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There is an ongoing need for new antiretrovirals and treatment strategies for this population. We reviewed the study designs, baseline characteristics, and results of clinical trials that enrolled HTE persons with HIV. A PubMed literature search retrieved articles published between 1995 and 2020, which were grouped by trial start date (1995\u20132009, N = 89; 2010\u20132014, N = 3; 2015\u20132020, N = 2). Clinical trials in HTE participants markedly declined post-2010. Participant characteristics and study designs showed changes in trends over time. As treatment strategies for HTE persons with HIV progress, we must look beyond virologic suppression to consider the broader needs of this complex heterogeneous population.<\/jats:p>","DOI":"10.1177\/13596535231174774","type":"journal-article","created":{"date-parts":[[2023,5,22]],"date-time":"2023-05-22T10:12:37Z","timestamp":1684750357000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":5,"title":["The evolution of clinical study design in heavily treatment-experienced persons with HIV: A critical review"],"prefix":"10.1177","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8162-0284","authenticated-orcid":false,"given":"Judith A","family":"Aberg","sequence":"first","affiliation":[{"name":"Icahn School of Medicine at Mount Sinai, New York, NY, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anthony","family":"Mills","sequence":"additional","affiliation":[{"name":"Men\u2019s Health Foundation, Los Angeles, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Santiago","family":"Moreno","sequence":"additional","affiliation":[{"name":"Hospital Ram\u00f3n y Cajal, Universidad de Alcal\u00e1, IRYCIS, Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jill","family":"Slater","sequence":"additional","affiliation":[{"name":"ViiV Healthcare, Durham, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7643-0387","authenticated-orcid":false,"given":"Manyu","family":"Prakash","sequence":"additional","affiliation":[{"name":"ViiV Healthcare, Brentford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Clark","sequence":"additional","affiliation":[{"name":"ViiV Healthcare, Brentford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2023,5,22]]},"reference":[{"key":"bibr1-13596535231174774","unstructured":"Panel on Antiretroviral Guidelines for Adults and Adolescents. 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