HIV InfectionsPhase 3OPTIMARNCT06317051
Optimising Metabolic Management for People With Human Immunodeficiency Virus (HIV) on Integrase Based Antiretroviral Therapy (ART)
A Phase 3 study testing Dapagliflozin 10mg Tab, Pitavastatin 4 Mg Oral Tablet and Rosuvastatin and Ezetimibe in people with HIV Infections and Weight Gain, run by Kirby Institute at 10 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- HIV Infections, Weight Gain
- What is being tested?
- Dapagliflozin 10mg Tab, Pitavastatin 4 Mg Oral Tablet and Rosuvastatin and Ezetimibe
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 10 sitesin 9 countries
- Study dates
- 16 Dec 2024to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently taking a protease inhibitor
- Indicated to take or already taking high intensity statin
- estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
- Currently taking an SGLT-2 inhibitor or glucagon-like peptide 1 (GLP-1) agonist
- Absolute contraindication or absolute indication to SGLT2 inhibitor therapy
- Absolute contraindication to pitavastatin, rosuvastatin, ezetimibe or combination of rosuvastatin/ezetimibe
Show all 12Show fewer
- Pregnant or breast feeding
- Severe hepatic impairment (Child Pugh B or C)
- Participants receiving any excluded/contraindicated medication
- 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.
Trial locations and contacts
10 sites in 9 countries.
10 sites in 9 countries
Australia2 sites
Austin Health
Melbourne, Victoria, 3084
St Vincent's Hospital
Sydney, New South Wales, 2010
About this study
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
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.
Read the detailed description
This is a 2x2 factorial, randomised, placebo-controlled, double-blind, phase III/IV trial with two randomisations performed centrally via an on-line system, stratified by site. Participants will be randomised 1:1 to dapagliflozin 10mg vs. Placebo; this randomisation will be blinded. Participants will also be randomised 1:1 within each group to pitavastatin 4mg vs. rosuvastatin 10mg/ezetimibe 10mg; this randomisation will be open label.
Therefore, participants will be randomised to one of 4 groups:
- Dapagliflozin 10mg + pitavastatin 4mg
- Dapagliflozin 10mg + rosuvastatin 10mg/ezetimibe 10mg
- Placebo + pitavastatin 4mg
- Placebo + rosuvastatin 10mg/ezetimibe 10mg
With the following 2-arm randomised comparisons:
- Primary analysis hypothesis: a+b vs c+d (dapagliflozin vs placebo)
- Secondary analysis hypothesis: a+c vs b+d (pitavastatin vs rosuvastatin 10mg/ezetimibe 10mg)
The study's primary and secondary endpoints described will assess both efficacy and safety/tolerability across randomisation arms. Follow up will continue to 48 weeks and endpoint measures will be obtained at 4, 12, 24, and 48 weeks. Primary endpoint is at 24 weeks. The total number of participants is 300, with 75 randomised to each of the groups as listed above.
All randomised participants who have not withdrawn from the study will be invited to attend an optional observational follow-up visit at Week 96 (±6 weeks). The visit will collect longer-term post-treatment clinical, metabolic, cardiovascular risk, liver-related, medication use and safety data. No study drug will be supplied beyond Week 48, and no Week 96 CT coronary angiogram is planned. Week 96 data will be analysed separately as exploratory observational post-treatment follow-up data and will not alter the primary Week 24 or Week 48 analyses.
- Conditions
- HIV Infections, Weight Gain
- Being tested
- Dapagliflozin 10mg Tab, Pitavastatin 4 Mg Oral Tablet, Rosuvastatin and Ezetimibe, Placebo
- Keywords
- HIV
- Medical subject headings
- HIV Infections, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mg TabDrug
Also called FORXIGA
Dapagliflozin will be administered as a comparator to the placebo to assess its effects on weight reduction
Pitavastatin 4 Mg Oral TabletDrug
Also called Livazo
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 EzetimibeDrug
Rosuvastatin/Ezetimibe 10mg/10mg tablets will be administered as a comparator to pitavastatin to assess and compare their effects on LDL concentrations
PlaceboDrug
The placebo tablets are visually identical to the active drug tablets and will be administered as a comparator to Dapagliflozin.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin 10mg + pitavastatin 4mg | Active comparator | Dapagliflozin 10mg + pitavastatin 4mg given as daily tablets for 48 weeks Receives: Drug: Dapagliflozin 10mg Tab; Drug: Pitavastatin 4 Mg Oral Tablet |
| Dapagliflozin 10mg + rosuvastatin 10mg/ezetimibe 10mg | Active comparator | Dapagliflozin 10mg + rosuvastatin 10mg/ezetimibe 10mg given as daily tablets for 48 weeks Receives: Drug: Dapagliflozin 10mg Tab; Drug: Rosuvastatin and Ezetimibe |
| Placebo + pitavastatin 4mg | Placebo comparator | Placebo + pitavastatin 4mg given as daily tablets for 48 weeks Receives: Drug: Pitavastatin 4 Mg Oral Tablet; Drug: Placebo |
| Placebo + rosuvastatin 10mg/ezetimibe 10mg | Placebo comparator | Placebo + rosuvastatin 10mg/ezetimibe 10mg given as daily tablets for 48 weeks Receives: Drug: Rosuvastatin and Ezetimibe; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the impact of dapagliflozin vs. placebo on weight reduction
Mean reduction change in body weight across treatment arms at 24 weeks, defined as absolute body weight change.
Measured: 24 weeks
To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe on low-density lipoproteins (LDL) concentration
Mean change in LDL as absolute change from baseline to 24 weeks across treatment arms
Measured: 24 weeks
Secondary outcomes (15)
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on body mass index (BMI )- weight and height will be combined to report BMI in kg/m^2
Measured: 48 weeks
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on waist (cm) to hip (cm) ratio
Measured: 48 weeks
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on waist (cm) to height (cm) ratio
Measured: 48 weeks
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on systolic and diastolic blood pressure (mm Hg)
Measured: 48 weeks
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on Atherosclerotic cardiovascular disease risk score (ASCVD) - calculation of a person's10-year risk (%) of having a cardiovascular problem.
Measured: 48 weeks
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on fasting lipids including: Total Cholesterol (mmol/L), LDL (mmol/L), High-Density Lipoproteins (HDL) (mmol/L), Triglycerides (mmol/L)
Measured: 48 weeks
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on fasting glucose (mmol/L)
Measured: 48 weeks
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on haemoglobin A1C (%)
Measured: 48 weeks
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on measures of fatty liver disease: Liver Function Tests - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (U/L), FibroScan (kPa)
Measured: 48 weeks
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on inflammatory biomarkers (tested centrally on stored research samples)
Measured: 48 weeks
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on Serious adverse events.
Measured: 48 weeks
To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on fasting lipids including: Total Cholesterol (mmol/L), LDL (mmol/L), High-Density Lipoproteins (HDL) (mmol/L), Triglycerides (mmol/L)
Measured: 48 weeks
To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on Atherosclerotic cardiovascular disease risk score (ASCVD) - calculation of a person's10-year risk (%) of having a cardiovascular problem.
Measured: 48 weeks
To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on inflammatory biomarkers (tested centrally on stored research samples)
Measured: 48 weeks
To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on serious adverse events
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start16 Dec 2024
- Primary completionJul 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gail Matthews, MD, Principal investigator, Kirby Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317051
- Sponsor's protocol ID
- OPTIMAR
- Acronym
- OPTIMAR
- Status last verified
- Dec 2025
- First submitted
- 21 Feb 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nyein PP, Haskelberg H, Martinello M, Lowe M, Goodman-Meza D, Avihingsanon A, Kelleher AD, Rodgers A, Schutte AE, Nnakelu EC, Byakwaga H, Trevillyan J, Losso M, Kumarasamy N, Azwa RISR, Kaplan R, Clifton B, Arnott C, Dharan NJ, Petoumenos K, Matthews GV. Optimizing metabolic management on integrase-based ART (OPTIMAR): study protocol for a 2 x 2 factorial, randomised, double-blind placebo-controlled trial to compare the addition of dapagliflozin versus placebo, and rosuvastatin plus ezetimibe versus pitavastatin, in people with HIV on integrase strand transfer inhibitor-based antiretroviral therapy with elevated metabolic risk. Trials. 2026 Apr 29;27(1):445. doi: 10.1186/s13063-026-09723-2.
PubMed 42050587
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06317051
- Acronym / sponsor ID
- OPTIMAR / OPTIMAR
- Conditions
- HIV Infections, Weight Gain
- Keywords
- HIV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a 2x2 factorial, randomised, placebo-controlled, double-blind, phase III/IV trial with two randomisations performed centrally via an on-line system, stratified by site. Participants will be randomised 1:1 to dapagliflozin 10mg vs. Placebo; this randomisation will be blinded. Participants will also be randomised 1:1 within each group to pitavastatin 4mg vs. rosuvastatin 10mg/ezetimibe 10mg; this randomisation will be open label.
Therefore, participants will be randomised to one of 4 groups:
- Dapagliflozin 10mg + pitavastatin 4mg
- Dapagliflozin 10mg + rosuvastatin 10mg/ezetimibe 10mg
- Placebo + pitavastatin 4mg
- Placebo + rosuvastatin 10mg/ezetimibe 10mg
With the following 2-arm randomised comparisons:
- Primary analysis hypothesis: a+b vs c+d (dapagliflozin vs placebo)
- Secondary analysis hypothesis: a+c vs b+d (pitavastatin vs rosuvastatin 10mg/ezetimibe 10mg)
The study's primary and secondary endpoints described will assess both efficacy and safety/tolerability across randomisation arms. Follow up will continue to 48 weeks and endpoint measures will be obtained at 4, 12, 24, and 48 weeks. Primary endpoint is at 24 weeks. The total number of participants is 300, with 75 randomised to each of the groups as listed above.
All randomised participants who have not withdrawn from the study will be invited to attend an optional observational follow-up visit at Week 96 (±6 weeks). The visit will collect longer-term post-treatment clinical, metabolic, cardiovascular risk, liver-related, medication use and safety data. No study drug will be supplied beyond Week 48, and no Week 96 CT coronary angiogram is planned. Week 96 data will be analysed separately as exploratory observational post-treatment follow-up data and will not alter the primary Week 24 or Week 48 analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin 10mg + pitavastatin 4mg | Active comparator | Drug: Dapagliflozin 10mg Tab, Drug: Pitavastatin 4 Mg Oral TabletDapagliflozin 10mg + pitavastatin 4mg given as daily tablets for 48 weeks |
| Dapagliflozin 10mg + rosuvastatin 10mg/ezetimibe 10mg | Active comparator | Drug: Dapagliflozin 10mg Tab, Drug: Rosuvastatin and EzetimibeDapagliflozin 10mg + rosuvastatin 10mg/ezetimibe 10mg given as daily tablets for 48 weeks |
| Placebo + pitavastatin 4mg | Placebo comparator | Drug: Pitavastatin 4 Mg Oral Tablet, Drug: PlaceboPlacebo + pitavastatin 4mg given as daily tablets for 48 weeks |
| Placebo + rosuvastatin 10mg/ezetimibe 10mg | Placebo comparator | Drug: Rosuvastatin and Ezetimibe, Drug: PlaceboPlacebo + rosuvastatin 10mg/ezetimibe 10mg given as daily tablets for 48 weeks |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 40-75 years and at least one of the following risk factors:
- 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
Key exclusion criteria (12 listed)
- Currently taking a protease inhibitor
- Indicated to take or already taking high intensity statin
- estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
- Currently taking an SGLT-2 inhibitor or glucagon-like peptide 1 (GLP-1) agonist
- Absolute contraindication or absolute indication to SGLT2 inhibitor therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10mg TabAlso: FORXIGADapagliflozin will be administered as a comparator to the placebo to assess its effects on weight reduction | Drug | Dapagliflozin 10mg + pitavastatin 4mg, Dapagliflozin 10mg + rosuvastatin 10mg/ezetimibe 10mg |
| Pitavastatin 4 Mg Oral TabletAlso: LivazoPitavastatin tablets will be administered as a comparator to Rosuvastatin/Ezetimibe 10mg/10mg tablets to assess and compare their effects on LDL concentrations | Drug | Dapagliflozin 10mg + pitavastatin 4mg, Placebo + pitavastatin 4mg |
| Rosuvastatin and EzetimibeRosuvastatin/Ezetimibe 10mg/10mg tablets will be administered as a comparator to pitavastatin to assess and compare their effects on LDL concentrations | Drug | Dapagliflozin 10mg + rosuvastatin 10mg/ezetimibe 10mg, Placebo + rosuvastatin 10mg/ezetimibe 10mg |
| PlaceboThe placebo tablets are visually identical to the active drug tablets and will be administered as a comparator to Dapagliflozin. | Drug | Placebo + pitavastatin 4mg, Placebo + rosuvastatin 10mg/ezetimibe 10mg |
Primary outcome
To assess the impact of dapagliflozin vs. placebo on weight reduction
Time frame: 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
Time frame: 24 weeks
Mean change in LDL as absolute change from baseline to 24 weeks across treatment arms
15 secondary outcomes
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on body mass index (BMI )- weight and height will be combined to report BMI in kg/m^2
Time frame: 48 weeks
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on waist (cm) to hip (cm) ratio
Time frame: 48 weeks
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on waist (cm) to height (cm) ratio
Time frame: 48 weeks
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on systolic and diastolic blood pressure (mm Hg)
Time frame: 48 weeks
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on Atherosclerotic cardiovascular disease risk score (ASCVD) - calculation of a person's10-year risk (%) of having a cardiovascular problem.
Time frame: 48 weeks
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on fasting lipids including: Total Cholesterol (mmol/L), LDL (mmol/L), High-Density Lipoproteins (HDL) (mmol/L), Triglycerides (mmol/L)
Time frame: 48 weeks
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on fasting glucose (mmol/L)
Time frame: 48 weeks
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on haemoglobin A1C (%)
Time frame: 48 weeks
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on measures of fatty liver disease: Liver Function Tests - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (U/L), FibroScan (kPa)
Time frame: 48 weeks
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on inflammatory biomarkers (tested centrally on stored research samples)
Time frame: 48 weeks
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on Serious adverse events.
Time frame: 48 weeks
To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on fasting lipids including: Total Cholesterol (mmol/L), LDL (mmol/L), High-Density Lipoproteins (HDL) (mmol/L), Triglycerides (mmol/L)
Time frame: 48 weeks
To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on Atherosclerotic cardiovascular disease risk score (ASCVD) - calculation of a person's10-year risk (%) of having a cardiovascular problem.
Time frame: 48 weeks
To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on inflammatory biomarkers (tested centrally on stored research samples)
Time frame: 48 weeks
To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on serious adverse events
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Derived from this study: PubMed 42050587Nyein PP, Haskelberg H, Martinello M, Lowe M, Goodman-Meza D, Avihingsanon A, Kelleher AD, Rodgers A, Schutte AE, Nnakelu EC, Byakwaga H, Trevillyan J, Losso M, Kumarasamy N, Azwa RISR, Kaplan R, Clifton B, Arnott C, Dharan NJ, Petoumenos K, Matthews GV. Optimizing metabolic management on integrase-based ART (OPTIMAR): study protocol for a 2 x 2 factorial, randomised, double-blind placebo-controlled trial to compare the addition of dapagliflozin versus placebo, and rosuvastatin plus ezetimibe versus pitavastatin, in people with HIV on integrase strand transfer inhibitor-based antiretroviral therapy with elevated metabolic risk. Trials. 2026 Apr 29;27(1):445. doi: 10.1186/s13063-026-09723-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gail Matthews, MD principal investigator
Kirby Institute
10 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapagliflozin 10mg Tab, Pitavastatin 4 Mg Oral Tablet and Rosuvastatin and Ezetimibe in people with HIV Infections and Weight Gain, run by Kirby Institute at 10 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia, Argentina, India, Malaysia, Nigeria and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the impact of dapagliflozin vs. placebo on weight reduction (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06317051, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.