Pilot Study of Letermovir Combined with Standard Antiviral Treatment for Cytomegalovirus Infection in Lung Transplant Patients

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.

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