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Subjects with symptomatic CMV infection, who are enrolled in this clinical study, will be monitored during antiviral therapy. The study will be conducted in two phases. The Pilot Phase will be used to make an initial estimate of the kinetics of the change in viral load over time observed with the artus® CMV RG PCR test that indicates: (a) response to antiviral therapy ("Medical Decision Point #1"), and (b) successful antiviral therapy ("Medical Decision Point #2") in the adult kidney transplant population as defined by the CMV-LDT test. Data generated in the Pilot Phase will be used to set statistical requirements for the Pivotal Phase of the clinical study wherein these indications will be verified.
The human Cytomegalovirus (CMV) is found in blood, tissues and nearly all secretory fluids of infected persons. Transmission can be oral, sexual, via blood transfusion, organ transplantation, intrauterine, or perinatal. Infection with CMV preadolescence frequently leads to an asymptomatic infection followed by a lifelong persistence of the virus in the body. Infection post adolescence typically leads to symptoms that resemble those of mononucleosis (e.g., fever, fatigue, hepatitis, etc.) In contrast, CMV infections in immune compromised patients can be life threatening. A major cause of virus-associated morbidity and mortality in solid organ transplantation patients is illness caused by CMV (i.e., CMV syndrome or CMV disease).
The risk of progressing to CMV disease post-transplant is strongly correlated with the serological status of the donor (D) and recipient (R); the highest risk group is R-/D+. Patients at risk for CMV disease can be managed either preemptively (i.e., patients are only treated with antiviral agents after evidence of CMV infection arises), or prophylactically (i.e., all patients are treated with antiviral agents regardless of CMV infection status). Monitoring of the CMV viral load of transplant patients during antiviral therapy provides an effective aid in the management of patients with CMV disease. The artus® CMV RG PCR test is a nucleic acid amplification-based assay for the quantitation of CMV DNA using PCR in the Rotor-Gene™ 6000 Instrument (also known as Rotor-Gene Q) with software version 18.104.22.168 or higher. In the present study the artus CMV RG PCR test result will be evaluated for its ability to safely and effectively monitor transplant patients during antiviral therapy.
Observational Model: Cohort, Time Perspective: Prospective
University of California - Los Angeles
QIAGEN Gaithersburg, Inc
Published on BioPortfolio: 2014-08-27T03:17:11-0400
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