Aramchol for HIV-associated Nonalcoholic Fatty Liver Disease and Lipodystrophy

Inclusion Criteria

• Age at entry at least 18 years.
• And at least one of the following risk factor for more severe liver disease: Hypertriglyceridemia based upon ATP-III guidelines, Increased LDL cholesterol or increased total cholesterol based upon ATP-III guidelines, Decreased HDL cholesterol based upon ATP-III guidelines, Serum alanine (ALT) or aspartate (AST) aminotransferase activities that are above the upper limits of normal. 19 or more in women and 30 or more in men, Overweight as defined as BMI: 25 1.4, albumin 9 or uncontrolled diabetes. 11. Significant systemic or major illnesses other than liver disease, including congestive heart failure, coronary artery disease, cerebrovascular disease, pulmonary disease with hypoxia, renal failure, organ transplantation, serious psychiatric disease, malignancy that, in the opinion of the investigator would preclude treatment with Aramchol and adequate follow up.
• Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year. 13. Pregnancy or inability to practice adequate contraception in women of childbearing potential.
• Evidence of hepatocellular carcinoma: alpha-fetoprotein levels greater than 200 ng/ml and/or liver mass on imaging study that is suggestive of liver cancer.
• HIV specific exclusions: CD4 count of less than 200 cells/μL, Detectable viral load,Changes to ART regimen in the preceding 12 weeks,Lack of alternative ART regimens should the patient experience virologic breakthrough,History of opportunistic infection in the preceding 12 months
• Symptoms of uncontrolled gastrointestinal disorders involving motility, gastric acid or gastric emptying malabsorption ,Disorders including but not limited to peptic ulcer disease, gastroesophageal reflux, dyspepsia, gastroparesis, chronic diarrhea, chromic constipation, gall bladder disease,pancreatitis, lactose intolerance and celiac disease.Patients who have used anticholinergic or other drugs known to affect gastrointestinal motility within 7 days prior to dosing and throughout the study will also be excluded
• Patients with hypersensitivity to Aramchol or to any of the excipients in the tablets or with hypersensitivity to cholic acid or bile acid sequestrants
• Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibility hinder completion of the study.