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Kinetics of Response of Cytomegalovirus With Ganciclovir Treatment Using Quantitative Real-Time PCR

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2001 by National Center for Research Resources (NCRR).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00004573
First received: February 18, 2000
Last updated: June 23, 2005
Last verified: November 2001
  Purpose

The overall purpose of this research is to develop and use a blood test to better understand how quickly the viral drug ganciclovir works to clear infection with the CMV virus (Cytomegalovirus) when it occurs. This test will potentially let doctors know early in the course of therapy when a virus is not responding well to the therapy and could therefore be resistant to the drug. The target population of this study will be primarily kidney and lung transplant patients with CMV detected in the blood, although other patients may also be included if they meet criteria. The study will be divided into two phases. Phase I will evaluate a small number of exploratory patients initiating ganciclovir therapy and will require frequent blood sampling to obtain detailed information regarding the kinetic response of the virus to therapy. This information will be analyzed to help guide decisions regarding the number and frequency of blood samples needed in the larger phase II portion of the study. Strains will be characterized using phenotypic and genotypic methods to determine the presence or absence of mutations potentially responsible for the resistance.


Condition Intervention
Cytomegalovirus Infections
Drug: ganciclovir

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients affiliated with Barnes-Jewish Hospital with CMV blood infection requiring antiviral therapy
  • All patients will have a positive qualitative CMV PCR or viral culture before starting therapy
  • Patients will receive treatment with ganciclovir at a dose and duration to be determined by the provider
  • It is anticipated that most subjects will be organ transplant recipients but this is not a requirement of the study

Exclusion Criteria:

  • Critically ill patients
  • Patients with profound leukopenia or abnormal renal function that make a change in the antiviral drug dosage likely during the duration of the study
  • Anemia (HGB < 8 g/dl) that would contraindicate the extra blood draws required by this study
  • Problems with vascular access that would interfere with obtaining blood samples required by this study
  • Residence outside of the St. Louis metropolitan area during the period of ganciclovir therapy
  • Patients who are unable to provide informed consent because of diminished capacity related to illness, dementia, or other reasons
  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: NCT00004573

Locations
United States, Missouri
Infectious Diseases Division
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004573     History of Changes
Other Study ID Numbers: NCRR-M01RR00036-0728, M01RR00036
Study First Received: February 18, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):
cytomegalovirus viremia

Additional relevant MeSH terms:
Cytomegalovirus Infections
DNA Virus Infections
Herpesviridae Infections
Virus Diseases
Ganciclovir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014