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Clinical trial No longer in our active list Phase 3 Interventional Ages 40 to 75

Optimizing metabolic management for people with HIV on integrase-based therapy

Official title: 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

Run by Kirby Institute · NCT06317051 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study is testing if a diabetes medication can help people with HIV who are at risk for metabolic issues feel better while they are on specific HIV treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Ages40 Years to 75 Years
SexAll
Enrollment300 (estimated)
SponsorKirby Institute
Government
Locations3 sites (Sydney, New South Wales and 2 other locations)
Trial IDNCT06317051 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals aged 40-75 with HIV who have experienced significant weight gain or have a high BMI while on INSTI-based ART.

Probably not a fit

Patients currently taking protease inhibitors or those with severe renal or hepatic impairment may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, on metabolic parameters in individuals with HIV who are at high metabolic risk and currently on integrase strand transfer inhibitors (INSTIs). Participants will be randomly assigned to receive either dapagliflozin or a placebo, alongside either pitavastatin or a combination of rosuvastatin and ezetimibe. The study aims to assess both the efficacy and safety of these treatments over a 48-week period, with primary endpoints evaluated at 24 weeks. A total of 300 participants will be enrolled, with follow-up assessments at multiple time points.

Why it matters

Potential benefit: If successful, this study could lead to improved metabolic health and reduced cardiovascular risks for patients living with HIV.

How similar studies have gone: Previous studies have shown promising results with SGLT2 inhibitors in reducing cardiovascular risks, suggesting potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • St Vincent's Hospital
    Sydney, New South Wales, Australia     Recruiting
  • Austin Health
    Melbourne, Victoria, Australia     Recruiting
  • Cart-Crs
    Chennai, Tamil Nadu, India     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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HIV Infections 98Weight Gain 54Kirby Institute 8
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.