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

OPTIMAR

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.

2024-08-01

2025-07-01

2026-12-01

Not yet recruiting

Early phase I

300

Inclusion Criteria: 1. Age 40-75 years and at least one of the following risk factors: 1. BMI \> 7% increase or \> 5kg weight gain since INSTI commencement, or 2. BMI ≥ 30 kg/m2 2. BMI ≥18 kg/m2 prior to INSTI commencement 3. Currently taking INSTI-based ART 4. Sustained virologic response, defined as viral load \<200 copies/mL for at least 12 months 5. CD4 \>250 cells/mm3 6. Informed consent for trial participation Exclusion Criteria: 1. Currently taking a protease inhibitor 2. Indicated to take or already taking high intensity statin 3. estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2 4. Currently taking an SGLT-2 inhibitor or glucagon-like peptide 1 (GLP-1) agonist 5. Absolute contraindication or absolute indication to SGLT2 inhibitor therapy 6. Absolute contraindication to pitavastatin, rosuvastatin, ezetimibe or combination of rosuvastatin/ezetimibe 7. Pregnant or breast feeding 8. Severe hepatic impairment (Child Pugh B or C) 9. Participants receiving any excluded/contraindicated medication 10. Participants who are enrolled into an additional interventional study. 11. Expected inability or unwillingness to participate in study procedures. 12. In the opinion of the investigator, participation in a trial is not in the best interest of the patient.

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2024-03-19