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

  Show 37 Study Locations
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:
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014