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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.
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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  Data: 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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  Data: <searchLink fieldCode="AU" term="%22Nyein+PP%22">Nyein PP</searchLink>; The Kirby Institute, University of New South Wales, Sydney, Australia. p.nyein@kirby.unsw.edu.au.<br /><searchLink fieldCode="AU" term="%22Haskelberg+H%22">Haskelberg H</searchLink>; The Kirby Institute, University of New South Wales, Sydney, Australia.<br /><searchLink fieldCode="AU" term="%22Martinello+M%22">Martinello M</searchLink>; The Kirby Institute, University of New South Wales, Sydney, Australia.<br /><searchLink fieldCode="AU" term="%22Lowe+M%22">Lowe M</searchLink>; The Kirby Institute, University of New South Wales, Sydney, Australia.<br /><searchLink fieldCode="AU" term="%22Goodman-Meza+D%22">Goodman-Meza D</searchLink>; The Kirby Institute, University of New South Wales, Sydney, Australia.<br /><searchLink fieldCode="AU" term="%22Avihingsanon+A%22">Avihingsanon A</searchLink>; HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.<br /><searchLink fieldCode="AU" term="%22Kelleher+AD%22">Kelleher AD</searchLink>; The Kirby Institute, University of New South Wales, Sydney, Australia.<br /><searchLink fieldCode="AU" term="%22Rodgers+A%22">Rodgers A</searchLink>; The George Institute for Global Health, Sydney, Australia.<br /><searchLink fieldCode="AU" term="%22Schutte+AE%22">Schutte AE</searchLink>; The George Institute for Global Health, Sydney, Australia.<br /><searchLink fieldCode="AU" term="%22Nnakelu+EC%22">Nnakelu EC</searchLink>; Institute of Human Virology Nigeria (IHVN), Abuja, Nigeria.<br /><searchLink fieldCode="AU" term="%22Byakwaga+H%22">Byakwaga H</searchLink>; Infectious Diseases Institute (IDI), Makerere University College of Health Sciences, Kampala, Uganda.<br /><searchLink fieldCode="AU" term="%22Trevillyan+J%22">Trevillyan J</searchLink>; Austin Health, Melbourne, Australia.<br /><searchLink fieldCode="AU" term="%22Losso+M%22">Losso M</searchLink>; Hospital General de Agudos J.M. Ramos Mejía, Buenos Aires, Argentina.<br /><searchLink fieldCode="AU" term="%22Kumarasamy+N%22">Kumarasamy N</searchLink>; Chennai Antiviral Research and Treatment Clinical Research Site (CART CRS), Chennai, India.<br /><searchLink fieldCode="AU" term="%22Azwa+RISR%22">Azwa RISR</searchLink>; University of Malaya, Kuala Lumpur, Malaysia.<br /><searchLink fieldCode="AU" term="%22Kaplan+R%22">Kaplan R</searchLink>; Desmond Tutu HIV Centre, Institute of Infectious Disease & Molecular Medicine, University of Cape Town, Cape Town, South Africa.<br /><searchLink fieldCode="AU" term="%22Clifton+B%22">Clifton B</searchLink>; National Association of People With HIV Australia (NAPWHA), Sydney, Australia.<br /><searchLink fieldCode="AU" term="%22Arnott+C%22">Arnott C</searchLink>; The George Institute for Global Health, Sydney, Australia.<br /><searchLink fieldCode="AU" term="%22Dharan+NJ%22">Dharan NJ</searchLink>; The Kirby Institute, University of New South Wales, Sydney, Australia.<br /><searchLink fieldCode="AU" term="%22Petoumenos+K%22">Petoumenos K</searchLink>; The Kirby Institute, University of New South Wales, Sydney, Australia.<br /><searchLink fieldCode="AU" term="%22Matthews+GV%22">Matthews GV</searchLink>; The Kirby Institute, University of New South Wales, Sydney, Australia. Gmatthews@kirby.unsw.edu.au.
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