MRI Assessment of Treatment Response in HIV-associated NAFLD: A Randomized Trial of a Stearoyl-Coenzyme-A-Desaturase-1 Inhibitor (ARRIVE Trial).
Journal
Hepatology (Baltimore, Md.)
ISSN: 1527-3350
Titre abrégé: Hepatology
Pays: United States
ID NLM: 8302946
Informations de publication
Date de publication:
11 2019
11 2019
Historique:
received:
04
01
2019
accepted:
01
04
2019
pubmed:
24
4
2019
medline:
3
7
2020
entrez:
24
4
2019
Statut:
ppublish
Résumé
Aramchol, an oral stearoyl-coenzyme-A-desaturase-1 inhibitor, has been shown to reduce hepatic fat content in patients with primary nonalcoholic fatty liver disease (NAFLD); however, its effect in patients with human immunodeficiency virus (HIV)-associated NAFLD is unknown. The aramchol for HIV-associated NAFLD and lipodystrophy (ARRIVE) trial was a double-blind, randomized, investigator-initiated, placebo-controlled trial to test the efficacy of 12 weeks of treatment with aramchol versus placebo in HIV-associated NAFLD. Fifty patients with HIV-associated NAFLD, defined by magnetic resonance imaging (MRI)-proton density fat fraction (PDFF) ≥5%, were randomized to receive either aramchol 600 mg daily (n = 25) or placebo (n = 25) for 12 weeks. The primary endpoint was a change in hepatic fat as measured by MRI-PDFF in colocalized regions of interest. Secondary endpoints included changes in liver stiffness using magnetic resonance elastography (MRE) and vibration-controlled transient elastography (VCTE), and exploratory endpoints included changes in total-body fat and muscle depots on dual-energy X-ray absorptiometry (DXA), whole-body MRI, and cardiac MRI. The mean (± standard deviation) of age and body mass index were 48.2 ± 10.3 years and 30.7 ± 4.6 kg/m
Identifiants
pubmed: 31013363
doi: 10.1002/hep.30674
pmc: PMC7164416
mid: NIHMS1579290
doi:
Substances chimiques
Cholic Acids
0
aramchol
QE1Q24M65Y
Banques de données
ClinicalTrials.gov
['NCT02684591']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1531-1545Subventions
Organisme : NIDDK NIH HHS
ID : K23 DK119460
Pays : United States
Organisme : Atlantic Philanthropies, Inc.
Pays : International
Organisme : GALMED
Pays : International
Organisme : American Association for the Study of Liver Diseases' Foundation Clinical and Translational Research Award
Pays : International
Organisme : the John A. Hartford Foundation
Pays : International
Organisme : NIDDK NIH HHS
ID : R01 DK106419
Pays : United States
Informations de copyright
© 2019 by the American Association for the Study of Liver Diseases.
Références
Gastroenterology. 2018 Aug;155(2):307-310.e2
pubmed: 29660324
Aliment Pharmacol Ther. 2015 Feb;41(4):368-78
pubmed: 25496369
J Magn Reson Imaging. 2011 Oct;34(4):729-749
pubmed: 22025886
Am J Gastroenterol. 2014 May;109(5):695-704
pubmed: 24642579
Hepatology. 2018 Apr;67(4):1348-1359
pubmed: 29108123
Clin Gastroenterol Hepatol. 2019 Mar;17(4):630-637.e8
pubmed: 29908362
Gastroenterology. 2018 Nov;155(5):1463-1473.e6
pubmed: 30059671
Hepatology. 2012 Sep;56(3):922-32
pubmed: 22431131
Gastroenterology. 2016 May;150(5):1147-1159.e5
pubmed: 26874076
Gastroenterology. 2016 Mar;150(3):626-637.e7
pubmed: 26677985
Eur J Gastroenterol Hepatol. 2003 Jun;15(6):649-55
pubmed: 12840677
J Acquir Immune Defic Syndr. 2007 Aug 1;45(4):432-8
pubmed: 17558337
Radiology. 2017 May;283(2):438-449
pubmed: 28278002
Am J Pathol. 2008 Jun;172(6):1580-90
pubmed: 18467708
AIDS. 2002 Mar 29;16(5):F1-8
pubmed: 11964551
J Acquir Immune Defic Syndr. 2013 Dec 15;64(5):425-33
pubmed: 23797689
J Hepatol. 2018 Feb;68(2):296-304
pubmed: 29203392
AIDS. 2016 Nov 28;30(18):2805-2813
pubmed: 27662545
Hepatology. 2016 Jul;64(1):73-84
pubmed: 26707365
AIDS. 2017 Jul 17;31(11):1621-1632
pubmed: 28398960
Hepatology. 2018 May;67(5):1754-1767
pubmed: 28833331
J Infect Dis. 2015 Jan 1;211(1):19-27
pubmed: 25057045
Hepatology. 2013 Dec;58(6):1930-40
pubmed: 23696515
NMR Biomed. 2015 Dec;28(12):1747-53
pubmed: 26768490
Arch Intern Med. 2006 Aug 14-28;166(15):1632-41
pubmed: 16908797
Aliment Pharmacol Ther. 2012 Jul;36(1):22-9
pubmed: 22554256
J Hepatol. 2008 May;48(5):835-47
pubmed: 18334275
Hepatology. 2018 Aug;68(2):763-772
pubmed: 29356032
Radiology. 2013 May;267(2):422-31
pubmed: 23382291
Clin Gastroenterol Hepatol. 2014 Dec;12(12):2085-91.e1
pubmed: 24815326
J Am Coll Cardiol. 2013 Apr 2;61(13):1388-95
pubmed: 23433560
Gastroenterology. 2015 Dec;149(7):1784-93
pubmed: 26299412
Gut. 2016 Sep;65(9):1546-54
pubmed: 26002934
Dig Liver Dis. 2018 Apr;50(4):389-395
pubmed: 29373238
Ultrasound Med Biol. 2003 Dec;29(12):1705-13
pubmed: 14698338
Hepatology. 2018 Feb;67(2):549-559
pubmed: 28892558
Nat Rev Gastroenterol Hepatol. 2013 Nov;10(11):686-90
pubmed: 24042449
Int J Cardiol. 2018 Jun 1;260:204-210
pubmed: 29622443
Obesity (Silver Spring). 2018 Nov;26(11):1785-1795
pubmed: 29785727
Hepatology. 2015 Apr;61(4):1239-50
pubmed: 25482832
Circulation. 2003 Nov 18;108(20):2460-6
pubmed: 14581396
Aliment Pharmacol Ther. 2013 Mar;37(6):630-9
pubmed: 23383649
Gastroenterology. 2017 Feb;152(3):598-607.e2
pubmed: 27911262
Clin Infect Dis. 2015 May 15;60(10):1569-78
pubmed: 25681381
J Hepatol. 2016 Aug;65(2):369-76
pubmed: 27151177