Researchers initiate ARRIVE study for HIV-associated lipodystrophy, NAFLD
Galmed Pharmaceuticals announced the first patient has been randomized in its ARRIVE study, a clinical trial assessing the efficacy of aramchol for the treatment of nonalcoholic fatty liver disease and HIV-associated lipodystrophy, according to a press release from the manufacturer.
The ARRIVE trial will be led by Rohit Loomba, MD, MHSc, director of the NAFLD Translational Research Unit, University of California San Diego, and include 50 patients with HIV-associated lipodystrophy and NAFLD who will be randomly assigned placebo or 600 mg of aramchol (Galmed Pharmaceuticals), a conjugate of cholic acid and arachidic acid, for 12 weeks. The primary endpoint of the research is improved hepatic steatosis as measured on MRI.
“The ARRIVE Study is a prime example of [our] innovative team science approach as it brings together clinicians working on liver disease, [MRI], body composition and HIV to help solve the understudied and underappreciated issue of HIV-associated NAFLD and lipodystrophy,” Loomba said in the release.
The release stated that the rate of NAFLD is greater in patients with HIV compared with the general population. In a recent study, the largest to date, researchers including Loomba and other colleagues at the University of California San Diego, compared patients with NAFLD with patients with HIV-associated NAFLD. Data showed that patients with HIV-associated NAFLD had higher rates of definite steatohepatitis (P = 0.04), and more features of liver injury, including lobular inflammation (P < .001) and acidophil bodies (P < .001), compared with patients with NAFLD alone, according to the release.
The FDA granted fast track designation to aramchol in September 2014.
Disclosure: Healio.com/Hepatology was unable to confirm relevant financial disclosures of Loomba at the time of publication.