Optimising Metabolic Management for People With Human Immunodeficiency Virus (HIV) on Integrase Based Antiretroviral Therapy (ART)

Launched by KIRBY INSTITUTE · Mar 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called dapagliflozin affects people with HIV who are at higher risk for heart problems and weight gain due to their treatment. The trial will compare the effects of dapagliflozin to a placebo (a treatment that looks like the real drug but has no active ingredients) to see if it can help with weight, blood pressure, and other health markers in people taking a specific type of HIV medication known as integrase inhibitors.

To participate in the trial, individuals must be between 40 and 75 years old and have experienced significant weight gain since starting their HIV treatment or have a high body mass index (BMI). They should also have been successfully managing their HIV for at least a year. Participants can expect regular health check-ups and monitoring throughout the study. It’s important to note that those taking certain other medications, pregnant or breastfeeding, or with specific health conditions may not be eligible for this trial.

Gender

ALL

Eligibility criteria

• 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. Current 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.