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MRI Assessment of T...
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Ajmera, Veeral H.Univ Calif San Diego Hlth, CA USA
(author)
MRI Assessment of Treatment Response in HIV-associated NAFLD: A Randomized Trial of a Stearoyl-Coenzyme-A-Desaturase-1 Inhibitor (ARRIVE Trial)
- Article/chapterEnglish2019
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2019-06-18
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WILEY,2019
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LIBRIS-ID:oai:DiVA.org:liu-162060
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https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-162060URI
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https://doi.org/10.1002/hep.30674DOI
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Language:English
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Summary in:English
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
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Funding Agencies|the John A. Hartford Foundation; GALMED; American Association for the Study of Liver Diseases Foundation Clinical and Translational Research Award; Atlantic Philanthropies, Inc.
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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) amp;gt;= 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(2), respectively. There was no difference in the reduction in mean MRI-PDFF between the aramchol group at -1.3% (baseline MRI-PDFF 15.6% versus end-of-treatment MRI-PDFF 14.4%, P = 0.24) and the placebo group at -1.4% (baseline MRI-PDFF 13.3% versus end-of-treatment MRI-PDFF 11.9%, P = 0.26). There was no difference in the relative decline in mean MRI-PDFF between the aramchol and placebo groups (6.8% versus 1.1%, P = 0.68). There were no differences in MRE-derived and VCTE-derived liver stiffness and whole-body (fat and muscle) composition analysis by MRI or DXA. Compared to baseline, end-of-treatment aminotransferases were lower in the aramchol group but not in the placebo arm. There were no significant adverse events. Conclusion: Aramchol, over a 12-week period, did not reduce hepatic fat or change body fat and muscle composition by using MRI-based assessment in patients with HIV-associated NAFLD (clinicaltrials.gov ID:NCT02684591).
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Cachay, EdwardUniv Calif San Diego, CA 92103 USA
(author)
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Ramers, ChristianFamily Hlth Ctr, CA USA
(author)
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Vodkin, IrineUniv Calif San Diego Hlth, CA USA
(author)
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Bassirian, ShirinUniv Calif San Diego Hlth, CA USA
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Singh, SeemaUniv Calif San Diego Hlth, CA USA
(author)
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Mangla, NeerajUniv Calif San Diego Hlth, CA USA
(author)
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Bettencourt, RicheleUniv Calif San Diego Hlth, CA USA
(author)
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Aldous, Jeannette L.San Ysidro Hlth, CA USA
(author)
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Park, DanielSan Ysidro Hlth, CA USA
(author)
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Lee, DanielUniv Calif San Diego, CA 92103 USA
(author)
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Blanchard, JenniferUniv Calif San Diego, CA 92103 USA
(author)
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Mamidipalli, AdrijaUniv Calif San Diego, CA 92093 USA
(author)
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Boehringer, AndrewUniv Calif San Diego, CA 92093 USA
(author)
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Aslam, SaimaUniv Calif San Diego, CA 92103 USA
(author)
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Dahlqvist Leinhard, Olof,1978-Linköpings universitet,Avdelningen för radiologiska vetenskaper,Medicinska fakulteten,Region Östergötland, Radiofysikavdelningen US,AMRA Med AB, Linkoping, Sweden(Swepub:liu)oloda24
(author)
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Richards, LisaUniv Calif San Diego Hlth, CA USA
(author)
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Sirlin, Claude B.Univ Calif San Diego, CA 92093 USA
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Loomba, RohitUniv Calif San Diego, CA 92093 USA
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Univ Calif San Diego Hlth, CA USAUniv Calif San Diego, CA 92103 USA
(creator_code:org_t)
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In:Hepatology: WILEY70:5, s. 1531-15450270-91391527-3350
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