Genetics of Progressive Multifocal Leukoencephalopathy and Acquired Immunodeficiency Syndrome

This study has been completed.
Sponsor:
Collaborator:
Multicenter AIDS Cohort Study (MACS)
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00342602
First received: June 19, 2006
Last updated: March 16, 2009
Last verified: June 2006

June 19, 2006
March 16, 2009
August 2005
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Complete list of historical versions of study NCT00342602 on ClinicalTrials.gov Archive Site
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Genetics of Progressive Multifocal Leukoencephalopathy and Acquired Immunodeficiency Syndrome
Influence of Host Genetic Factors in Development of PML in an AIDS Cohort

This study will identify genetic factors associated with the development of progressive multifocal leukoencephalopathy (PML) in patients with acquired immunodeficiency syndrome (AIDS). PML is a life-threatening infection of the brain that affects about 5 percent of untreated patients with AIDS. Its symptoms include mental deterioration, vision loss, speech disturbances, ataxia (inability to coordinate movements), paralysis, and coma. PML is caused by a polyomavirus called the JC virus.

It is estimated that up to 80 percent of the human population has been exposed to the JC virus, but the disease is very rare. The virus only becomes active in people who have compromised immune systems, such as those undergoing immune suppressive chemotherapy for cancer and those with damaged immune systems due to HIV.

Patients who have participated in the Multicenter AIDS Cohort Study may be eligible for this study, as well as healthy normal volunteers who will serve as controls. The study will review clinical information from patients and analyze genetic factors from both patients and control subjects to investigate genes associated with AIDS and JC virus infection.

The purpose of this study is to identify host genetic factors that contribute to the development of Progressive Multifocal Leukoencephalopathy (PML) associated with JC virus. JC virus is one of many opportunistic infections that arise in AIDS patients. JC virus is widely distributed in the general population, with estimates of population exposure ranging from 30-80%. JC virus remains latent in the host, and in profoundly immunosuppressed patients, JC virus can cause PML, a fatal disease associated with neurotropic JC virus that lytically infects oligodendrocytes. In untreated AIDS populations, the frequency of PML has been estimated at roughly 5%. This study will identify host genetic factors that may contribute to the development of PML in the AIDS population.

Observational
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  • PML
  • AIDS
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Berger JR, Kaszovitz B, Post MJ, Dickinson G. Progressive multifocal leukoencephalopathy associated with human immunodeficiency virus infection. A review of the literature with a report of sixteen cases. Ann Intern Med. 1987 Jul;107(1):78-87. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
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  • No available subjects will be excluded.
Both
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Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00342602
999905218, 05-C-N218
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National Cancer Institute (NCI)
Multicenter AIDS Cohort Study (MACS)
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National Institutes of Health Clinical Center (CC)
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP