Treatment of AIDS Vacuolar Myelopathy With Methionine - Tabular View

Tracking Information

First Received Date ^ICMJE

March 28, 2002

Last Updated Date

May 12, 2006

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00032695 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Treatment of AIDS Vacuolar Myelopathy With Methionine

Official Title ^ICMJE

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control

Condition ^ICMJE

Myelopathy
AIDS-Myelopathy
AIDS Vacuolar Myelopathy

Intervention ^ICMJE

Drug: methionine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Between 18 and 80 years of age

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00032695

Responsible Party

Study ID Numbers ^ICMJE

R01NS35745

Study Sponsor ^ICMJE

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Alessandro Di Rocco, MD

Information Provided By

National Institute of Neurological Disorders and Stroke (NINDS)

Verification Date

November 2005

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