage of standard antiviral therapy, which includes ganciclovir or valganciclovir, will be decided by the treating physician. The study uses a quadruple masking method to keep participants and researchers unaware of group assignments. During the study, participants will have their CMV viral load monitored through blood tests at enrollment, week 3, and up to six months after enrollment. Researchers will track how many patients clear the virus by week 3, the time it takes to clear the virus, symptom resolution, antiviral resistance, adverse events, and any CMV recurrence. The total follow-up period for each participant can last up to six months, allowing detailed evaluation of treatment effects and safety.
CONDITIONS
Brief Title
Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recipient of a lung transplant
- Confirmed CMV viremia with a viral load of 1000 IU/mL or higher
- Started or will start standard antiviral treatment within the past 72 hours as decided by the treating physician
You will not qualify if you...
- Renal failure with creatinine clearance less than 15 mL/min or requiring dialysis
- Severe liver impairment (Child-Pugh Class C)
- Participation in another interventional clinical trial
- Combined organ transplant (e.g., heart-lung, lung-liver)
- Known allergy or contraindication to any antiviral medications
- Known antiviral resistance
- Current use of cyclosporin, pimozide, or ergot alkaloids
- Receiving or expected to receive CMV immunoglobulin or IVIG during the initial three-week treatment phase
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.
1 visit (in-person)
Duration - 21 days
Participants receive standard antiviral therapy combined with either letermovir or a placebo for the treatment of CMV infection.
Daily medication with treatment started within 72 hours of SOC antiviral initiation
Duration - Up to 6 months
Participants are monitored for up to 6 months after treatment to assess viral clearance, symptom resolution, antiviral resistance, adverse events, and CMV recurrence.
Visits and assessments as scheduled up to 6 months post-treatment
Trial Site Locations
Total: 1 location
1
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
Research Team
A
Atul Humar, MD, FRCPC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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