MCAZ CTR:: Applications

NCT06317051

03-07-2024

PUBLIC TITLE/ACRONYM	OPTImising Metabolic management on Integrase based ART (OPTIMAR)
Scientific Title	A Phase III/IV factorial randomised double-blind trial to compare the addition of dapagliflozin versus placebo, and rosuvastatin/ezetimibe versus pitavastatin, in patients with HIV on integrase strand transfer inhibitor-based antiretroviral therapy with e
Primary Sponsor Details
Sponsors *	University of New South Wales
Secondary Sponsor Details
Contact for Public Queries
Name	Professor Margaret Ziona Borok
Designation	Principal Investigator
Email	mborok@mweb.co.zw
Phone number	+263712400713
Postal Address	Department of Medicine, University Of Zimbabwe Faculty
Affiliation
Contact for Scientific Queries
Name	Professor Margaret Borok
Designation	Principal Investigator
Email	mborok@mweb.co.zw
Phone number	+263712400713
Postal Address	Department of Medicine, University Of Zimbabwe Faculty
Affiliation
Countries of Recruitment
Australia, United Kingdom, Thailand, Malaysia, India, South-Africa, Nigeria, Zimbabwe, Uganda and Argentin

Source of Funds	University of New South Wales

Health Condition(s) or Problem(s) Studied	Research question to be addressed by this proposal is to to examine the feasibility, benefits and risks of adding a sodium-glucose cotransporter 2 (SGLT2) inhibitor (dapagliflozin 10 mg) to INSTI-based ART in PWH with elevated metabolic risk (in OPTIMAR as determined by weight gain/obesity after commencing INSTI therapy). SGLT2 inhibitors have been shown to reduce major adverse cardiovascular events (MACE) in other high-risk groups, but to date, have not been trialed in PWH.

Health Condition(s) or Problem(s) Studied

Research question to be addressed by this proposal is to to examine the feasibility, benefits and risks of adding a sodium-glucose cotransporter 2 (SGLT2) inhibitor (dapagliflozin 10 mg) to INSTI-based ART in PWH with elevated metabolic risk (in OPTIMAR as determined by weight gain/obesity after commencing INSTI therapy). SGLT2 inhibitors have been shown to reduce major adverse cardiovascular events (MACE) in other high-risk groups, but to date, have not been trialed in PWH.

Medicine Name	Dapagliflozin,Pitavastatin,Rosuvastatin,Ezetimibe
Quantity of medicine required	Dapagliflozin 10mg,Pitavastatin4mg,Rosuvastatin10mg,Ezetimibe10mg

7.0 PRINCIPAL INCLUSION CRITERIA
Inclusion criteria 40-75 years and at least one of the following risk factors: a. BMI > 7% increase or > 5kg weight gain since INSTI commencement, or b. 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
7.1 PRINCIPAL EXCLUSION CRITERIA
Exclusion criteria 1.Currently taking a protease inhibitor 2. Indicated to take or already taking high intensity statin 3. eGFR< 30 ml/min/1.73m2 4. Currently taking an SGLT-2 inhibitor or 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.
7.2 PRIMARY END POINTS
Mean reduction change in body weight (kg) across treatment arms at 24 weeks, defined as absolute body weight change. Mean change in LDL as absolute change from baseline to 24 weeks across treatment arms

9.0 DESIGN OF THE TRIAL
Type of trial	Controlled
If controlled
Randomised	Yes
Single Blind
Double Blind	Yes
Parallel group	Yes
Cross over
Other
If yes to other, specify
If controlled, specify the comparator	Placebo
Other medicinal product(s)
Placebo	Yes
Other
If yes to other, specify
Other

Expected Number of participants in Zimbabwe	30
Total enrolment in each site: (if competitive enrolment, state minimum and maximum number per site.)	30(Maximum subject enrolment may be adjusted by the Sponsor based on interim global recruitment reviews during the trial)
Total participants worldwide	300

Time period for the trial	January 2025 to June 2027

Medicines Control Authority of Zimbabwe

CT283/2024

NCT06317051

03-07-2024

Primary Sponsor Details

Secondary Sponsor Details

9.0 DESIGN OF THE TRIAL