NCT00342602

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
Last Updated

March 17, 2009

Status Verified

June 1, 2006

First QC Date

June 19, 2006

Last Update Submit

March 16, 2009

Conditions

Keywords

JC VirusOpportunistic InfectionSingle Nucleotide PolymorphismGenotypeSequencing

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* No available subjects will be excluded.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Howard Brown Health Center

Chicago, Illinois, 60613, United States

Location

Johns Hopskins Hospital

Baltimore, Maryland, 21205, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (1)

  • 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. doi: 10.7326/0003-4819-107-1-78.

    PMID: 3296901BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeOpportunistic Infections

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

August 1, 2005

Last Updated

March 17, 2009

Record last verified: 2006-06

Locations