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We evaluated the effect on the HIV reservoir in peripheral blood and ileum biopsies in patients switching from boosted protease inhibitor (PI\/r)\u2013based therapy to dolutegravir (DTG)\u2013based therapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Impact of Integrase-inhibitor DOlutegravir On the viral Reservoir (INDOOR) is a phase 4 open-label clinical trial that randomly included 42 HIV type 1\u2013infected individuals on effective cART: 20 who switched from PI\/r-based to DTG-based cART (switch group), and 22 who remained in PI\/r-based regimens (control group). We analyzed blood and ileum biopsies to quantify episomal, total, and integrated HIV DNA, cell-associated HIV RNA, residual plasma viremia, T-cell subsets, cell activation, and inflammation markers.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>There were no related adverse events or treatment discontinuations due to drug intolerance. The HIV reservoir was consistently larger in ileal than in peripheral CD4+ T cells in both groups (P &lt; .01). Residual viremia in plasma decreased in the switch group (P = .03). However, we did not observe significant longitudinal changes in low-level viral replication, total and integrated HIV reservoir, HIV transcription, T-cell maturation subsets, immunoactivation markers, inflammatory soluble proteins, or cellular markers of latently infected cells.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The INDOOR study is the first evaluation of changes in HIV reservoir size in ileum biopsies and in peripheral blood in individuals switched from PI\/r- to DTG-based cART. Although this switch was safe and well tolerated, it had no impact on a large array of immunological and inflammatory markers or on HIV reservoir markers in peripheral or in ileal CD4+ T cells.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical Trials Registration<\/jats:title><jats:p>EudraCT 2014-004331-39.<\/jats:p><\/jats:sec>","DOI":"10.1093\/cid\/ciy1095","type":"journal-article","created":{"date-parts":[[2018,12,21]],"date-time":"2018-12-21T13:50:25Z","timestamp":1545400225000},"page":"1320-1328","source":"Crossref","is-referenced-by-count":26,"title":["Switching From a Protease Inhibitor\u2013based Regimen to a Dolutegravir-based Regimen: A Randomized Clinical Trial to Determine the Effect on Peripheral Blood and Ileum Biopsies From Antiretroviral Therapy\u2013suppressed Human Immunodeficiency Virus\u2013infected Individuals"],"prefix":"10.1093","volume":"69","author":[{"given":"Sara","family":"Mor\u00f3n-L\u00f3pez","sequence":"first","affiliation":[{"name":"AIDS Research 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Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V\u00edctor","family":"Urrea","sequence":"additional","affiliation":[{"name":"AIDS Research Institute IrsiCaixa, Badalona"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria C","family":"Puertas","sequence":"additional","affiliation":[{"name":"AIDS Research Institute IrsiCaixa, Badalona"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ariadna","family":"Torrella","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Hospital Universitari Vall d\u2019Hebron"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"De Clercq","sequence":"additional","affiliation":[{"name":"Human Immunodeficiency Virus Cure Research Center, Department of Internal Medicine, Faculty of Medicine and Health Sciences, Ghent University and Ghent University Hospital, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bibiana Planas","family":"Ribas","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Hospital Universitari Vall d\u2019Hebron"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"G\u00e1lvez","sequence":"additional","affiliation":[{"name":"AIDS Research Institute IrsiCaixa, Badalona"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Salgado","sequence":"additional","affiliation":[{"name":"AIDS Research Institute IrsiCaixa, Badalona"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linos","family":"Vandekerckhove","sequence":"additional","affiliation":[{"name":"Human Immunodeficiency Virus Cure Research Center, Department of Internal Medicine, Faculty of Medicine and Health Sciences, Ghent University and Ghent University Hospital, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juli\u00e0","family":"Blanco","sequence":"additional","affiliation":[{"name":"AIDS 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