A Study of Maribavir for Cytomegalovirus Infection in Stem Cell Transplant Patients Who Cannot Take or Did Not Tolerate Standard Treatment

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What is this study about?

This study involves patients who have received a hematopoietic stem cell transplant, which is a procedure where stem cells are transferred from a donor to replace damaged bone marrow, and who have developed a cytomegalovirus infection. Cytomegalovirus is a common virus that can cause serious complications in people with weakened immune systems, such as those who have had a stem cell transplant. The treatment being studied is maribavir, which is an antiviral medication that works against this virus. This medication will be given to two groups of patients: those who cannot receive the usual antiviral drugs called ganciclovir, valganciclovir, or foscarnet because of other medical conditions that make these drugs unsafe for them, and those who had to stop taking these usual drugs because they experienced harmful side effects or could not tolerate them.

The purpose of this study is to evaluate how well maribavir works in treating cytomegalovirus infection in these patients and to assess what side effects might lead to stopping the treatment. The study will measure success by checking whether the amount of virus in the blood drops to very low levels that cannot be easily measured after eight weeks of treatment. The medication is taken by mouth in the form of film-coated tablets, with a maximum daily dose of 800 milligrams, and treatment can continue for up to twelve weeks.

During the study, patients will have regular blood tests to measure the amount of virus in their blood and to monitor for any side effects. The study will track how many patients respond to the treatment within eight weeks and will also follow patients for an additional eight weeks after they stop taking the medication to see if the virus returns. Some patients who show partial improvement at eight weeks may continue treatment for up to twelve weeks to see if they achieve a better response. The study will also record any side effects that occur during treatment, particularly those that are serious enough to require stopping the medication.

1 Treatment initiation

The treatment will begin once enrollment in the study is complete.

The medication used in this study is maribavir, which is an antiviral drug designed to treat cytomegalovirus infection. Cytomegalovirus is a common virus that can cause serious complications after a stem cell transplant.

The medication comes in the form of film-coated tablets that are taken by mouth.

Each tablet contains 200 mg of the active substance maribavir.

The treatment is provided either as a first option if other standard antiviral medications cannot be used due to medical reasons, or as a second option if previous treatment with other antiviral medications had to be stopped due to side effects or poor tolerance.

2 Active treatment period

The treatment with maribavir will continue for a period of 8 weeks.

The tablets must be swallowed whole. The ability to swallow tablets is required for participation.

During this period, blood samples will be taken regularly to measure the level of cytomegalovirus DNA in the blood. This measurement helps determine whether the virus is responding to the treatment.

The goal is to reduce the virus level in the blood to below the lower limit of quantification, which means the virus is present in such small amounts that it can barely be detected. This result needs to be confirmed in at least two consecutive blood tests.

3 Assessment at 8 weeks

At the end of the 8-week treatment period, an evaluation will be performed to determine the response to treatment.

A successful response is defined as having the virus level in the blood below the detectable limit, confirmed by at least two consecutive tests.

If there is a partial response at 8 weeks, meaning some improvement but the virus is still detectable, the treating physician may decide to continue the treatment for an additional period.

Any side effects experienced during treatment will be documented, particularly those that are moderate to severe or those that require stopping the medication.

4 Extended treatment period (if applicable)

If the treating physician determines that continuing treatment is appropriate based on the response at 8 weeks, the medication may be continued for up to 12 weeks in total.

This extended period allows additional time for the virus level to decrease to the target range.

Blood monitoring will continue during this extended period to track the virus level and assess the response.

5 Follow-up after treatment completion

After stopping the maribavir treatment, monitoring will continue for an additional 8 weeks.

During this follow-up period, blood tests will be performed to check whether the virus remains at low levels or if it returns.

This monitoring helps evaluate the durability of the treatment response and whether the virus reappears after the medication is stopped.

For women of childbearing potential, effective contraception must be used for at least 1 month after taking the last dose of maribavir.

Who Can Join the Study?

Requirements to participate in this study:

You must be older than 18 years of age
You must weigh at least 40 kilograms (about 88 pounds)
You must have received an allogeneic hematopoietic stem cell transplant (a procedure where you received blood-forming stem cells from a donor) within the past twelve months
You must have a diagnosis of CMV infection (an infection caused by a virus called cytomegalovirus)
You must have a medical condition that makes it unsafe to take standard antiviral drugs called ganciclovir, valganciclovir, or foscarnet, such as kidney problems, bone marrow problems, or previous bad reactions to these medicines, OR you must have stopped taking these standard antiviral drugs because they caused harmful side effects or you could not tolerate them
You must not have diarrhea, other intestinal symptoms, or active intestinal disease
You must be able to swallow tablets
Your life expectancy must not be severely limited by other illnesses
Your performance status (a measure of how well you can perform daily activities) must be less than 3 on the ECOG scale (a scoring system from 0 to 5, where lower numbers mean better ability to function)
Your liver must be functioning adequately, with bilirubin (a substance produced by the liver) levels no higher than 2 times the upper normal limit, and liver enzymes called ALT and AST no higher than 2.5 times the upper normal limit
Your kidneys must be functioning adequately, with creatinine clearance (a measure of how well your kidneys filter waste) of at least 50 milliliters per minute
If you are a woman who can become pregnant, you must use highly effective birth control methods for at least 1 month after your last dose of the study drug
You must be willing and able to follow all study requirements and attend all scheduled visits
You must provide written informed consent (formal agreement to participate after understanding the study)

Who Cannot Join the Study?

The study does not list specific exclusion criteria in the provided information
If you have questions about whether you can participate in this study, you will need to discuss your individual medical situation with the research team during the screening process
The research doctors will review your complete medical history and current health status to determine if this study is appropriate for you

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Azienda Ospedaliera Di Perugia	Perugia	Italy
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli	Reggio Calabria	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
ARNAS G. Brotzu	Cagliari	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Atzdnws Owwrrtwuajz Oyyswjmc Rszzcel Viiuz Slsev Cjcpnalw	Palermo	Italy
Aevwync Ogswmazwfpb Udevcmqoyznqt Ckewiywrtvzf Dzerb Svmlwn E Dccfg Semjegb Dc Tuhpty	Turin	Italy
Aejhkac Oxgjlqkizpi Nmaghrmas Sl Avehzix E Byvfey E C Azogkq Ajbmdclmhah	Alexandria	Italy
Asicfam Uwojp Sbtsuelrw Lofonr Dy Bmbtmqy	Bologna	Italy
Advcbyf Ohcpjiscohh Pwot Gqopvcsx Xednw	Bergamo	Italy
Uuocgalwvp Dhvsz Scxuy Dg Rcfn Lu Synooqly	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	30.09.2025

Trial locations

Investigated drugs:

Maribavir

Maribavir is an antiviral medication used to treat cytomegalovirus (CMV) infection in patients who have received a hematopoietic stem cell transplant. This medicine works by fighting the CMV virus in the body. In this study, maribavir is being tested for patients who either cannot take the standard CMV treatments due to medical reasons or who had to stop their first treatment because it caused harmful side effects or they could not tolerate it.

Ganciclovir is a standard antiviral medication commonly used to treat CMV infections. It helps stop the virus from multiplying in the body. In this trial, it is mentioned as one of the first-line treatments that some patients cannot use or had to stop taking.

Valganciclovir is another standard antiviral medication used to treat CMV infections. It works similarly to ganciclovir and is converted to ganciclovir in the body. In this study, it is mentioned as one of the first-line treatments that some patients cannot use or had to discontinue.

Foscarnet is an antiviral medication used to treat CMV infections, particularly in patients who cannot use other standard treatments. In this trial, it is mentioned as one of the first-line treatments that some patients cannot take or had to stop using due to side effects or intolerance.

Cytomegalovirus Infection – Cytomegalovirus infection is a viral disease caused by a member of the herpes virus family. The virus can remain dormant in the body for long periods and may reactivate when the immune system becomes weakened. In healthy individuals, the infection often causes no symptoms or only mild flu-like symptoms. In people with weakened immune systems, such as transplant recipients, the infection can become active and spread through the bloodstream. The virus can affect multiple organs including the lungs, liver, and digestive system. When the infection becomes active, it can be detected by measuring the amount of viral genetic material in the blood.

Trial ID:

2025-521074-34-00

Protocol code:

MARIBA-GITMO

Trial Phase:

Therapeutic exploratory (Phase II)

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A Study of Maribavir for Cytomegalovirus Infection in Stem Cell Transplant Patients Who Cannot Take or Did Not Tolerate Standard Treatment

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