A Phase III/IV factorial randomized double-blind trial to compare the addition of dapagliflozin versus placebo, and rosuvastatin/ezetimibe versus pitavastatin, inpatients with HIV on integrase strand transfer inhibitor-based antiretroviral therapy with elevated metabolic risk (the OPTIMAR study).

People with HIV have an increased cardiovascular disease (CVD) risk compared to the general population due to HIV and treatment effects. Preferred HIV treatments, Integrase strand transfer inhibitors (INSTIs), are linked to higher CVD and metabolic concerns, including weight gain and elevations in blood pressure. Sodium-glucose cotransporter 2 (SGLT2) inhibitors have shown to reduce CVD events and heart failure hospitalisations in people with or without type 2 diabetes, while also reducing weight and blood pressure. Pitavastatin has also been shown to lower CVD events in those with HIV, although it is not widely available. The benefit of pitavastatin is likely a class effect of statins, although this remains unproven. The overall objective of the study is to examine the impact of dapagliflozin vs. placebo on metabolic parameters in PWH with high metabolic risk who are on INSTI-based ART.

Academic Trial

As per CDSCO’s New Drugs and Clinical Trial Rules 2019,  if the Ethics Committee has granted approval for conduct of academic clinical trial of a permitted drug formulation for a new indication or new route of administration or new dose or new dosage form and the drug is to be imported for conducting the academic clinical trial in accordance with Rule 28 of the said Rules, no import license is required from CDSCO.

Rule 28. Academic clinical trial.― (1) No permission for conducting an academic clinical trial shall be required for any drug from the Central Licencing Authority where,― (i) the clinical trial in respect of the permitted drug formulation is intended solely for academic research purposes for a new indication or new route of administration or new dose or new dosage form; and (ii) the clinical trial referred to in clause (i) has been initiated after prior approval by the Ethics Committee for clinical trial; and (iii) the observations generated from such clinical trial are not required to be submitted to the Central Licencing Authority; and (iv) the observations of such clinical trial are not used for promotional purposes.