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JC Virus Reactivation in Multiple Sclerosis

Information source: Beth Israel Deaconess Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Progressive Multifocal Leukoencephalopathy; Multiple Sclerosis

Phase: N/A

Status: Active, not recruiting

Sponsored by: Beth Israel Deaconess Medical Center

Official(s) and/or principal investigator(s):
Igor J Koralnik, MD, Principal Investigator, Affiliation: Beth Israel Deaconess Medical Center


JC virus is a benign virus which infects approximately up to 90% of the normal adult population. However, it may be reactivated in people who have a decreased immune function as in HIV infection, cancer, chemotherapy, transplant recipients, or in MS patients treated with natalizumab (Tysabri). In these patients, JC virus can cause a severe brain disease called Progressive Multifocal Leukoencephalopathy (PML), for which there is no cure. As of September 2013, 400 MS patients in the world, who have been treated with natalizumab, have developed PML. The risk of PML is approximately 5 patients in 1000 after 24 months on the drug. Researchers do not know exactly in which cells of the body the virus lives but it has been isolated from the blood, urine, cerebrospinal fluid (CSF), and from the brains of patients with immunosuppression. In this study, the investigators wish to determine precisely where the virus lives, and how the body prevents it from causing brain disease. Because of the association of PML with natalizumab, the investigators would like to see if there is a difference in the amounts of virus in blood, urine, and CSF found in MS patients treated with natalizumab or those treated with different medications for MS, or those not treated at all. The investigators hope that this knowledge will allow us to find better ways of preventing the development of PML as well as treatments for patients with PML.

Clinical Details

Official title: JC Virus Reactivation in Multiple Sclerosis

Study design: Observational Model: Case Control, Time Perspective: Cross-Sectional

Primary outcome: Molecular determinants of JCV reactivation in blood, urine, and CSF

Secondary outcome: Humoral and Cellular Immune Response to JCV

Detailed description: Subjects selected for participation in this study have been diagnosed with Multiple Sclerosis (MS). Of the MS patients enrolled in the study, some have been treated with natalizumab or a different medication for MS, and others have not been treated at all. All MS patients enrolled have their blood tested for the presence of the JC virus. Those testing negative for the JC virus do not continue in the study. Those testing positive for the JC virus continue participating in the study, and provide a urine sample, blood sample, lumbar puncture, and a neurological exam. Approximately 65 people will take part in this study at Beth Israel Deaconess Medical Center.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Clinical diagnosis of Multiple Sclerosis, relapsing remitting

Exclusion Criteria:

- JCV sero-negative

Locations and Contacts

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02115, United States
Additional Information

Starting date: October 2010
Last updated: December 4, 2013

Page last updated: August 23, 2015

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