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

This study is ongoing, but not recruiting participants.

Sponsored by:	National Center for Research Resources (NCRR)
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00004573

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

MedlinePlus related topics: Cytomegalovirus Infections

Drug Information available for: Ganciclovir Ganciclovir sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic

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

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

National Center for Research Resources (NCRR)

More Information

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

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

cytomegalovirus viremia

Study placed in the following topic categories:

Virus Diseases
Cytomegalovirus Infections
Ganciclovir
DNA Virus Infections

Viremia
Cytomegalic inclusion disease
Cytomegalovirus
Herpesviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009