Letermovir for R+ Study

NCT07706166 — Phase 4, Not yet recruiting, 146 participants, University of Wisconsin, Madison

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An Interventional Study of Letermovir for Primary Prophylaxis of Cytomegalovirus Infection in Moderate Risk (R+) Abdominal Solid Organ Transplant Recipients

Registry	NCT07706166, acronym MISP CMV
Status	Not yet recruiting
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, prevention
Enrollment	146 (Estimated)
Sponsor	University of Wisconsin, Madison (Other); collaborators: Merck Sharp & Dohme LLC
Conditions	Kidney Transplant, Liver Transplant
Interventions	Letermovir (Drug)
Dates	start 2026-10-01 (estimated), primary completion 2029-09-01 (estimated), completion 2029-09-01 (estimated), first posted 2026-07-15, last updated 2026-09-29
Locations	1 site in United States

-Summary

The purpose of this clinical trial is to find out whether a medication, called letermovir, can help prevent a virus called cytomegalovirus (CMV) in participants who receive a kidney or liver transplant and who have already been exposed the CMV.

Participants will take letermovir for 84 days.

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+Detailed description

This study is being done to see if letermovir prevents CMV reactivation in seropositive participants with a kidney or liver transplant.

+Arms and interventions

Arm	Type	Interventions	Description
Receive letermovir	Experimental	Drug: Letermovir	Participants will take letermovir

Letermovir (Drug): 1 tablet by mouth, once daily, for 84 days

+Outcome measures

Primary outcomes

Efficacy of letermovir as a prophylaxis of CMV [84 days]: Efficacy will be measured through comparative rates of antiviral failure. Failure will be defined as withdrawal due to intolerance or breakthrough viral replication to a viral load >1000 IU/mL.

Secondary outcomes

Percentage of participants who develop cytomegalovirus-specific cell-mediated immunity [84 days]: To be measured using the Eurofins-Viracor CMV inSIGHT™ T Cell Immunity testing. The test measures the strength of T cell responses to Cytomegalovirus (CMV) specific antigens.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Adults who are at moderate risk for CMV after transplant (CMV IGG+, including D+/R+ or D-/R+)
* Adults who received a kidney transplant, liver transplant, or any combination thereof

Exclusion Criteria:

* Known contraindication to letermovir or its excipients
* Current participation in another CMV related study
* Unwilling or unable to participate in the study protocol

+Locations (1)

Facility	City	Country	Status
University of Wisconsin - Madison	Madison, Wisconsin	United States

+Investigators

David Al-Adra, MD, Principal investigator, University of Wisconsin, Madison