Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients

Condition(s) studied

Investigational drug(s) / intervention(s)

Letermovir: 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: 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.

Valganciclovir/Ganciclovir: 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

Study 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

Primary outcome measure(s)

• Proportion of patients achieving clearance of CMV viremia by week 3, as measured by quantitative PCR. — From time of enrollment until 3 weeks after enrolment
  Viral clearance is described by a plasma CMV viral load \< 200 IU/mL, the UHN clinically used threshold

Trial sites (1)

More University Health Network, Toronto trials in Canada

Other trials for the same condition