Aramchol for HIV-associated Nonalcoholic Fatty Liver Disease and Lipodystrophy

Phase 2 Completed 50 enrolled University of California, San Diego

RandomizedParallel-groupTriple-blindTreatment

Summary

A subset of patients with NAFLD that have not been extensively studied are those infected with human immunodeficiency virus (HIV). Currently, there is no FDA approved treatment for NAFLD or NASH. Additionally, there have been no significant clinical trials for HIV patients with NAFLD and there are no approved treatment options. We plan to conduct a randomized, double-blinded, placebo-controlled clinical trial to examine the efficacy of 600 mg of Aramchol daily (including 200 mg tablet and 400 mg tablet) versus identical placebo given over 12 weeks to improve HIV-associated hepatic steatosis as measured by a validated and accurate magnetic resonance imaging (MRI)-based technique.

Timeline

Start: 2016-01
Primary completion: 2018-02
Completion: 2018-02

Outcome

Missed primary endpoint

paper 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). PMID 31013363 ↗

paper Conclusion: Aramchol, over a 12-week period, did not reduce hepatic fat or change body fat and muscle composition PMID 31013363 ↗

Publications

Ajmera VH, Cachay E, Ramers C, Vodkin I, Bassirian S, Singh S, Mangla N, Bettencourt R, Aldous JL, Park D, Lee D, Blanchard J, Mamidipalli A, Boehringer A, Aslam S, Leinhard OD, Richards L, Sirlin C, Loomba R. MRI Assessment of Treatment Response in HIV-associated NAFLD: A Randomized Trial of a Stearoyl-Coenzyme-A-Desaturase-1 Inhibitor (ARRIVE Trial). Hepatology. 2019 Nov;70(5):1531-1545. doi: 10.1002/hep.30674. Epub 2019 Jun 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aramchol	Other / unclassified	600 mg	Oral