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

Condition(s) targeted: Cytomegalovirus Infections

Intervention: Maribavir (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Shire

Official(s) and/or principal investigator(s):
Stephen A. Villano, M.D., Study Director, Affiliation: ViroPharma Incorporated

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.

Official title: A Phase 2, Randomized Study to Assess the Safety and Anti-cytomegalovirus (CMV) Activity of Different Doses of Maribavir for Treatment of CMV Infections That Are Resistant or Refractory to Treatment With Ganciclovir/Valganciclovir or Foscarnet in Transplant Recipients

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Number of subjects with treatment emergent adverse events.

Secondary outcome: Number of subjects with undetectable plasma CMV

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria 1. Be ≥12 years of age. 2. Weigh ≥ 40 kg. 3. Be a recipient of stem cell or solid organ transplantation. 4. Have documented CMV infection in blood or plasma, with a screening value of ≥1,000 DNA copies/mL. 5. 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. 6. If female, be either postmenopausal, surgically sterile, or have a negative pregnancy test prior to randomization. 7. Be able to swallow tablets. 8. 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). 9. 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. Exclusion Criteria 1. Be receiving any other anti-CMV agent(s). 2. Have a current CMV infection that is considered resistant or refractory due to inadequate adherence to prior oral anti-CMV treatment. 3. Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the time of enrollment. 4. Have severe hepatic impairment. 5. Require mechanical ventilation or vasopressors for hemodynamic support at the time of enrollment. 6. Have expected survival less than 6 weeks. 7. Be pregnant or breastfeeding. 8. Other clinically significant medical or surgical condition.

UCLA Medical Center, Los Angeles, California 90095, United States

Stanford University Medical Center, Stanford, California 94305, United States

University of Colorado, Denver, Colorado 80045, United States

Yale University, New Haven, Connecticut 06520, United States

University of Florida, Gainsville, Florida 32610, United States

Tampa General Hospital, Tampa, Florida 33614, United States

Emory University, Atlanta, Georgia 30322, United States

Northwestern University Medical Center, Chicago, Illinois 60611, United States

University of Chicago, Chicago, Illinois 60637, United States

Ochsner Clinic Foundation, New Orleans, Louisiana 70121, United States

Johns Hopkins Hospital, Baltimore, Maryland 21205, United States

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States

University of Massachusetts, Worcester, Massachusetts 01655, United States

University of Michigan, Ann Arbor, Michigan 48109, United States

Henry Ford Health Care System, Detroit, Michigan 48202, United States

University of Minnesota Medical Center, Minneapolis, Minnesota 55454, United States

University of Nebraska, Omaha, Nebraska 68198, United States

Columbia University, New York, New York 10032, United States

Memorial Sloan-Kettering Cancer Center, New York, New York 10065, United States

Duke University Medical Center, Durham, North Carolina 30322, United States

Wake Forest Medical Center, Winston Salem, North Carolina 27157, United States

Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States

Nationwide Children's Hospital, Columbus, Ohio 43205, United States

Albert Einstein Medical Center, Philadelphia, Pennsylvania 19141, United States

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

University of Pittsburg, Pittsburg, Pennsylvania 15213, United States

Medical University of South Carolina, Charleston, South Carolina 29425, United States

Vanderbilt Medical Center, Nashville, Tennessee 37212, United States

Methodist Healthcare System, San Antonio, Texas 78229, United States

University of Utah, Salt Lake City, Utah 84132, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington 98195, United States

University of Washington, Seattle, Washington 98109, United States

Starting date: July 2012
Last updated: March 9, 2015