{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,12]],"date-time":"2026-05-12T08:39:52Z","timestamp":1778575192306,"version":"3.51.4"},"reference-count":29,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2023,8,19]],"date-time":"2023-08-19T00:00:00Z","timestamp":1692403200000},"content-version":"unspecified","delay-in-days":18,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100009459","name":"Hvidovre Hospital","doi-asserted-by":"publisher","award":["2021-533"],"award-info":[{"award-number":["2021-533"]}],"id":[{"id":"10.13039\/501100009459","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100019316","name":"Simonsen Foundation","doi-asserted-by":"publisher","award":["NA - No grant number available"],"award-info":[{"award-number":["NA - No grant number available"]}],"id":[{"id":"10.13039\/100019316","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,7,13]]},"published-print":{"date-parts":[[2023,8]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>With longer life expectancy in people living with HIV (PLWH) on antiretroviral therapy, cardiovascular disease (CVD) has become a common cause of mortality among them. Abacavir has been associated with an increased risk of myocardial infarction, but the mechanism is unknown. Additionally, abacavir may be obesogenic which could mediate an additional risk factor of CVD. We aim to investigate if discontinuation of abacavir will have a favourable impact on body weight and cardiac parameters in PLWH.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>Randomised, controlled, superiority trial of virologically suppressed PLWH on dolutegravir, abacavir and lamivudine (DTG\/ABC\/3TC) for \u22656 months. In total, 70 PLWH will be randomised 1:2 to either continue DTG\/ABC\/3TC or to switch to dolutegravir and lamivudine (DTG\/3TC) providing the power of 80% at alpha 5% to detect a mean difference in weight change of 2\u2009kg (\u0394) given an SD of 2.7\u2009kg. Follow-up will be 48 weeks. Data will be collected at baseline and week 48. Primary outcome will be change in mean body weight from baseline to week 24 and 48 evaluated in a linear mixed model. Secondary outcomes will be changes in cardiac, inflammatory and metabolic parameters, fat distribution, coagulation, endothelial, platelet function, quality of life and virological control from baseline to week 48. Measurements include CT of thorax and abdomen, external carotid artery ultrasound, liver elastography and dual energy X-ray absorptiometry and blood analysis. Plasma HIV RNA will be measured at baseline, week 4, 24 and 48. Forty participants (20 from each arm) will be included in a substudy involving cardiac MRI at baseline and week 48. Twenty non-HIV-infected controls will be included with a single scan to compare with baseline scan data.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Result from this study will lead to a better understanding of the association between antiretroviral therapy and the impact on weight and risk of CVD. Findings will be useful for both clinicians and PLWH in the guidance of a more individualised HIV treatment. Results from the main study and the substudies will be submitted for publication in a peer-reviewed journal(s). The AVERTAS study is approved by the Ethics Committee of the Capital Region, Denmark (H-20011433), Danish Medicines Agency (EudraCT no. 2019-004999-19) and Regional Data Protection Centre (P-2020\u2013207).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      Pre-results registration at ClinicalTrials.gov Identifier:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04904406\">NCT04904406<\/jats:ext-link>\n                      , registered 27 May 2021. Protocol version: Protocol version 9.0, 4 April 2023, approved 10-05-2023 by Ethics Committee of the Capital Region, Denmark (H-20011433). Danish Medicines Agency (EudraCT no. 2019-004999-19). Regional Data Protection Centre (P-2020\u2013207) ClinicalTrials.gov.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-075673","type":"journal-article","created":{"date-parts":[[2023,8,21]],"date-time":"2023-08-21T12:46:12Z","timestamp":1692621972000},"page":"e075673","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Changes in weight, body composition and metabolic parameters after switch to dolutegravir\/lamivudine compared with continued treatment with dolutegravir\/abacavir\/lamivudine for virologically suppressed HIV infection (The AVERTAS trial): a randomised, open-label, superiority trial in Copenhagen, Denmark"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"nct04904406","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2501-8421","authenticated-orcid":false,"given":"Karen Brorup Heje","family":"Pedersen","sequence":"first","affiliation":[{"name":"Department of Infectious Diseases, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andreas","family":"Knudsen","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine and Infectious Diseases, Copenhagen University Hospital \u2013 Bispebjerg, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S\u00f8ren","family":"M\u00f8ller","sequence":"additional","affiliation":[{"name":"Department of Clinical Physiology and Nuclear Medicine, Center for Functional and Diagnostic Imaging and Research, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark"},{"name":"Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hartwig Roman","family":"Siebner","sequence":"additional","affiliation":[{"name":"Department of Clinical Physiology and Nuclear Medicine, Center for Functional and Diagnostic Imaging and Research, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark"},{"name":"Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark"},{"name":"Danish Research Centre for Magnetic Resonance (DRCMR), Copenhagen University Hospital Amager and Hvidovre, Hvidovre, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jens Dahlgaard","family":"Hove","sequence":"additional","affiliation":[{"name":"Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark"},{"name":"Department of Cardiology, Hvidovre Hospital, Hvidovre, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jan","family":"Gerstoft","sequence":"additional","affiliation":[{"name":"Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark"},{"name":"Department of Infectious Diseases, Copenhagen University Hospital- Rigshospitalet, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Benfield","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark"},{"name":"Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2023,8,21]]},"reference":[{"key":"2025121601274312000_13.8.e075673.1","doi-asserted-by":"crossref","first-page":"749","DOI":"10.7326\/L16-0091","article-title":"Update of survival for persons with HIV infection in Denmark","volume":"165","author":"Lohse","year":"2016","journal-title":"Ann Intern Med"},{"key":"2025121601274312000_13.8.e075673.2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-1293.2010.00824.x"},{"key":"2025121601274312000_13.8.e075673.3","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(14)60604-8"},{"key":"2025121601274312000_13.8.e075673.4","doi-asserted-by":"crossref","first-page":"614","DOI":"10.1001\/jamainternmed.2013.3728","article-title":"HIV infection and the risk of acute myocardial infarction","volume":"173","author":"Freiberg","year":"2013","journal-title":"JAMA Intern Med"},{"key":"2025121601274312000_13.8.e075673.5","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2015.10.030"},{"key":"2025121601274312000_13.8.e075673.6","doi-asserted-by":"crossref","DOI":"10.1186\/s12916-016-0588-4","article-title":"Is there continued evidence for an association between Abacavir usage and myocardial infarction risk in individuals with HIV? A cohort collaboration","volume":"14","author":"Sabin","year":"2016","journal-title":"BMC Med"},{"key":"2025121601274312000_13.8.e075673.7","doi-asserted-by":"publisher","DOI":"10.1086\/649897"},{"key":"2025121601274312000_13.8.e075673.8","doi-asserted-by":"crossref","first-page":"1417","DOI":"10.1016\/S0140-6736(08)60423-7","article-title":"Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients enrolled in the D:A:D study: a multi-cohort collaboration","volume":"371","year":"2008","journal-title":"The Lancet"},{"key":"2025121601274312000_13.8.e075673.9","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0b013e328347fa16"},{"key":"2025121601274312000_13.8.e075673.10","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/civ316"},{"key":"2025121601274312000_13.8.e075673.11","doi-asserted-by":"crossref","first-page":"861","DOI":"10.1097\/QAD.0000000000001783","article-title":"Switching from Abacavir to tenofovir disoproxil fumarate is associated with rises in soluble glycoprotein VI, suggesting changes in platelet-collagen interactions","volume":"32","author":"O\u2019Halloran","year":"2018","journal-title":"AIDS"},{"key":"2025121601274312000_13.8.e075673.12","unstructured":"EACSociety . EACS guidelines. 2019. Available: https:\/www.eacsociety.org\/guidelines\/eacs-guidelines\/eacs-guidelines.html"},{"key":"2025121601274312000_13.8.e075673.13","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2022.22246"},{"key":"2025121601274312000_13.8.e075673.14","doi-asserted-by":"crossref","first-page":"143","DOI":"10.1016\/S0140-6736(18)32462-0","article-title":"Dolutegravir plus lamivudine versus Dolutegravir plus tenofovir disoproxil fumarate and Emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two Multicentre, double-blind, randomised, non-inferiority, phase 3 trials","volume":"393","author":"Cahn","year":"2019","journal-title":"Lancet"},{"key":"2025121601274312000_13.8.e075673.15","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciz1243"},{"key":"2025121601274312000_13.8.e075673.16","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciac130"},{"key":"2025121601274312000_13.8.e075673.17","doi-asserted-by":"crossref","first-page":"975","DOI":"10.1093\/cid\/ciac036","article-title":"Efficacy and safety of switching to Dolutegravir\/lamivudine versus continuing a tenofovir Alafenamide-based 3- or 4-drug regimen for maintenance of virologic suppression in adults living with human immunodeficiency virus type 1","volume":"75","author":"Osiyemi","year":"2022","journal-title":"Clinical Infectious Diseases"},{"key":"2025121601274312000_13.8.e075673.18","doi-asserted-by":"publisher","DOI":"10.1089\/aid.2015.0147"},{"key":"2025121601274312000_13.8.e075673.19","doi-asserted-by":"crossref","first-page":"2177","DOI":"10.1093\/jac\/dky145","article-title":"Obesity following ART initiation is common and influenced by both traditional and HIV-\/ART-specific risk factors","volume":"73","author":"Bakal","year":"2018","journal-title":"J Antimicrob Chemother"},{"key":"2025121601274312000_13.8.e075673.20","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1016\/S2055-6640(20)30277-6","article-title":"Are new antiretroviral treatments increasing the risks of clinical obesity","volume":"5","author":"Hill","year":"2019","journal-title":"Journal of Virus Eradication"},{"key":"2025121601274312000_13.8.e075673.21","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciz999"},{"key":"2025121601274312000_13.8.e075673.22","doi-asserted-by":"crossref","first-page":"54","DOI":"10.24875\/AIDSRev.22000026","article-title":"Antiretroviral therapy and weight gain in antiretroviral treatment-experienced HIV patients: A review","volume":"25","author":"Dupont","year":"2023","journal-title":"AIDS Rev"},{"key":"2025121601274312000_13.8.e075673.23","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.159.18.2177"},{"key":"2025121601274312000_13.8.e075673.24","unstructured":"Consensus statements. n.d. Available: https:\/\/www.idf.org\/e-library\/consensus-statements\/60-idfconsensus-worldwide-definitionof-the-metabolic-syndrome.html"},{"key":"2025121601274312000_13.8.e075673.25","unstructured":"HEARTS D: diagnosis and management of type 2 diabetes. n.d. Available: https:\/\/www.who.int\/publications-detail-redirect\/who-ucn-ncd-20.1"},{"key":"2025121601274312000_13.8.e075673.26","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.27.6.1487"},{"key":"2025121601274312000_13.8.e075673.27","unstructured":"2018 prevention guidelines tool CV risk Calculator. n.d. Available: http:\/\/static.heart.org\/riskcalc\/app\/index.html#!\/baseline-risk"},{"key":"2025121601274312000_13.8.e075673.28","unstructured":"Framingham heart study. 2019. Available: https:\/\/www.framinghamheartstudy.org\/fhs-risk-functions\/cardiovascular-disease-10-year-risk\/"},{"key":"2025121601274312000_13.8.e075673.29","unstructured":"CHIP . Centre of excellence for health, immunity and infections. n.d. Available: https:\/\/chip.dk\/Tools-Standards\/Clinical-risk-scores"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2023-075673","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T09:27:54Z","timestamp":1765877274000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2023-075673"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,8]]},"references-count":29,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2023,8,21]]},"published-print":{"date-parts":[[2023,8]]}},"alternative-id":["10.1136\/bmjopen-2023-075673"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2023-075673","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,8]]}}}