Optimizing metabolic management on integrase-based ART (OPTIMAR): study protocol for a 2 × 2 factorial, randomised, double-blind placebo-controlled trial to compare the addition of dapagliflozin versus placebo, and rosuvastatin plus ezetimibe versus pitavastatin, in people with HIV on integrase strand transfer inhibitor-based antiretroviral therapy with elevated metabolic risk.
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| Title: | Optimizing metabolic management on integrase-based ART (OPTIMAR): study protocol for a 2 × 2 factorial, randomised, double-blind placebo-controlled trial to compare the addition of dapagliflozin versus placebo, and rosuvastatin plus ezetimibe versus pitavastatin, in people with HIV on integrase strand transfer inhibitor-based antiretroviral therapy with elevated metabolic risk. |
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| Authors: | Nyein PP; The Kirby Institute, University of New South Wales, Sydney, Australia. p.nyein@kirby.unsw.edu.au., Haskelberg H; The Kirby Institute, University of New South Wales, Sydney, Australia., Martinello M; The Kirby Institute, University of New South Wales, Sydney, Australia., Lowe M; The Kirby Institute, University of New South Wales, Sydney, Australia., Goodman-Meza D; The Kirby Institute, University of New South Wales, Sydney, Australia., Avihingsanon A; HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand., Kelleher AD; The Kirby Institute, University of New South Wales, Sydney, Australia., Rodgers A; The George Institute for Global Health, Sydney, Australia., Schutte AE; The George Institute for Global Health, Sydney, Australia., Nnakelu EC; Institute of Human Virology Nigeria (IHVN), Abuja, Nigeria., Byakwaga H; Infectious Diseases Institute (IDI), Makerere University College of Health Sciences, Kampala, Uganda., Trevillyan J; Austin Health, Melbourne, Australia., Losso M; Hospital General de Agudos J.M. Ramos Mejía, Buenos Aires, Argentina., Kumarasamy N; Chennai Antiviral Research and Treatment Clinical Research Site (CART CRS), Chennai, India., Azwa RISR; University of Malaya, Kuala Lumpur, Malaysia., Kaplan R; Desmond Tutu HIV Centre, Institute of Infectious Disease & Molecular Medicine, University of Cape Town, Cape Town, South Africa., Clifton B; National Association of People With HIV Australia (NAPWHA), Sydney, Australia., Arnott C; The George Institute for Global Health, Sydney, Australia., Dharan NJ; The Kirby Institute, University of New South Wales, Sydney, Australia., Petoumenos K; The Kirby Institute, University of New South Wales, Sydney, Australia., Matthews GV; The Kirby Institute, University of New South Wales, Sydney, Australia. Gmatthews@kirby.unsw.edu.au. |
| Source: | Trials [Trials] 2026 Apr 29; Vol. 27 (1). Date of Electronic Publication: 2026 Apr 29. |
| Publication Type: | Journal Article; Clinical Trial Protocol |
| Journal Info: | Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
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