Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT06317051
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2024-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimising Metabolic Management for People With Human Immunodeficiency Virus (HIV) on Integrase Based Antiretroviral Therapy (ART)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D015430', 'term': 'Weight Gain'}], 'ancestors': [{'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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}, {'id': 'C108475', 'term': 'pitavastatin'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D000069438', 'term': 'Ezetimibe'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2024-02-21', 'studyFirstSubmitQcDate': '2024-03-11', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the impact of dapagliflozin vs. placebo on weight reduction', 'timeFrame': '24 weeks', 'description': 'Mean reduction change in body weight across treatment arms at 24 weeks, defined as absolute body weight change.'}, {'measure': 'To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe on low-density lipoproteins (LDL) concentration', 'timeFrame': '24 weeks', 'description': 'Mean change in LDL as absolute change from baseline to 24 weeks across treatment arms'}], 'secondaryOutcomes': [{'measure': 'To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on body mass index (BMI )- weight and height will be combined to report BMI in kg/m^2', 'timeFrame': '48 weeks'}, {'measure': 'To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on waist (cm) to hip (cm) ratio', 'timeFrame': '48 weeks'}, {'measure': 'To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on waist (cm) to height (cm) ratio', 'timeFrame': '48 weeks'}, {'measure': 'To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on systolic and diastolic blood pressure (mm Hg)', 'timeFrame': '48 weeks'}, {'measure': "To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on Atherosclerotic cardiovascular disease risk score (ASCVD) - calculation of a person's10-year risk (%) of having a cardiovascular problem.", 'timeFrame': '48 weeks'}, {'measure': 'To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on fasting lipids including: Total Cholesterol (mmol/L), LDL (mmol/L), High-Density Lipoproteins (HDL) (mmol/L), Triglycerides (mmol/L)', 'timeFrame': '48 weeks'}, {'measure': 'To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on fasting glucose (mmol/L)', 'timeFrame': '48 weeks'}, {'measure': 'To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on haemoglobin A1C (%)', 'timeFrame': '48 weeks'}, {'measure': 'To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on measures of fatty liver disease: Liver Function Tests - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (U/L), FibroScan (kPa)', 'timeFrame': '48 weeks'}, {'measure': 'To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on inflammatory biomarkers (tested centrally on stored research samples)', 'timeFrame': '48 weeks'}, {'measure': 'To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on Serious adverse events.', 'timeFrame': '48 weeks'}, {'measure': 'To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on fasting lipids including: Total Cholesterol (mmol/L), LDL (mmol/L), High-Density Lipoproteins (HDL) (mmol/L), Triglycerides (mmol/L)', 'timeFrame': '48 weeks'}, {'measure': "To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on Atherosclerotic cardiovascular disease risk score (ASCVD) - calculation of a person's10-year risk (%) of having a cardiovascular problem.", 'timeFrame': '48 weeks'}, {'measure': 'To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on inflammatory biomarkers (tested centrally on stored research samples)', 'timeFrame': '48 weeks'}, {'measure': 'To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on serious adverse events', 'timeFrame': '48 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV'], 'conditions': ['HIV Infections', 'Weight Gain']}, 'descriptionModule': {'briefSummary': 'People with HIV are at a higher risk of cardiovascular diseases (CVD) due to the effects of the virus and its treatment. Integrase strand transfer inhibitors (INSTIs), a common HIV treatment, are associated with increased CVD risk and metabolic issues, such as weight gain and high blood pressure. Sodium-glucose cotransporter 2 (SGLT2) inhibitors, however, have been working well in reducing CVD events and hospitalizations due to heart failure, irrespective of diabetes presence. They also help in reducing weight and blood pressure. Pitavastatin has shown to work in lowering CVD events in people with HIV, but its availability is limited. This benefit is thought to be common to all statins, but this has not yet been confirmed. This study will examine the impact of dapagliflozin vs. placebo on metabolic parameters in people with HIV with high metabolic risk who are on INSTI-based ART.', 'detailedDescription': "This is a 2x2 factorial, randomised, placebo-controlled, double-blind, phase III/IV trial with two randomisations performed centrally via an on-line system, stratified by site. Participants will be randomised 1:1 to dapagliflozin 10mg vs. Placebo; this randomisation will be blinded. Participants will also be randomised 1:1 within each group to pitavastatin 4mg vs. rosuvastatin 10mg/ezetimibe 10mg; this randomisation will be open label.\n\nTherefore, participants will be randomised to one of 4 groups:\n\n1. Dapagliflozin 10mg + pitavastatin 4mg\n2. Dapagliflozin 10mg + rosuvastatin 10mg/ezetimibe 10mg\n3. Placebo + pitavastatin 4mg\n4. Placebo + rosuvastatin 10mg/ezetimibe 10mg\n\nWith the following 2-arm randomised comparisons:\n\n* Primary analysis hypothesis: a+b vs c+d (dapagliflozin vs placebo)\n* Secondary analysis hypothesis: a+c vs b+d (pitavastatin vs rosuvastatin 10mg/ezetimibe 10mg)\n\nThe study's primary and secondary endpoints described will assess both efficacy and safety/tolerability across randomisation arms. Follow up will continue to 48 weeks and endpoint measures will be obtained at 4, 12, 24, and 48 weeks. Primary endpoint is at 24 weeks. The total number of participants is 300, with 75 randomised to each of the groups as listed above."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 40-75 years and at least one of the following risk factors:\n\n 1. BMI \\> 7% increase or \\> 5kg weight gain since INSTI commencement, or\n 2. BMI ≥ 30 kg/m2\n2. BMI ≥18 kg/m2 prior to INSTI commencement\n3. Currently taking INSTI-based ART\n4. Sustained virologic response, defined as viral load \\<200 copies/mL for at least 12 months\n5. Current CD4 \\>250 cells/mm3\n6. Informed consent for trial participation\n\nExclusion Criteria:\n\n1. Currently taking a protease inhibitor\n2. Indicated to take or already taking high intensity statin\n3. estimated glomerular filtration rate (eGFR) \\< 30 ml/min/1.73m2\n4. Currently taking an SGLT-2 inhibitor or glucagon-like peptide 1 (GLP-1) agonist\n5. Absolute contraindication or absolute indication to SGLT2 inhibitor therapy\n6. Absolute contraindication to pitavastatin, rosuvastatin, ezetimibe or combination of rosuvastatin/ezetimibe\n7. Pregnant or breast feeding\n8. Severe hepatic impairment (Child Pugh B or C)\n9. Participants receiving any excluded/contraindicated medication\n10. Participants who are enrolled into an additional interventional study.\n11. Expected inability or unwillingness to participate in study procedures.\n12. In the opinion of the investigator, participation in a trial is not in the best interest of the patient.'}, 'identificationModule': {'nctId': 'NCT06317051', 'acronym': 'OPTIMAR', 'briefTitle': 'Optimising Metabolic Management for People With Human Immunodeficiency Virus (HIV) on Integrase Based Antiretroviral Therapy (ART)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kirby Institute'}, 'officialTitle': 'A Phase III/IV Factorial Randomized Double-blind Trial to Compare the Addition of Dapagliflozin vs Placebo and Rosuvastatin/Ezetimibe Versus Pitavastatin in Patients With HIV on Integrase Strand Transfer Inhibitor-based Antiretrovirals With Elevated Metabolic Risk', 'orgStudyIdInfo': {'id': 'OPTIMAR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dapagliflozin 10mg + pitavastatin 4mg', 'description': 'Dapagliflozin 10mg + pitavastatin 4mg given as daily tablets for 48 weeks', 'interventionNames': ['Drug: Dapagliflozin 10mg Tab', 'Drug: Pitavastatin 4 Mg Oral Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dapagliflozin 10mg + rosuvastatin 10mg/ezetimibe 10mg', 'description': 'Dapagliflozin 10mg + rosuvastatin 10mg/ezetimibe 10mg given as daily tablets for 48 weeks', 'interventionNames': ['Drug: Dapagliflozin 10mg Tab', 'Drug: Rosuvastatin and Ezetimibe']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + pitavastatin 4mg', 'description': 'Placebo + pitavastatin 4mg given as daily tablets for 48 weeks', 'interventionNames': ['Drug: Pitavastatin 4 Mg Oral Tablet', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + rosuvastatin 10mg/ezetimibe 10mg', 'description': 'Placebo + rosuvastatin 10mg/ezetimibe 10mg given as daily tablets for 48 weeks', 'interventionNames': ['Drug: Rosuvastatin and Ezetimibe', 'Drug: Placebo']}], 'interventions': [{'name': 'Dapagliflozin 10mg Tab', 'type': 'DRUG', 'otherNames': ['FORXIGA'], 'description': 'Dapagliflozin will be administered as a comparator to the placebo to assess its effects on weight reduction', 'armGroupLabels': ['Dapagliflozin 10mg + pitavastatin 4mg', 'Dapagliflozin 10mg + rosuvastatin 10mg/ezetimibe 10mg']}, {'name': 'Pitavastatin 4 Mg Oral Tablet', 'type': 'DRUG', 'otherNames': ['Livazo'], 'description': 'Pitavastatin tablets will be administered as a comparator to Rosuvastatin/Ezetimibe 10mg/10mg tablets to assess and compare their effects on LDL concentrations', 'armGroupLabels': ['Dapagliflozin 10mg + pitavastatin 4mg', 'Placebo + pitavastatin 4mg']}, {'name': 'Rosuvastatin and Ezetimibe', 'type': 'DRUG', 'description': 'Rosuvastatin/Ezetimibe 10mg/10mg tablets will be administered as a comparator to pitavastatin to assess and compare their effects on LDL concentrations', 'armGroupLabels': ['Dapagliflozin 10mg + rosuvastatin 10mg/ezetimibe 10mg', 'Placebo + rosuvastatin 10mg/ezetimibe 10mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The placebo tablets are visually identical to the active drug tablets and will be administered as a comparator to Dapagliflozin.', 'armGroupLabels': ['Placebo + pitavastatin 4mg', 'Placebo + rosuvastatin 10mg/ezetimibe 10mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Ramos Mejía', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '2010', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': "St Vincent's Hospital", 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '3084', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Austin Health', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '600113', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'CART-CRS', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Universiti Malaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'Abuja', 'country': 'Nigeria', 'facility': 'Institute of Human Virology, Nigeria', 'geoPoint': {'lat': 9.05785, 'lon': 7.49508}}, {'zip': '7925', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Desmond Tutu Health Foundation', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'HIV-NAT', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Kampala', 'country': 'Uganda', 'facility': 'Infectious Diseases Institute, Makerere University', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'city': 'Harare', 'country': 'Zimbabwe', 'facility': 'University of Zimbabwe Clinical Research Centre', 'geoPoint': {'lat': -17.82772, 'lon': 31.05337}}], 'overallOfficials': [{'name': 'Gail Matthews, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kirby Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kirby Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}