Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-29 @ 9:18 AM
Study NCT ID:
NCT01828268
Status:
UNKNOWN
Last Update Posted:
2017-04-28
First Post:
2013-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolomics Fingerprinting and Metabolic Dynamics After HIV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma from peripheral blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-26', 'studyFirstSubmitDate': '2013-04-05', 'studyFirstSubmitQcDate': '2013-04-09', 'lastUpdatePostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dyslipidemia', 'timeFrame': 'Dyslipidemia events from admission to discharge(Up to 6 months) )'}], 'secondaryOutcomes': [{'measure': 'Lipoatrophy', 'timeFrame': 'Lipoarophy events from admission to discharge (up to 6 months)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'Metabolomics Fingerprinting'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '17879926', 'type': 'BACKGROUND', 'citation': 'Schackman BR, Scott CA, Sax PE, Losina E, Wilkin TJ, McKinnon JE, Swindells S, Weinstein MC, Freedberg KA. Potential risks and benefits of HIV treatment simplification: a simulation model of a proposed clinical trial. Clin Infect Dis. 2007 Oct 15;45(8):1062-70. doi: 10.1086/521933. Epub 2007 Sep 4.'}, {'pmid': '12461419', 'type': 'BACKGROUND', 'citation': 'Joly V, Flandre P, Meiffredy V, Leturque N, Harel M, Aboulker JP, Yeni P. Increased risk of lipoatrophy under stavudine in HIV-1-infected patients: results of a substudy from a comparative trial. AIDS. 2002 Dec 6;16(18):2447-54. doi: 10.1097/00002030-200212060-00010.'}, {'pmid': '12792352', 'type': 'BACKGROUND', 'citation': 'John M, McKinnon EJ, James IR, Nolan DA, Herrmann SE, Moore CB, White AJ, Mallal SA. Randomized, controlled, 48-week study of switching stavudine and/or protease inhibitors to combivir/abacavir to prevent or reverse lipoatrophy in HIV-infected patients. J Acquir Immune Defic Syndr. 2003 May 1;33(1):29-33. doi: 10.1097/00126334-200305010-00005.'}, {'pmid': '19687491', 'type': 'BACKGROUND', 'citation': 'Zhang F, Dou Z, Ma Y, Zhao Y, Liu Z, Bulterys M, Chen RY. Five-year outcomes of the China National Free Antiretroviral Treatment Program. Ann Intern Med. 2009 Aug 18;151(4):241-51, W-52. doi: 10.7326/0003-4819-151-4-200908180-00006.'}, {'pmid': '19451751', 'type': 'BACKGROUND', 'citation': 'Zyromski NJ, Mathur A, Gowda GA, Murphy C, Swartz-Basile DA, Wade TE, Pitt HA, Raftery D. Nuclear magnetic resonance spectroscopy-based metabolomics of the fatty pancreas: implicating fat in pancreatic pathology. Pancreatology. 2009;9(4):410-9. doi: 10.1159/000199436. Epub 2009 May 19.'}, {'pmid': '12819520', 'type': 'RESULT', 'citation': "Friis-Moller N, Weber R, Reiss P, Thiebaut R, Kirk O, d'Arminio Monforte A, Pradier C, Morfeldt L, Mateu S, Law M, El-Sadr W, De Wit S, Sabin CA, Phillips AN, Lundgren JD; DAD study group. Cardiovascular disease risk factors in HIV patients--association with antiretroviral therapy. Results from the DAD study. AIDS. 2003 May 23;17(8):1179-93. doi: 10.1097/01.aids.0000060358.78202.c1."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this plot study is to find out the relationship between metabolic changes and anti-retroviral therapy (ART), life style and clinical conditions of HIV-infected patients using nuclear magnetic resonance (NMR) based systems biology approach and metabolomics methodology.', 'detailedDescription': "Since the clinical application of anti-retroviral therapy (ART) in 1997, the life expectancy of HIV infected patients has been prolonged greatly. However,side effects of ART including metabolic abnormalities have become the main factors influencing patients' quality of life. Among which the abnormal lipid metabolism plays an important role. Meanwhile, metabolic conditions differ from patients applying to different combinations of ART drugs,life style and clinical conditions.\n\nMetabolomics can measure the dynamic metabolic responses of the body to stimuli or modifications. Using nuclear magnetic resonance (NMR) as tools can systematically analyse the process of lipid metabolism. Metabolomics fingerprinting can be defined as the complete complement of small molecule (\\< 1500 Da) metabolites found in a specific cell, body fluid, organ or organism.\n\nTherefore, the study of the impact of metabolic changes and anti-retroviral therapy (ART), life style and clinical conditions is of importance in enhancing the adherence and improving the clinical outcomes of HIV infected patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Recruit 100 HIV-infected individuals from community HIV Clinic and/or Transmitted Disease Hospital of Chengdu', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of HIV infection\n\nExclusion Criteria:\n\n* Pregnancy\n* Individual who is participating in other trial(s)'}, 'identificationModule': {'nctId': 'NCT01828268', 'briefTitle': 'Metabolomics Fingerprinting and Metabolic Dynamics After HIV Infection', 'organization': {'class': 'OTHER', 'fullName': 'Sichuan Academy of Medical Sciences'}, 'officialTitle': 'Metabolic Fingerprintings and Metabolic Dynamics After HIV Infection:Impact of Metabolic Changes and Anti-Retroviral Therapy, Life Style and Clinical Conditions', 'orgStudyIdInfo': {'id': 'META-HA-001-2013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV infectors', 'description': '100 confirmed HIV-1 infected patients who meet inclusion criteria.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '610101', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hua JIANG, PhD', 'role': 'CONTACT', 'email': 'hua.jiang@truamabank.org', 'phone': '+86-28-88424391'}, {'name': 'Jin PENG, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sichuan Academy of Medical Sciences,Sichuan Provincial Hospital, Metabolomics and Mutidisciplinary Laboratory', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Hua JIANG, PhD', 'role': 'CONTACT', 'email': 'hua.jiang@traumabank.org', 'phone': '+86-28-88424391'}, {'name': 'Bing CAI, Master', 'role': 'CONTACT', 'phone': '+86-28-88424391'}], 'overallOfficials': [{'name': 'Hua JIANG, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "3Sichuan Academy of Medical Science, Sichuan Provincial People's Hospital, East Branch, Metabonomics and Multidisciplinary Laboratory"}, {'name': 'Jin PENG, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "3Sichuan Academy of Medical Science, Sichuan Provincial People's Hospital, East Branch, Metabonomics and Multidisciplinary Laboratory"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sichuan Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}