OPTIMAR
Optimising metabolic management on integrase based ART
The OPTIMAR trial aims to address the increased cardiovascular risk for people with HIV due to both the infection and its treatment. Integrase strand transfer inhibitors (INSTIs), the preferred HIV treatments, have been associated with increased cardiovascular and metabolic concerns, such as weight gain and elevated blood pressure. By investigating the effects of dapagliflozin, an SGLT2 inhibitor known to reduce cardiovascular events and improve metabolic measures, OPTIMAR seeks to optimise the management of cardiovascular risk in people with HIV on INSTI-based antiretroviral therapy.
In addition, the use of more cost-effective and widely available statins like rosuvastatin and ezetimibe addresses affordability and logistical challenges in resource-limited settings. The results from this trial could lead to improved understating of treatment strategies and better health outcomes for people with HIV.
OPTIMAR uses a novel approach by evaluating dapagliflozin, an SGLT2 inhibitor, in combination with statins to address cardiovascular risks in people with HIV on INSTI-based antiretroviral therapy. This study uniquely targets weight change and improved cardiovascular profiles through a double-blind, placebo-controlled design, involving participants from both high-income and low- and middle-income countries. This collaborative effort involves multiple international sites, including Australia, Thailand, Malaysia, India, South Africa, Nigeria, Zimbabwe, Uganda and Argentina.
This project is led by Professor Gail Matthews.
The trial is a 2x2 factorial randomised placebo-controlled double-blind study with a 48-week follow-up. It involves participants with HIV on INSTI-based ART who are at high metabolic risk. Participants are randomised to receive either dapagliflozin or placebo, combined with either pitavastatin or rosuvastatin/ezetimibe. The study will assess the effects on weight and LDL cholesterol. Clinical and laboratory assessments are conducted at screening, randomisation, and follow-up visits. An independent Data Safety and Monitoring Board oversees the trial.
We expect to generate new insights into optimising cardiovascular health for people with HIV. We aim to demonstrate that dapagliflozin, combined with statins, effectively reduces cardiovascular risks and metabolic risks such as weight gain and high LDL cholesterol. The primary endpoint is at 24 weeks, with follow-up over 48 weeks. Expected outcomes include improved weight change, lipid profiles and overall cardiovascular health.
The OPTIMAR trial aims to impact global cardiovascular health for people with HIV, especially in low- and middle-income countries. By demonstrating the effectiveness of dapagliflozin and statins in reducing cardiovascular risks and metabolic concerns, this research could inform larger clinical trials and treatment strategies to improve health outcomes and reduce cardiovascular morbidity and mortality.
- The George Institute for Global Health, Australia
- Desmond Tutu HIV Foundation, South Africa
- Institute of Human Virology, Nigeria
- Infectious Diseases Institute, Uganda
- University of Zimbabwe Clinical Research Centre, Zimbabwe
- Chennai Antiviral Research and Treatment Clinical Research Site, India
- HIV-NAT/Thai Red Cross, Thailand
- University of Malaya Medical Centre (UMMC), Malaysia
- St. Vincent's Hospital, Sydney, Australia
- Hospital General de Agudos J M Ramos Mejia, Argentina
