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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06317051
Registration number
NCT06317051
Ethics application status
Date submitted
21/02/2024
Date registered
19/03/2024
Date last updated
19/06/2025
Titles & IDs
Public title
Optimising Metabolic Management for People With Human Immunodeficiency Virus (HIV) on Integrase Based Antiretroviral Therapy (ART)
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Scientific 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
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Secondary ID [1]
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OPTIMAR
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Universal Trial Number (UTN)
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Trial acronym
OPTIMAR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV Infections
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Weight Gain
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Condition category
Condition code
Diet and Nutrition
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dapagliflozin 10mg Tab
Treatment: Drugs - Pitavastatin 4 Mg Oral Tablet
Treatment: Drugs - Rosuvastatin and Ezetimibe
Treatment: Drugs - Placebo
Active comparator: Dapagliflozin 10mg + pitavastatin 4mg - Dapagliflozin 10mg + pitavastatin 4mg given as daily tablets for 48 weeks
Active comparator: Dapagliflozin 10mg + rosuvastatin 10mg/ezetimibe 10mg - Dapagliflozin 10mg + rosuvastatin 10mg/ezetimibe 10mg given as daily tablets for 48 weeks
Placebo comparator: Placebo + pitavastatin 4mg - Placebo + pitavastatin 4mg given as daily tablets for 48 weeks
Placebo comparator: Placebo + rosuvastatin 10mg/ezetimibe 10mg - Placebo + rosuvastatin 10mg/ezetimibe 10mg given as daily tablets for 48 weeks
Treatment: Drugs: Dapagliflozin 10mg Tab
Dapagliflozin will be administered as a comparator to the placebo to assess its effects on weight reduction
Treatment: Drugs: Pitavastatin 4 Mg Oral Tablet
Pitavastatin tablets will be administered as a comparator to Rosuvastatin/Ezetimibe 10mg/10mg tablets to assess and compare their effects on LDL concentrations
Treatment: Drugs: Rosuvastatin and Ezetimibe
Rosuvastatin/Ezetimibe 10mg/10mg tablets will be administered as a comparator to pitavastatin to assess and compare their effects on LDL concentrations
Treatment: Drugs: Placebo
The placebo tablets are visually identical to the active drug tablets and will be administered as a comparator to Dapagliflozin.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To assess the impact of dapagliflozin vs. placebo on weight reduction
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Assessment method [1]
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Mean reduction change in body weight across treatment arms at 24 weeks, defined as absolute body weight change.
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Timepoint [1]
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24 weeks
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Primary outcome [2]
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To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe on low-density lipoproteins (LDL) concentration
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Assessment method [2]
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Mean change in LDL as absolute change from baseline to 24 weeks across treatment arms
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Timepoint [2]
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24 weeks
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Secondary outcome [1]
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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
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Assessment method [1]
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Timepoint [1]
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48 weeks
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Secondary outcome [2]
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To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on waist (cm) to hip (cm) ratio
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Assessment method [2]
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Timepoint [2]
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48 weeks
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Secondary outcome [3]
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To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on waist (cm) to height (cm) ratio
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Assessment method [3]
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Timepoint [3]
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48 weeks
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Secondary outcome [4]
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To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on systolic and diastolic blood pressure (mm Hg)
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Assessment method [4]
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Timepoint [4]
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48 weeks
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Secondary outcome [5]
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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.
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Assessment method [5]
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Timepoint [5]
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48 weeks
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Secondary outcome [6]
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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)
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Assessment method [6]
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Timepoint [6]
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48 weeks
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Secondary outcome [7]
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To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on fasting glucose (mmol/L)
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Assessment method [7]
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Timepoint [7]
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48 weeks
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Secondary outcome [8]
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To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on haemoglobin A1C (%)
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Assessment method [8]
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Timepoint [8]
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48 weeks
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Secondary outcome [9]
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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)
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Assessment method [9]
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Timepoint [9]
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48 weeks
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Secondary outcome [10]
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To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on inflammatory biomarkers (tested centrally on stored research samples)
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Assessment method [10]
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Timepoint [10]
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48 weeks
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Secondary outcome [11]
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To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on Serious adverse events.
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Assessment method [11]
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Timepoint [11]
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48 weeks
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Secondary outcome [12]
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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)
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Assessment method [12]
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Timepoint [12]
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48 weeks
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Secondary outcome [13]
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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.
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Assessment method [13]
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0
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Timepoint [13]
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48 weeks
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Secondary outcome [14]
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To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on inflammatory biomarkers (tested centrally on stored research samples)
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Assessment method [14]
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Timepoint [14]
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48 weeks
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Secondary outcome [15]
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To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on serious adverse events
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Assessment method [15]
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Timepoint [15]
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48 weeks
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Eligibility
Key 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
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Minimum age
40
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Factorial
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/12/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2026
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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St Vincent's Hospital - Sydney
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Recruitment hospital [2]
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Austin Health - Melbourne
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment postcode(s) [2]
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3084 - Melbourne
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Recruitment outside Australia
Country [1]
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India
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State/province [1]
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Tamil Nadu
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Country [2]
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Nigeria
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State/province [2]
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Abuja
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Country [3]
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South Africa
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State/province [3]
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Cape Town
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Country [4]
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Thailand
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State/province [4]
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Bangkok
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Kirby Institute
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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. 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.
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Trial website
https://clinicaltrials.gov/study/NCT06317051
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gail Matthews, MD
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Address
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Kirby Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Hila Haskelberg, PhD
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Address
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Country
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Phone
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+61 2 9348 1607
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06317051
Download to PDF