Treatment of AIDS Vacuolar Myelopathy With Methionine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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Myelopathy AIDS-Myelopathy AIDS Vacuolar Myelopathy

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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methionine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Between 18 and 80 years of age

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Alessandro Di Rocco, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Beth Israel Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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R01NS035745

Identifier Type: NIH

Identifier Source: org_study_id

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