JC Virus Reactivation in Multiple Sclerosis

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.

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Key information

Conditions

Progressive Multifocal Leukoencephalopathy Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases DNA Virus Infections Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Encephalitis Encephalitis, Viral Immune System Diseases Infections Infectious Encephalitis Leukoencephalopathies Leukoencephalopathy, Progressive Multifocal Multiple Sclerosis Nervous System Diseases Neuroinflammatory Diseases Polyomavirus Infections Slow Virus Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of Multiple Sclerosis, relapsing remitting

Exclusion criteria

JCV sero-negative

Treatment and study plan

Primary outcomes

Molecular determinants of JCV reactivation in blood, urine, and CSF

Time frame: 1 day

Characterize the phenotype of the cells carrying JCV in the blood of MS patients after 18, 24 and 36 months on continuous natalizumab therapy and in interferon-beta treated and untreated MS subjects, and analyze the molecular determinants of JCV reactivation in their blood, urine and CSF.

Secondary outcomes

Humoral and Cellular Immune Response to JCV

Time frame: 1 day

Evaluate the humoral and cellular immune response against JCV in MS patients after 18, 24 and 36 months on continuous natalizumab therapy and in interferon-beta treated and untreated MS subjects, and correlate these findings with JCV reactivation in different compartments.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

Biogen
National Multiple Sclerosis Society

Registry information

Acronym: JCV in MS

Important dates

Study start: 2010
Primary completion: 2016
Study completion: 2016
First posted: Dec 9, 2013
Registry last updated: Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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