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/m2 , 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).