nctId: NCT06317051 id: OPTIMAR briefTitle: Optimising Metabolic Management for People With Human Immunodeficiency Virus (HIV) on Integrase Based Antiretroviral Therapy (ART) acronym: OPTIMAR overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-07 date: 2026-12 date: 2024-03-19 date: 2024-03-19 name: Kirby Institute class: OTHER_GOV 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. conditions: HIV Infections conditions: Weight Gain studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: Dapagliflozin 10mg Tab name: Pitavastatin 4 Mg Oral Tablet name: Rosuvastatin and Ezetimibe name: Placebo measure: To assess the impact of dapagliflozin vs. placebo on weight reduction measure: To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe on low-density lipoproteins (LDL) concentration 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 measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on waist (cm) to hip (cm) ratio measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on waist (cm) to height (cm) ratio measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on systolic and diastolic blood pressure (mm Hg) 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. 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) measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on fasting glucose (mmol/L) measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on haemoglobin A1C (%) 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) measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on inflammatory biomarkers (tested centrally on stored research samples) measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on Serious adverse events. 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) 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. measure: To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on inflammatory biomarkers (tested centrally on stored research samples) measure: To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on serious adverse events sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False