Evidence map›Paper›PMID 42050587›Full record

ArticleTrials2026

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.

Phyo Pyae Nyein, Hila Haskelberg, Marianne Martinello, Margaret Lowe, David Goodman-Meza, Anchalee Avihingsanon, Anthony D Kelleher, Anthony Rodgers, Aletta E Schutte, Eriobu Chukwudalu Nnakelu and 11 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06317051 (A Phase III/IV Factorial Randomized Double-blind Trial to Compare the Addition of Dapagliflozin vs Placebo and Rosuvastatin/Ezetimibe Versus Pitavastatin in Patients With HIV on Integrase Strand Transfer Inhibitor-based Antiretrovirals With Elevated Metabolic Risk), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06317051 phase3active not recruitingnot on this map

A Phase III/IV Factorial Randomized Double-blind Trial to Compare the Addition of Dapagliflozin vs Placebo and Rosuvastatin/Ezetimibe Versus Pitavastatin in Patients With HIV on Integrase Strand Transfer Inhibitor-based Antiretrovirals With Elevated Metabolic Risk

TypeinterventionalSponsorKirby InstituteRan2024 to 2027Enrolled300ConditionsHIV Infections, Weight GainArmsDapagliflozin 10mg Tab, Pitavastatin 4 Mg Oral Tablet, Rosuvastatin and Ezetimibe, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Phyo Pyae NyeinThe Kirby Institute, University of New South Wales, Sydney, Australia. p.nyein@kirby.unsw.edu.au.
Hila HaskelbergThe Kirby Institute, University of New South Wales, Sydney, Australia.
Marianne MartinelloThe Kirby Institute, University of New South Wales, Sydney, Australia.
Margaret LoweThe Kirby Institute, University of New South Wales, Sydney, Australia.
David Goodman-MezaThe Kirby Institute, University of New South Wales, Sydney, Australia.
Anchalee AvihingsanonHIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.
Anthony D KelleherThe Kirby Institute, University of New South Wales, Sydney, Australia.
Anthony RodgersThe George Institute for Global Health, Sydney, Australia.
Aletta E SchutteThe George Institute for Global Health, Sydney, Australia.
Eriobu Chukwudalu NnakeluInstitute of Human Virology Nigeria (IHVN), Abuja, Nigeria.
Helen ByakwagaInfectious Diseases Institute (IDI), Makerere University College of Health Sciences, Kampala, Uganda.
Janine TrevillyanAustin Health, Melbourne, Australia.
Marcelo LossoHospital General de Agudos J.M. Ramos Mejía, Buenos Aires, Argentina.
Nagalingeswaran KumarasamyChennai Antiviral Research and Treatment Clinical Research Site (CART CRS), Chennai, India.
Raja Iskandar Shah Raja AzwaUniversity of Malaya, Kuala Lumpur, Malaysia.
Richard KaplanDesmond Tutu HIV Centre, Institute of Infectious Disease & Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Brent CliftonNational Association of People With HIV Australia (NAPWHA), Sydney, Australia.
Clare ArnottThe George Institute for Global Health, Sydney, Australia.
Nila J DharanThe Kirby Institute, University of New South Wales, Sydney, Australia.
Kathy PetoumenosThe Kirby Institute, University of New South Wales, Sydney, Australia.
Gail V MatthewsThe Kirby Institute, University of New South Wales, Sydney, Australia. Gmatthews@kirby.unsw.edu.au.ORCID http://orcid.org/0000-0002-1048-6396

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPeople with HIV have an increased cardiovascular disease (CVD) risk due to both HIV and adverse effects of treatments. The currently preferred class of anti-retroviral drugs, integrase strand transfer inhibitors (INSTIs), has variably been linked to higher CVD risk and weight gain. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce CVD events and heart failure hospitalisations in people with or without type 2 diabetes, while also reducing weight and blood pressure, but have not been studied in people with HIV. Pitavastatin lowers CVD events in those with HIV, although it is not widely available.

methodsOPTIMAR is a 2 × 2 factorial, randomised, placebo-controlled, double-blind, phase III/IV trial and will examine the efficacy and safety of dapagliflozin 10 mg versus placebo on metabolic parameters and of rosuvastatin 10 mg + ezetimibe 10 mg versus pitavastatin 4 mg. A cardiac substudy will determine the effect of dapagliflozin versus placebo on epicardial adipose tissue (EAT) volume and coronary plaque characteristics. Virologically suppressed individuals with HIV on INSTI-based ART aged 40-75 years who had a significant weight gain after starting INSTI or BMI ≥ 30 kg/m DISCUSSION: OPTIMAR is the first trial to investigate the use of SGLT2i as a cardiometabolic intervention in people with HIV. Demonstrating favourable cardiometabolic effects of SGLT2i will introduce an innovative approach to primary CVD prevention in this at-risk population and support conducting larger trials evaluating clinical endpoints including major adverse cardiovascular events. If the combination of rosuvastatin and ezetimibe is found to be similar or superior to pitavastatin, this will inform a more feasible lipid management approach for people with HIV internationally, especially in resource-limited settings. The cardiac sub-study will further clarify the cardioprotective role of SGLT2i and provide mechanistic insights.

trial registrationClinicalTrials.gov, NCT06317051 ( https://clinicaltrials.gov/study/NCT06317051?cond=HIV&intr=Dapagliflozin&aggFilters=status:not%20rec&rank=2 ). Registration on 21 February 2024.

Indexed as

Cardiovascular DiseasesHIV InfectionsHIV Integrase InhibitorsHydroxymethylglutaryl-CoA Reductase InhibitorsSodium-Glucose Transporter 2 InhibitorsBenzhydryl CompoundsClinical Trials, Phase III as TopicClinical Trials, Phase IV as TopicDouble-Blind MethodDrug Therapy, CombinationEzetimibeGlucosidesHumansQuinolinesRandomized Controlled Trials as TopicRosuvastatin CalciumBenzhydryl CompoundsdapagliflozinEzetimibeGlucosidesHIV Integrase InhibitorsHydroxymethylglutaryl-CoA Reductase InhibitorspitavastatinQuinolinesRosuvastatin CalciumSodium-Glucose Transporter 2 InhibitorsDapagliflozinDolutegravirEzetimibeHIVHIV integrase inhibitorsPitavastatinRandomised controlled trialRosuvastatinSGLT2i

Identifiers

PMID42050587
PMCPMC13270918

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.