JC Virus Expression in Urine and Blood

Brief Description Of Study

The purpose of this study is to determine if JCV antibody levels in the blood correlate with the presence of virus levels in the urine. Individuals with MS will be asked to provide urine samples collected daily and stored at home for 30 consecutive days. We will ask patients to do this twice separated by 6 months. JCV blood tests with antibody titers will also be performed for each collection period.

Clinical Study Identifier: TX1067

Detailed Study Description

This study is titled, "Dynamic Expression of JC Virus in the Urine and its Relationship to JCV Serostatus" and the purpose is to determine if JCV antibody titers correlate with viral expression in the urine by: 1) Determining the day to day variation in JCV shedding in the urine 2) Determining whether the persistence of JCV viruria correlates with JCV antibody serostatus, and 3) Determine whether the quantity of JCV shed in urine correlates with JCV antibody titer. This case-control longitudinal study will be conducted with participants recruited at the University of Pennsylvania. Individuals will have urine specimens collected daily for 30 consecutive days at two intervals separated by 6 months. JCV serological status with antibody titers will be determined at the onset and the conclusion of each collection period. This study will represent the most extensive and precise examination of JCV shedding in urine to date. Thirty patients who have MS and are receiving natalizumab (tysabri) and 30 MS patients on other disease modifying drugs will be enrolled. Participants must be 18 years of age and older.

Additional Information About The Study

The information collected in this study may help researchers and health care professionals better understand the JC Virus and risk factors for developing progressive multifocal encephalopathy (PML).

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