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

Tracking Information
First Received Date ^ICMJE	February 18, 2000
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00004573 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Kinetics of Response of Cytomegalovirus With Ganciclovir Treatment Using Quantitative Real-Time PCR
Official Title ^ICMJE
Brief Summary	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.
Detailed Description
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Diagnostic
Condition ^ICMJE	Cytomegalovirus Infections
Intervention ^ICMJE	Drug: ganciclovir
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00004573
Responsible Party
Study ID Numbers ^ICMJE	NCRR-M01RR00036-0728, M01RR00036
Study Sponsor ^ICMJE	National Center for Research Resources (NCRR)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Center for Research Resources (NCRR)
Verification Date	November 2001
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP