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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. The completion date has passed and the status has not been verified in more than two years.
Verified November 2001 by National Center for Research Resources (NCRR).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004573
First Posted: February 21, 2000
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Center for Research Resources (NCRR)
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004573


Locations
United States, Missouri
Infectious Diseases Division
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
National Center for Research Resources (NCRR)
  More Information

ClinicalTrials.gov Identifier: NCT00004573     History of Changes
Other Study ID Numbers: NCRR-M01RR00036-0728
M01RR000036 ( U.S. NIH Grant/Contract )
First Submitted: February 18, 2000
First Posted: February 21, 2000
Last Update Posted: December 9, 2005
Last Verified: November 2001

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

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Ganciclovir
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action