A Multicenter, Open-label Study of CMX001 Treatment of Serious Diseases or Conditions Caused by dsDNA Viruses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chimerix
ClinicalTrials.gov Identifier:
NCT01143181
First received: June 11, 2010
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

CMX001 is an orally administered lipid conjugate of the synthetic nucleotide analog cidofovir (CDV). The conjugate is believed to be absorbed in the small intestine then delivered to target organs throughout the body where it crosses cell membranes by facilitated and passive diffusion. Inside the cell, CMX001 is cleaved by intracellular phospholipases to release CDV which is converted to the active antiviral agent, CDV-diphosphate (CDV-PP), by intracellular anabolic kinases. Adults and adolescents, regardless of viral infection/disease, will have a maximum weekly dose of 200 mg i.e., 200 mg once weekly OR 100 mg twice weekly; not to exceed 4mg/kg total weekly dose. Pediatric subjects (< 12 years), regardless of viral infection/disease, will have a maximum weekly dose of 4 mg/kg i.e., 4 mg/kg once weekly OR 2 mg/kg twice weekly.


Condition Intervention Phase
Male or Female Patients With a Serious or Immediately Life-threatening
Disease or Condition Caused by CMV, ADV, HSV, VAVC, VARV or
Monkeypox Viruses(s) Who Have a Life Expectancy of ≥ 2 Weeks and for
Whom no Comparable or Satisfactory Alternative Therapy is Available
Drug: CMX001
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label Study of CMX001 Treatment of Serious Diseases or Conditions Caused by dsDNA Viruses

Resource links provided by NLM:


Further study details as provided by Chimerix:

Enrollment: 232
Study Start Date: December 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: CMX001
    CMX001 administered orally twice weekly for up to 3 months. Treatment may be extended for up to 6 months depending on the patient's clinical response.
    Other Name: CMX001
  Eligibility

Ages Eligible for Study:   1 Month and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with an immediately life-threatening or serious disease or condition caused by CMV, ADV, HSV, VAVC, VARV or monkeypox viruses(s).
  2. Life expectancy of at least 2 weeks and commitment to continuation of supportive care for at least 4 weeks.
  3. Able to ingest and absorb oral medication (in the judgment of the investigator and based on lack of significant GI pathology such as small bowel resection or ileus). [Note: Use of TPN (total parenteral nutrition) is not in and of itself exclusionary as long as the reason for use would not disqualify the patient based on this criterion.]
  4. Willing and able to understand and provide written informed consent. For minors or those incapable of providing written informed consent (i.e., incapacitated), understood, written and informed consent must be provided by a parent or legal guardian or representative.
  5. To the best of his or her (or parent/guardian) knowledge, willing and able to participate in all required study activities for the duration of the study.
  6. In the judgment of the investigator, patients for whom no comparable or satisfactory therapeutic alternative is available

Exclusion Criteria:

  1. Females who are pregnant or currently nursing.
  2. Patients with hypersensitivity to cidofovir or CMX001.
  3. Patients whose long-term prognosis includes a poor likelihood of survival due to irreversible organ failure including, for example, patients with frank hepatic failure and adults with Grade 4 GVHD of the GI tract.
  4. Patients who are eligible for enrollment and able to participate in a clinical trial evaluating CMX001.
  5. Patients with any other condition that would, in the judgment of the investigator, put the patient at increased risk during participation in the study, or interfere with the conduct of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01143181

  Hide Study Locations
Locations
United States, California
Loma Linda University Hospital
Loma Linda, California, United States, 92354
Children's Hospital of LA
Los Angeles, California, United States, 90027
UCLA Department of Medicine
Los Angeles, California, United States, 90095
CHOC Children's
Orange, California, United States, 92868
Univeristy of San Francisco
San Francisco, California, United States, 94143
Lucile Packard Children's Hospital
Stanford, California, United States, 94304
United States, Colorado
Children's Hospital of Colorado
Aurora, Colorado, United States, 80045
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Louisiana
Childrens Hospital LSU
New Orleans, Louisiana, United States, 70118
United States, Maryland
NIH
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
St. Louis Children's Hospital
St. Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-5130
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Memorial Sloan Kettering Cancer Institute
New York, New York, United States, 10065
Mt. Sinai
New York, New York, United States, 10029
Columbia University
New York, New York, United States, 10032
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Levine Children's Hospital Carolina Medical Center
Charlotte, North Carolina, United States, 28203
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati Childrens Hospital
Cincinnati, Ohio, United States, 45229
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
UPMC
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104-2796
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Intermountain BMT program LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Washington
University of Washington-Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Chimerix
  More Information

No publications provided

Responsible Party: Chimerix
ClinicalTrials.gov Identifier: NCT01143181     History of Changes
Other Study ID Numbers: CMX001-350
Study First Received: June 11, 2010
Last Updated: August 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Chimerix:
CMV, ADV, HSV, VAVC, VARV
life threatening

Additional relevant MeSH terms:
Virus Diseases
Monkeypox
Poxviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on August 28, 2014