Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients

Completed · Phase 2

Conditions studied: Cytomegalovirus (CMV)

In brief

This study will assess safety, antiviral activity, and pharmacokinetics of different doses of maribavir administered orally for up to 24 weeks for treatment of CMV infections that are resistant or refractory to treatment with ganciclovir/valganciclovir or foscarnet in recipients of stem cell or solid organ transplants.

Key facts

Study ID

NCT01611974

Run by

Shire

People needed

120

Starts

2012-07-17

Expected to finish

2014-12-05

Last updated by the study team

2021-06-02

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be ≥12 years of age.
• Weigh ≥ 40 kg.
• Be a recipient of stem cell or solid organ transplantation.
• Have documented CMV infection in blood or plasma, with a screening value of ≥1,000 DNA copies/mL.
• Have a current CMV infection that is resistant (known CMV genetic mutations) or refractory (clinical failure to respond) to treatment with ganciclovir/valganciclovir and/or foscarnet.
• If female, be either postmenopausal, surgically sterile, or have a negative pregnancy test prior to randomization.
• Be able to swallow tablets.
• If adult, provide written informed consent. If child (age <18 years), have a parent/legal guardian who is willing and able to provide written informed consent (with assent from the child when appropriate).
• Be assessed by the investigator to determine whether prophylaxis for non-CMV herpesvirus infections (e.g., herpes simplex virus [HSV type 1 and type 2] and varicella zoster virus [VZV]) is appropriate according to institutional guidelines or standard practices, keeping in mind that maribavir is not active in vitro against these viruses.

You may not qualify if…

• Be receiving any other anti-CMV agent(s).
• Have a current CMV infection that is considered resistant or refractory due to inadequate adherence to prior oral anti-CMV treatment.
• Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the time of enrollment.
• Have severe hepatic impairment.
• Require mechanical ventilation or vasopressors for hemodynamic support at the time of enrollment.
• Have expected survival less than 6 weeks.
• Be pregnant or breastfeeding.
• Other clinically significant medical or surgical condition.

Where it is running

• UCLA Medical Center — Los Angeles, California, United States
• Stanford University Medical Center — Stanford, California, United States
• University of Colorado — Denver, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University Medical Center — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Massachusetts — Worcester, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Health Care System — Detroit, Michigan, United States
• University of Minnesota Medical Center — Minneapolis, Minnesota, United States
• University of Nebraska — Omaha, Nebraska, United States
• Columbia University — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Wake Forest Medical Center — Winston-Salem, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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