Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-02-10 @ 10:41 PM
Study NCT ID:
NCT03913351
Status:
UNKNOWN
Last Update Posted:
2023-08-30
First Post:
2019-04-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lifestyle Modification Programme for HIV-infected Individuals With Fatty Liver
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-28', 'studyFirstSubmitDate': '2019-04-09', 'studyFirstSubmitQcDate': '2019-04-10', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution of NAFLD', 'timeFrame': '12 months', 'description': 'The primary endpoint is the proportion of patients with resolution of NAFLD as determined by proton-magnetic resonance spectroscopy at month 12.'}], 'secondaryOutcomes': [{'measure': 'Partial resolution of NAFLD', 'timeFrame': '12 months', 'description': 'Partial resolution of NAFLD is defined as absolute reduction of hepatic triglyceride content by 30% or more.'}, {'measure': 'Changes in adiposity', 'timeFrame': '12 months', 'description': 'The changes in visceral fat will be determined by magnetic resonance imaging at the same session'}, {'measure': 'Change in liver fibrosis', 'timeFrame': '12 months', 'description': 'The changes in liver fibrosis will be determined by transient elastography by Fibroscan'}, {'measure': 'Metabolic endpoints', 'timeFrame': '12 months', 'description': 'The proportion of patients with impaired fasting glucose will be determined'}, {'measure': 'Metabolic endpoints', 'timeFrame': '12 months', 'description': 'The proportion of patients with diabetes will be determined'}, {'measure': 'Metabolic endpoints', 'timeFrame': '12 months', 'description': 'The proportion of patients with insulin resistance (estimated by the homeostasis model) will be determined'}, {'measure': 'Metabolic endpoints', 'timeFrame': '12 months', 'description': 'The proportion of patients with hypertension will be determined'}, {'measure': 'Metabolic endpoints', 'timeFrame': '12 months', 'description': 'The proportion of patients with dyslipidemia will be determined'}, {'measure': 'Metabolic endpoints', 'timeFrame': '12 months', 'description': 'The proportion of patients with metabolic syndrome will be determined'}, {'measure': 'Biomarkers of inflammation and monocyte activation', 'timeFrame': '12 months', 'description': 'Changes from baseline in adipokines (adiponectin and leptin)'}, {'measure': 'Biomarkers of inflammation and monocyte activation', 'timeFrame': '12 months', 'description': 'Changes from baseline in marker of endothelial cell activation (ICAM-1)'}, {'measure': 'Biomarkers of inflammation and monocyte activation', 'timeFrame': '12 months', 'description': 'Changes from baseline in marker of monocyte activation (sCD163)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NAFLD', 'Hiv']}, 'referencesModule': {'references': [{'pmid': '40347962', 'type': 'DERIVED', 'citation': 'Li G, Wong VW, Chan RS, Sin DM, Chu W, Wong V, Cheung C, Lam S, Lin H, Yeung S, Li TC, Ho TH, Wong GL, Yip TC, Lui GC. Lifestyle modification programme for people living with HIV with metabolic dysfunction-associated steatotic liver disease: a randomised controlled trial. Lancet HIV. 2025 Jun;12(6):e416-e427. doi: 10.1016/S2352-3018(25)00032-3. Epub 2025 May 8.'}]}, 'descriptionModule': {'briefSummary': 'Non-alcoholic fatty liver disease (NAFLD) is rising in prevalence, and will likely become the predominant cause of chronic liver disease in HIV-infected individuals.\n\nMetabolic factors and obesity are important risk factors for NAFLD in HIV-infected individuals. There is currently no approved effective pharmacological treatment for fatty liver disease. Therefore, lifestyle modification directing at weight loss is currently the cornerstone of treatment for fatty liver disease in the general population. Hypocaloric diets can improve fatty liver in the general population, but the most effective specific dietary interventions are yet to be elucidated.\n\nThe study aims to 1. determine the efficacy of a lifestyle modification programme in inducing resolution of NAFLD in HIV-infected individuals 2. to determine the efficacy of a lifestyle modification programme in improving insulin resistance, pro-inflammatory markers, and liver fibrosis in HIV-infected individuals with fatty liver disease 3. to determine changes in intestinal microbiome secondary to the lifestyle modification programme, and the association with resolution of NAFLD in this group of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 years or above\n* positive HIV antibody, on anti-retroviral therapy\n* HIV viral load ≤50 copies/mL for ≥6 months\n* intrahepatic triglyceride content ≥5% on magnetic resonance spectroscopy\n\nExclusion Criteria:\n\n* current AIDS-defining illness\n* active malignancy, or history of malignancy within the last 5 years\n* hepatitis B and/or hepatitis C co-infection, as determined by positive HBsAg and anti--HCV antibody\n* alcohol consumption \\>30g per week in men or 20g per week in women\n* alanine aminotransferase (ALT) above 10 times the upper limit of normal\n* liver decompensation (as evidenced by bilirubin above 50 µmol/l, platelet count below 100 × 109/l, prothrombin time above 1.3 times the upper limit of normal, albumin below 35 g/l, presence of ascites or varices).'}, 'identificationModule': {'nctId': 'NCT03913351', 'briefTitle': 'Lifestyle Modification Programme for HIV-infected Individuals With Fatty Liver', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Lifestyle Modification Programme for HIV-infected Individuals With Non-alcoholic Fatty Liver Disease: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Study Protocol LSM V2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle modification program', 'description': 'The dietary intervention program will be scheduled for 12 months, and conducted by a dietitian.The program aims to increase energy expenditure and reduce caloric intake, with an emphasis on long-term lifestyle and behavioural change. An exercise instructor will provide advice on physical activity. A mobile tracking device to monitor calories expenditure will be provided to each participant during they study period to encourage physical activity.', 'interventionNames': ['Behavioral: Lifestyle modification']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'standard care of treatment, as in routine clinical practice'}], 'interventions': [{'name': 'Lifestyle modification', 'type': 'BEHAVIORAL', 'description': 'The program consists of education on glycemic index, balanced diet, interpretation of food labels, food exchanges, healthy eating out techniques and healthy cooking methods.', 'armGroupLabels': ['Lifestyle modification program']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shatin', 'status': 'RECRUITING', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}], 'centralContacts': [{'name': 'Vivian Wong', 'role': 'CONTACT', 'email': 'vivianwong@cuhk.edu.hk', 'phone': '+85259621224'}, {'name': 'Grace Lui', 'role': 'CONTACT', 'email': 'gracelui@cuhk.edu.hk', 'phone': '+85235051464'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Grace Lui', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}