Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-25 @ 4:52 PM
Study NCT ID:
NCT00244803
Status:
COMPLETED
Last Update Posted:
2016-08-31
First Post:
2005-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Redistribution of Fat and Metabolic Change in HIV Infection: Protocol 2 (FRAM Fat 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-30', 'studyFirstSubmitDate': '2005-10-25', 'studyFirstSubmitQcDate': '2005-10-25', 'lastUpdatePostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Human Immunodeficiency Virus', 'FRAM 1'], 'conditions': ['Human Immunodeficiency Virus']}, 'referencesModule': {'references': [{'pmid': '21767228', 'type': 'DERIVED', 'citation': 'Lake JE, Wohl D, Scherzer R, Grunfeld C, Tien PC, Sidney S, Currier JS. Regional fat deposition and cardiovascular risk in HIV infection: the FRAM study. AIDS Care. 2011 Aug;23(8):929-38. doi: 10.1080/09540121.2010.543885. Epub 2011 Jun 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn whether HIV-infected patients have blood abnormalities which could lead to heart attack or stroke, and to find out what factors may contribute to these abnormalities.', 'detailedDescription': 'This research is being done to learn whether HIV-infected patients have abnormalities in their blood vessels that could eventually lead to heart attack or stroke (atherosclerosis), in how fat is distributed in their body and in how their body handles fat and sugars. If there are abnormalities, this study will also try to find out what factors may contribute to those abnormalitites.\n\nPeople who participated in FRAM 1 may join FRAM 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'men or women 18-65 years old, previous FRAM 1 participant, HIV positive', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years old\n* previous FRAM 1 participant\n* HIV positive\n\nExclusion Criteria:\n\n* Artificial knee or hip replacement or Harrington rod\n* Metal objects in the body.Pregnancy\n* Breastfeeding or less than 3 months after breastfeeding\n* Weight more than 300 pound\n* On insulin, pancreatic enzymes, or thioridazine.'}, 'identificationModule': {'nctId': 'NCT00244803', 'briefTitle': 'Redistribution of Fat and Metabolic Change in HIV Infection: Protocol 2 (FRAM Fat 2)', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Redistribution and Metabolic Change in HIV Infection: Protocol 2 (FRAM Fat 2)', 'orgStudyIdInfo': {'id': '03-07-02-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV Positive FRAM 1 Participant'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University, The Clinical Trials Unit', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Joseph Cofrancesco Jr., M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}