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Switching From a Protease Inhibitor-based Regimen to a Dolutegravir-based Regimen : A Randomized Clinical Trial to Determine the Effect on Peripheral Blood and Ileum Biopsies From Antiretroviral Therapy-suppressed Human Immunodeficiency Virus-infected Individuals
Morón-López, Sara (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Navarro, Jordi (Institut de Recerca Vall d'Hebron)
Jimenez, Montse (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Rutsaert, Sofie (Human Immunodeficiency Virus Cure Research Center, Department of Internal Medicine, Faculty of Medicine and Health Sciences, Ghent University and Ghent University Hospital)
Urrea, Víctor (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Puertas, Maria C (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Torrella, Ariadna (Hospital Universitari Vall d'Hebron)
De Clercq, Laura (Human Immunodeficiency Virus Cure Research Center, Department of Internal Medicine, Faculty of Medicine and Health Sciences, Ghent University and Ghent University Hospital)
Ribas, Bibiana Planas (,Hospital Universitari Vall d'Hebron)
Gálvez, Cristina (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Salgado, Maria (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Vandekerckhove, Linos (Human Immunodeficiency Virus Cure Research Center, Department of Internal Medicine, Faculty of Medicine and Health Sciences, Ghent University and Ghent University Hospital)
Blanco, Julià (University of Vic-Central University of Catalonia)
Crespo, Manel (Infectious Diseases Unit, Internal Medicine Department, Complexo Hospitalario Universitario de Vigo, Instituto de Investigación Sanitaria Galicia Sur)
Martinez-Picado, Javier (Catalan Institution for Research and Advanced Studies)
Universitat Autònoma de Barcelona

Date: 2018
Abstract: Optimization of combination antiretroviral therapy (cART) can impact the human immunodeficiency virus (HIV) reservoir. We evaluated the effect on the HIV reservoir in peripheral blood and ileum biopsies in patients switching from boosted protease inhibitor (PI/r)-based therapy to dolutegravir (DTG)-based therapy. 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-infected 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. 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 <. 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. 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. EudraCT 2014-004331-39. INDOOR evaluated the effect of switching from boosted protease inhibitor- to dolutegravir-based antiretroviral therapy on the HIV reservoir in peripheral blood and ileum. Residual plasma viremia and soluble CD14 levels decreased, but low-level HIV replication, the HIV reservoir, and immune activation remained unaffected.
Note: Número d'acord de subvenció MINECO/FPDI-2013-17134
Note: Número d'acord de subvenció AGAUR/2013FI_B00275
Note: Número d'acord de subvenció MECD/FPU15/03698
Rights: Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades. Creative Commons
Language: Anglès.
Document: article ; recerca ; publishedVersion
Subject: Switching ; Dolutegravir ; HIV reservoir ; Ileum biopsies ; Immunological and inflammation markers
Published in: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America, Vol. 69 (december 2018) , p. 1320-1328, ISSN 1537-6591

PMID: 30590412
DOI: 10.1093/cid/ciy1095


9 p, 1.7 MB

The record appears in these collections:
Research literature > UAB research groups literature > Research Centres and Groups (scientific output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Articles > Research articles
Articles > Published articles

 Record created 2019-10-07, last modified 2020-02-08



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