Study of Everolimus and Mycophenolate Mofetil to Reduce Cytomegalovirus Viral Load in Solid Organ Transplant Recipients

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What is this study about?

Cytomegalovirus infection is a viral illness that can become serious in people who have received a solid-organ transplant, because their immune system is intentionally weakened to prevent organ rejection. In this situation the virus can multiply in the blood, a measurement known as viral load. The trial compares two ways of adjusting the medicines that suppress the immune system: either cutting the dose of mycophenolate mofetil in half or replacing it with the drug everolimus, while participants continue to take the usual antiviral medication that fights the virus.

The purpose of the study is to see if this immune modulation approach lowers the amount of virus in the blood compared with keeping the standard drug regimen. Participants will be assigned to one of the two adjustment strategies or to continue their current treatment, and their virus levels will be checked at the start and again after a few weeks. Additional blood tests will look at how the immune system responds to the virus, and the data will help determine whether the new strategies are effective.

1 join the trial

after providing consent, you become a participant in the horus‑cmv open proof‑of‑concept exploratory trial.

2 baseline assessment

on the first day, blood is drawn to measure the amount of cmv virus and to assess immune markers.

your current medication list is recorded and any required antiviral therapy is continued.

3 randomization to treatment group

based on a computer system, you are assigned to one of three groups: continue usual medication, receive a reduced dose of mycophenolate mofetil, or switch to everolimus.

4 start of study medication

if you remain on the usual regimen, you continue taking mycophenolate mofetil 3000 mg taken by mouth each day.

if you are in the reduced‑dose arm, you take mycophenolate mofetil 1500 mg (half of the usual dose) each day.

if you are in the everolimus arm, you stop mycophenolate mofetil and begin everolimus 3 mg taken by mouth each day.

the assigned medication is taken daily for the entire study period.

5 regular monitoring visits

you attend clinic visits each week for the first three weeks.

at each visit a blood sample is taken to check the cmv viral load and to monitor safety.

the study team may adjust other medicines if needed, but the study medication dose remains the same.

6 week 3 evaluation

at the end of week 3 a final blood test measures the change in cmv viral load compared with the baseline value.

the results are used to determine the primary outcome of the trial.

7 continued follow‑up

after week 3 you continue to take the assigned medication and attend any additional visits required by the protocol until the trial ends.

final assessments are performed at the study’s scheduled end date.

Who Can Join the Study?

Clinically stable adult patients (age 18 or older) who have received a solid organ transplant such as a kidney, liver, heart, lung, or pancreas, and who now have a significant cytomegalovirus (CMV) infection confirmed by a positive CMV PCR test. CMV PCR is a laboratory test that looks for the virus’s genetic material in the blood.
Currently taking a maintenance immunosuppressive regimen that includes tacrolimus and mycophenolic acid (MPA), with or without steroids. Tacrolimus and MPA are medicines that help prevent the body from rejecting the transplanted organ, and steroids are anti‑inflammatory drugs sometimes used for the same purpose.
Has signed an informed consent form agreeing to take part in the study.

Who Cannot Join the Study?

Having an active acute graft rejection (your body attacking the transplanted organ) or a serious graft dysfunction (the transplanted organ not working well) that would require your doctor to change the current immune‑suppressing medicines.
Having taken more than 72 hours (three days) of antiviral therapy for the CMV infection before joining the study, including medicines such as valganciclovir or IV ganciclovir (ganciclovir given through a vein).
Being known to have an intolerance or an allergic reaction (hypersensitivity) to mTOR inhibitors (a group of drugs that lower immune activity) or to any ingredient in the drug everolimus.
Having any medical condition that makes using everolimus unsafe (contraindication) according to your doctor’s judgment.
For study sites in France only: not being part of the French social security system (no health coverage) or being under legal protection such as guardianship or curatorship (someone else makes legal decisions for you).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.06.2026

Trial locations

Investigated Drugs:

Everolimus is a pill taken by mouth that helps control the immune system. In this study, it is being tested as an alternative to the usual medicines that suppress immunity after a transplant. Researchers want to see if using everolimus can lower the amount of cytomegalovirus (CMV) in the blood, because a less active immune system can sometimes let the virus grow. Participants who receive everolimus will continue their antiviral treatment, and the trial will compare how well their virus levels improve compared with those staying on the standard regimen.

Mycophenolate mofetil (listed in the trial as Mycophenolic Acid) is a medication taken by mouth that also weakens the immune system to prevent organ rejection. In this trial, patients will keep taking mycophenolate mofetil but at a reduced dose—about half of their usual amount. The goal is to find out whether lowering the dose can still protect the transplanted organ while also reducing the amount of CMV virus in the body. Like the other group, these participants will also receive antiviral therapy, and their virus levels will be compared to those who do not change their medication.

Cytomegalovirus infection in solid organ transplant recipients – Cytomegalovirus infection in solid organ transplant recipients is a viral illness that occurs when the CMV virus reactivates or is newly acquired after transplantation. Because the immune system is suppressed to prevent organ rejection, the virus can replicate more easily. The infection often begins with mild fever, fatigue, and low white‑blood‑cell counts, and may spread to the gastrointestinal tract, lungs, or eyes. As the viral load increases, symptoms can become more pronounced, including diarrhea, cough, or visual disturbances. Without control, the virus can cause ongoing inflammation that may affect the transplanted organ and other body systems.

Trial ID:

2025-524845-28-00

Protocol code:

HORUS-COPE

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Everolimus and Mycophenolate Mofetil to Reduce Cytomegalovirus Viral Load in Solid Organ Transplant Recipients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?