NCT06317051Active, not recruitingPhase 3
Optimising Metabolic Management for People With Human Immunodeficiency Virus (HIV) on Integrase Based Antiretroviral Therapy (ART)
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
Source: ClinicalTrials.gov · Last updated 22 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 21 Feb 2024
- Start date
- 16 Dec 2024
- Primary completion date
- Jul 2026
- Lead sponsor
- Kirby Institute
- Diseases
- HIV
- NCT number
- NCT06317051
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 300
- From 16 Dec 2024 to the primary completion date, Jul 2026
- 10 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking a protease inhibitor
- Currently taking an SGLT-2 inhibitor or glucagon-like peptide 1 (GLP-1) agonist
- Absolute contraindication or absolute indication to SGLT2 inhibitor therapy
- Participants receiving any excluded/contraindicated medication
Other illness
- Severe hepatic impairment (Child Pugh B or C)
Lab values
- estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2
Other
- Indicated to take or already taking high intensity statin
- Absolute contraindication to pitavastatin, rosuvastatin, ezetimibe or combination of rosuvastatin/ezetimibe
- Pregnant or breast feeding
- Participants who are enrolled into an additional interventional study.
- Expected inability or unwillingness to participate in study procedures.
- In the opinion of the investigator, participation in a trial is not in the best interest of the patient.
Who the study is looking for
- Age 40-75 years and at least one of the following risk factors:
- BMI \> 7% increase or \> 5kg weight gain since INSTI commencement, or
- BMI ≥ 30 kg/m2
- BMI ≥18 kg/m2 prior to INSTI commencement
- Currently taking INSTI-based ART
- Sustained virologic response, defined as viral load \<200 copies/mL for at least 12 months
- Current CD4 \>250 cells/mm3
- Informed consent for trial participation
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Ramos Mejia Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Austin Health Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| St Vincent's Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| CART-CRS Coordinator of this site? Confirm its status | Chennai | India | Unknown status |
| Universiti Malaya Medical Centre Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| Institute of Human Virology, Nigeria Coordinator of this site? Confirm its status | Abuja | Nigeria | Unknown status |
| HIV-NAT Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Infectious Diseases Institute, Makerere University Coordinator of this site? Confirm its status | Kampala | Uganda | Unknown status |
| Desmond Tutu Health Foundation Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| University of Zimbabwe Clinical Research Centre Coordinator of this site? Confirm its status | Harare | Zimbabwe | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.