Back to resultsTreatment of AIDS Vacuolar Myelopathy With Methionine
Primary Purpose
Myelopathy, AIDS-Myelopathy, AIDS Vacuolar Myelopathy
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
methionine
Sponsored by
About this trial
This is an interventional treatment trial for Myelopathy focused on measuring myelopathy, AIDS-myelopathy, AIDS vacuolar myelopathy, methionine
Eligibility Criteria
Between 18 and 80 years of age
Sites / Locations
- Beth Israel Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00032695
First Posted
March 28, 2002
Last Updated
May 12, 2006
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT00032695
Brief Title
Treatment of AIDS Vacuolar Myelopathy With Methionine
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether methionine, an amino acid present in low doses in the normal diet, can improve myelopathy or stop its progression.
Detailed Description
Myelopathy is usually a late complication of AIDS, and until recently its symptoms were rarely recognized, masked by the general state of disability or the presence of other neurological complications. With prolonged survival and improved quality of life of HIV-infected patients, myelopathy is increasingly becoming a common source of disability. The cause of AIDS-myelopathy is unknown, but it is probably an indirect effect of the long-term presence of the HIV virus in the nervous system rather than the result of a direct infection. The purpose of this study is to determine whether methionine, an amino acid present in low doses in the normal diet, can improve myelopathy or stop its progression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelopathy, AIDS-Myelopathy, AIDS Vacuolar Myelopathy
Keywords
myelopathy, AIDS-myelopathy, AIDS vacuolar myelopathy, methionine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
56 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
methionine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Between 18 and 80 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Di Rocco, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of AIDS Vacuolar Myelopathy With Methionine
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