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MRI Assessment of T...
MRI Assessment of Treatment Response in HIV-associated NAFLD: A Randomized Trial of a Stearoyl-Coenzyme-A-Desaturase-1 Inhibitor (ARRIVE Trial)
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- Ajmera, Veeral H. (author)
- Univ Calif San Diego Hlth, CA USA
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- Cachay, Edward (author)
- Univ Calif San Diego, CA 92103 USA
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- Ramers, Christian (author)
- Family Hlth Ctr, CA USA
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- Vodkin, Irine (author)
- Univ Calif San Diego Hlth, CA USA
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- Bassirian, Shirin (author)
- Univ Calif San Diego Hlth, CA USA
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- Singh, Seema (author)
- Univ Calif San Diego Hlth, CA USA
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- Mangla, Neeraj (author)
- Univ Calif San Diego Hlth, CA USA
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- Bettencourt, Richele (author)
- Univ Calif San Diego Hlth, CA USA
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- Aldous, Jeannette L. (author)
- San Ysidro Hlth, CA USA
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- Park, Daniel (author)
- San Ysidro Hlth, CA USA
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- Lee, Daniel (author)
- Univ Calif San Diego, CA 92103 USA
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- Blanchard, Jennifer (author)
- Univ Calif San Diego, CA 92103 USA
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- Mamidipalli, Adrija (author)
- Univ Calif San Diego, CA 92093 USA
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- Boehringer, Andrew (author)
- Univ Calif San Diego, CA 92093 USA
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- Aslam, Saima (author)
- Univ Calif San Diego, CA 92103 USA
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- Dahlqvist Leinhard, Olof, 1978- (author)
- Linköpings universitet,Avdelningen för radiologiska vetenskaper,Medicinska fakulteten,Region Östergötland, Radiofysikavdelningen US,AMRA Med AB, Linkoping, Sweden
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- Richards, Lisa (author)
- Univ Calif San Diego Hlth, CA USA
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- Sirlin, Claude B. (author)
- Univ Calif San Diego, CA 92093 USA
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- Loomba, Rohit (author)
- Univ Calif San Diego, CA 92093 USA
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(creator_code:org_t)
- 2019-06-18
- 2019
- English.
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In: Hepatology. - : WILEY. - 0270-9139 .- 1527-3350. ; 70:5, s. 1531-1545
- Related links:
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https://www.ncbi.nlm...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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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).
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Gastroenterologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Gastroenterology and Hepatology (hsv//eng)
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Hepatology
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Ajmera, Veeral H ...
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Cachay, Edward
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Ramers, Christia ...
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Vodkin, Irine
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Bassirian, Shiri ...
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Singh, Seema
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Mangla, Neeraj
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Bettencourt, Ric ...
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Aldous, Jeannett ...
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Park, Daniel
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Lee, Daniel
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Blanchard, Jenni ...
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Mamidipalli, Adr ...
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Boehringer, Andr ...
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Aslam, Saima
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Dahlqvist Leinha ...
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Richards, Lisa
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Sirlin, Claude B ...
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Loomba, Rohit
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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Hepatology
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Linköping University