A Phase 3 interventional study of Dapagliflozin 10mg Tab and Pitavastatin 4 Mg Oral Tablet in HIV Infections and Weight Gain, sponsored by Kirby Institute. Active, not recruiting at 10 sites in 9 countries. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Kirby Institute · Phase 3, Interventional, and Treatment
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.
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:
With the following 2-arm randomised comparisons:
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All randomised participants who have not withdrawn from the study will be invited to attend an optional observational follow-up visit at Week 96 (±6 weeks).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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's planned enrollment of 300 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Kirby Institute is the lead sponsor of 94 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age 40-75 years and at least one of the following risk factors:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dapagliflozin 10mg + pitavastatin 4mg given as daily tablets for 48 weeks
Drug: Dapagliflozin 10mg Tab · Drug: Pitavastatin 4 Mg Oral Tablet
Dapagliflozin 10mg + rosuvastatin 10mg/ezetimibe 10mg given as daily tablets for 48 weeks
Drug: Dapagliflozin 10mg Tab · Drug: Rosuvastatin and Ezetimibe
Placebo + pitavastatin 4mg given as daily tablets for 48 weeks
Drug: Pitavastatin 4 Mg Oral Tablet · Drug: Placebo
Placebo + rosuvastatin 10mg/ezetimibe 10mg given as daily tablets for 48 weeks
Drug: Rosuvastatin and Ezetimibe · Drug: Placebo
Dapagliflozin will be administered as a comparator to the placebo to assess its effects on weight reduction
Also known as: FORXIGA
Pitavastatin tablets will be administered as a comparator to Rosuvastatin/Ezetimibe 10mg/10mg tablets to assess and compare their effects on LDL concentrations
Also known as: Livazo
Drug pages: Rosuvastatin · Ezetimibe
Rosuvastatin/Ezetimibe 10mg/10mg tablets will be administered as a comparator to pitavastatin to assess and compare their effects on LDL concentrations
The placebo tablets are visually identical to the active drug tablets and will be administered as a comparator to Dapagliflozin.
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.
Time frame: 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
Time frame: 24 weeks
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
Change in body weight from baseline to Week 96
Absolute change in body weight, measured in kilograms, from baseline to Week 96.
Time frame: Baseline to Week 96
Change in waist-to-hip and waist-to-height ratios from baseline to Week 96
Change in waist-to-hip ratio and waist-to-height ratio from baseline to Week 96.
Time frame: Baseline to Week 96
Change in systolic and diastolic blood pressure from baseline to Week 96
Change in resting systolic and diastolic blood pressure, measured in mmHg, from baseline to Week 96.
Time frame: Baseline to Week 96
Change in atherosclerotic cardiovascular disease risk score from baseline to Week 96
Change in calculated 10-year atherosclerotic cardiovascular disease risk, expressed as a percentage, from baseline to Week 96.
Time frame: Baseline to Week 96
Change in fasting lipids from baseline to Week 96
Change in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides, measured in mmol/L, from baseline to Week 96.
Time frame: Baseline to Week 96
Clinical events of interest after completion of study treatment
Number and type of protocol-specified clinical events of interest reported after the Week 48 visit.
Time frame: Week 48 to Week 96
Medication use after completion of study treatment
Current antiretroviral therapy and use of relevant concomitant medications, including lipid-lowering therapy, SGLT2 inhibitors, GLP-1 receptor agonists, diabetes medications, antihypertensives and cardiovascular medications.
Time frame: At Week 96
Change in liver fibrosis measures from baseline to Week 96
Change in FibroScan liver stiffness, measured in kPa where available, or AST-to-Platelet Ratio Index where FibroScan is unavailable.
Time frame: Baseline to Week 96
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dapagliflozin
Kirby Institute