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

Condition(s) studied

Investigational drug(s) / intervention(s)

Dapagliflozin 10mg Tab: Dapagliflozin will be administered as a comparator to the placebo to assess its effects on weight reduction

Pitavastatin 4 Mg Oral Tablet: Pitavastatin tablets will be administered as a comparator to Rosuvastatin/Ezetimibe 10mg/10mg tablets to assess and compare their effects on LDL concentrations

Rosuvastatin and Ezetimibe: Rosuvastatin/Ezetimibe 10mg/10mg tablets will be administered as a comparator to pitavastatin to assess and compare their effects on LDL concentrations

Placebo: The placebo tablets are visually identical to the active drug tablets and will be administered as a comparator to Dapagliflozin.

Study summary

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.

Eligibility

Primary outcome measure(s)

• To assess the impact of dapagliflozin vs. placebo on weight reduction — 24 weeks
  Mean reduction change in body weight across treatment arms at 24 weeks, defined as absolute body weight change.
• To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe on low-density lipoproteins (LDL) concentration — 24 weeks
  Mean change in LDL as absolute change from baseline to 24 weeks across treatment arms

Trial sites (10)