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Maribavir for High Epstein-Barr Virus Infection in Young Adult Kidney Transplant Recipients

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What is this study about?

This clinical trial is studying Epstein-Barr virus infection in young adult kidney transplant recipients who have had a high level of virus activity for a long time. The treatment being tested is maribavir, given as LIVTENCITY 200 mg film-coated tablets taken by mouth. The purpose of the study is to see whether maribavir is safe and whether it can lower or clear the virus in this group of transplant patients.

The study is planned in two parts. In the first part, maribavir is taken for about 6 months. If the virus level drops but does not fall enough, treatment may continue for about 3 more months. During the study, the health of the participants and the amount of virus in the body are followed over time, along with whether the virus comes back after treatment is stopped.

Epstein-Barr virus is a common virus that can stay active in the body after infection. In people who have had a kidney transplant, the immune system is weakened to protect the new organ, and this can make it harder to control the virus. Maribavir is an antiviral medicine, which means it is designed to stop a virus from making more copies of itself.

1 start of study treatment

You begin the trial as a young adult kidney transplant recipient with a high level of Epstein-barr virus (ebv) in the blood that has remained high for more than 2 years.

You take maribavir as livtencity 200 mg film-coated tablets by mouth at a dose of 400 mg twice a day for 6 months.

The first study phase is designed to check whether this treatment can completely clear the virus or reduce the virus level by more than 50%.

2 first study phase assessment

After the first 6 months of maribavir treatment, the virus level in your blood is assessed.

If the virus is completely cleared, no further maribavir course is described in the study plan.

If the virus level has fallen by between 25% and 50%, you continue to the next study step.

3 additional maribavir treatment for selected patients

If your virus level has decreased by between 25% and 50% during the first study phase, you take maribavir 400 mg twice a day for 3 additional months.

This extra treatment is used to try to reduce the amount of virus further.

4 end of treatment evaluation

After treatment ends, the study checks whether the virus has been completely cleared.

The study also checks whether the virus comes back after maribavir is stopped.

Other study checks include the effect of treatment on the body’s virus-fighting cells in the blood and on the level of virus replication over time.

Who Can Join the Study?

  • Be between 18 and 30 years old.
  • Have had Epstein-Barr virus (EBV) infection for more than 2 years.
  • Have a very high amount of EBV in the blood, meaning more than 5 logs of EBV. This means the virus level is very high.
  • Be a solid organ transplant patient with a functioning graft. A graft is the transplanted organ, and it must still be working.
  • Have a transplanted organ that is still working well enough to take part in the study.
  • Have no previous PTLD. PTLD means a type of growth or cancer that can happen after transplant because of the immune system medicines.
  • Have a blood test showing EBV IgG positive. IgG is a type of antibody, which is a protein the body makes after exposure to EBV.
  • Have a blood test showing CMV PCR negative. PCR is a test that looks for virus genetic material, and negative means no CMV was found.
  • Be able to understand the study and give informed consent, meaning they must understand what the study involves and agree to join.
  • If female and able to become pregnant, have a negative pregnancy test at study entry.
  • If female and able to become pregnant, agree to use FDA-approved birth control for the whole study. FDA-approved means a method that has been approved as effective and safe for this purpose.

Who Cannot Join the Study?

  • Not able or not willing to give written informed consent (signed permission after the study is explained) or not able or not willing to follow the study rules.
  • Currently pregnant or breastfeeding.
  • Known active infection now, or a past history of repeated infections caused by bacteria, viruses, fungi, or mycobacteria (a type of germ), including HIV, hepatitis B, hepatitis C, or shingles (zoster).
  • Serious uncontrolled disease of a major organ, such as the heart, lungs, liver, or kidneys.
  • Any infection that needed a hospital stay and IV antibiotics (antibiotics given through a vein) within 4 weeks before screening, or oral antibiotics (antibiotics taken by mouth) within 2 weeks before screening.
  • A primary immunodeficiency or secondary immunodeficiency, meaning the immune system is missing, weak, or damaged.
  • Any malignancy (cancer) within the last 5 years, except for skin cancers called basal cell cancer and squamous cell cancer that were treated.
  • Alcohol, drug, or chemical abuse within the last 1 year.
  • Difficulty getting good peripheral venous access, meaning it is hard to place a needle into a vein in the arm for blood tests or treatment.
  • Treatment with another investigational agent (a study drug not yet approved for routine use) within 4 weeks before screening, or within 5 drug half-lives, whichever is longer. A half-life is the time it takes for half of a drug to leave the body.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Hwgavjly Vlon darydyql Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not yet recruiting
03.02.2026

Trial locations

Investigated drugs:

Maribavir is the study medicine being tested in this trial. It is taken by mouth as a tablet and is being given to kidney transplant patients who still have a high amount of Epstein-Barr virus in their blood. The goal is to see if it can lower the virus level or help clear the virus by stopping the virus from making more copies of itself. Some patients may take it for a longer time if they improve but do not have a strong enough drop in the virus level at first.

Investigated diseases:

Epstein-Barr virus infection – Epstein-Barr virus infection is a viral illness caused by the Epstein-Barr virus, which can remain in the body after the first infection. In some people, the virus can keep multiplying for a long time or return again after periods of lower activity. When this happens, the amount of virus in the blood may stay high or rise again over time.

Trial ID:
2025-524786-25-00
Protocol code:
MARIVEB
Trial Phase:
Therapeutic confirmatory (Phase III)

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