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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

Titles & IDs
Public title
Optimising Metabolic Management for People With Human Immunodeficiency Virus (HIV) on Integrase Based Antiretroviral Therapy (ART)
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
Secondary ID [1] 0 0
OPTIMAR
Universal Trial Number (UTN)
Trial acronym
OPTIMAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Weight Gain 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the impact of dapagliflozin vs. placebo on weight reduction
Timepoint [1] 0 0
24 weeks
Primary outcome [2] 0 0
To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe on low-density lipoproteins (LDL) concentration
Timepoint [2] 0 0
24 weeks
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
48 weeks
Secondary outcome [2] 0 0
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on waist (cm) to hip (cm) ratio
Timepoint [2] 0 0
48 weeks
Secondary outcome [3] 0 0
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on waist (cm) to height (cm) ratio
Timepoint [3] 0 0
48 weeks
Secondary outcome [4] 0 0
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on systolic and diastolic blood pressure (mm Hg)
Timepoint [4] 0 0
48 weeks
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
48 weeks
Secondary outcome [6] 0 0
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)
Timepoint [6] 0 0
48 weeks
Secondary outcome [7] 0 0
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on fasting glucose (mmol/L)
Timepoint [7] 0 0
48 weeks
Secondary outcome [8] 0 0
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on haemoglobin A1C (%)
Timepoint [8] 0 0
48 weeks
Secondary outcome [9] 0 0
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)
Timepoint [9] 0 0
48 weeks
Secondary outcome [10] 0 0
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on inflammatory biomarkers (tested centrally on stored research samples)
Timepoint [10] 0 0
48 weeks
Secondary outcome [11] 0 0
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on Serious adverse events.
Timepoint [11] 0 0
48 weeks
Secondary outcome [12] 0 0
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)
Timepoint [12] 0 0
48 weeks
Secondary outcome [13] 0 0
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.
Timepoint [13] 0 0
48 weeks
Secondary outcome [14] 0 0
To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on inflammatory biomarkers (tested centrally on stored research samples)
Timepoint [14] 0 0
48 weeks
Secondary outcome [15] 0 0
To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on serious adverse events
Timepoint [15] 0 0
48 weeks

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
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [2] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
3084 - Melbourne
Recruitment outside Australia
Country [1] 0 0
India
State/province [1] 0 0
Tamil Nadu

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gail Matthews, MD
Address 0 0
Kirby Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Hila Haskelberg, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 2 9348 1607
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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