Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2025-12-26 @ 6:52 AM
Study NCT ID:
NCT00032695
Status:
COMPLETED
Last Update Posted:
2006-05-15
First Post:
2002-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of AIDS Vacuolar Myelopathy With Methionine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008715', 'term': 'Methionine'}], 'ancestors': [{'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-11', 'lastUpdateSubmitDate': '2006-05-12', 'studyFirstSubmitDate': '2002-03-28', 'studyFirstSubmitQcDate': '2002-03-28', 'lastUpdatePostDateStruct': {'date': '2006-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-03-29', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['myelopathy', 'AIDS-myelopathy', 'AIDS vacuolar myelopathy', 'methionine'], 'conditions': ['Myelopathy', 'AIDS-Myelopathy', 'AIDS Vacuolar Myelopathy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Between 18 and 80 years of age'}, 'identificationModule': {'nctId': 'NCT00032695', 'briefTitle': 'Treatment of AIDS Vacuolar Myelopathy With Methionine', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Neurological Disorders and Stroke (NINDS)'}, 'orgStudyIdInfo': {'id': 'R01NS035745', 'link': 'https://reporter.nih.gov/quickSearch/R01NS035745', 'type': 'NIH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'methionine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Beth Israel Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Alessandro Di Rocco, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}}}}