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

Sponsor
Kirby Institute
Study ID
NCT06317051
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10mg Tab — DRUG
    Dapagliflozin will be administered as a comparator to the placebo to assess its effects on weight reduction
  • Pitavastatin 4 Mg Oral Tablet — DRUG
    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 — DRUG
    Rosuvastatin/Ezetimibe 10mg/10mg tablets will be administered as a comparator to pitavastatin to assess and compare their effects on LDL concentrations
  • Placebo — DRUG
    The placebo tablets are visually identical to the active drug tablets and will be administered as a comparator to Dapagliflozin.

Study Details

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.

Key Dates

Start date
Dec 16, 2024
Status verified
Dec 2025
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dapagliflozin 10mg + pitavastatin 4mg
    Dapagliflozin 10mg + pitavastatin 4mg given as daily tablets for 48 weeks
  • Active Comparator: Dapagliflozin 10mg + rosuvastatin 10mg/ezetimibe 10mg
    Dapagliflozin 10mg + rosuvastatin 10mg/ezetimibe 10mg given as daily tablets for 48 weeks
  • Placebo Comparator: Placebo + pitavastatin 4mg
    Placebo + pitavastatin 4mg given as daily tablets for 48 weeks
  • Placebo Comparator: Placebo + rosuvastatin 10mg/ezetimibe 10mg
    Placebo + rosuvastatin 10mg/ezetimibe 10mg given as daily tablets for 48 weeks

Primary Outcome Measure

To assess the impact of dapagliflozin vs. placebo on weight reduction [ Time Frame: 24 weeks ]

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