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HIV heart risk: can two drug combos tame weight and cholesterol?

NCT ID NCT06317051

Disease control Sponsor: Kirby Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This study tests two drug combinations in 300 people with HIV who have gained weight or have high cholesterol. One part compares dapagliflozin (a diabetes drug) to a placebo for weight loss. The other compares a two-drug statin combo to a single statin for lowering cholesterol. The goal is to reduce heart disease risk in this group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dapagliflozin, Rosuvastatin/Ezetimibe, Pitavastatin
What this could lead to
If successful, this could offer a way to manage weight and cholesterol in people with HIV, reducing their risk of heart disease.
What could go wrong
This is a mid-stage trial with 300 participants, so results may not apply to everyone. The drugs may cause side effects like muscle pain or kidney issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease Weight Gain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV infections Weight gain

Contacts and locations

Locations

  • Austin Health

    Melbourne, Victoria, 3084, Australia

  • CART-CRS

    Chennai, Tamil Nadu, 600113, India

  • Desmond Tutu Health Foundation

    Cape Town, 7925, South Africa

  • HIV-NAT

    Bangkok, Thailand

  • Hospital Ramos Mejía

    Buenos Aires, Argentina

  • Infectious Diseases Institute, Makerere University

    Kampala, Uganda

  • Institute of Human Virology, Nigeria

    Abuja, Nigeria

  • St Vincent's Hospital

    Sydney, New South Wales, 2010, Australia

  • Universiti Malaya Medical Centre

    Kuala Lumpur, Malaysia

  • University of Zimbabwe Clinical Research Centre

    Harare, Zimbabwe

More trials for these conditions

Other studies related to the condition(s) this trial covers.