FATTY LIVER DISEASE IN HIV

• Research type

  Research Study

• Full title

  Examining the role of gut mucosal integrity and bacterial translocation in the development and progression of Non-Alcoholic Fatty Liver Disease (NAFLD) in HIV

• IRAS ID

  190653

• Contact name

  Mark Thursz

• Contact email

  m.thursz@imperial.ac.uk

• Sponsor organisation

  Joint Research Compliance Office, Imperial College London

• Duration of Study in the UK

  3 years, 0 months, 0 days

• Research summary

  Non alcoholic fatty liver disease (NAFLD) is the most common liver disease worldwide. About 30% of patients with NAFLD will progress to develop non alcoholic steatohepatitis (NASH), with increased risk of liver fibrosis, cirrhosis and hepatocellular carcinoma (HCC). In the general population NAFLD is associated with the metabolic syndrome, including diabetes, insulin resistance and obesity.

  As treatment for HIV has improved with highly active antiretroviral therapy (HART), it has become a chronic disease complicated by complex co-morbidities including liver disease. There is an increased incidence and severity of NAFLD in HIV infected patients. This is associated with the metabolic syndrome as in the general population, but there are also recognised associations with antiretrovirals and lipodystrophy.

  We hypothesise that the increased intestinal permeability and bacterial translocation demonstrated in HIV infection may be a mechanism for the presence and severity of NAFLD and NASH.

  This study will involve the collection of blood, urine and stool samples to identify immunological and microbiome biomarkers from 6 groups of patients:
  1. HIV-infected controls without known liver disease
  2. HIV-infected controls with simple steatosis
  3. HIV-infected controls with NASH
  4. HIV-negative patients with simple steatosis
  5. HIV-negative patients with NASH
  6. Healthy controls without liver disease or blood borne viruses

  The patients will be identified through the HIV and hepatology clinics at St Mary’s and Chelsea & Westminster Hospitals. Eligible patients will be invited to attend the hepatology department for a single clinical assessment and to have samples of collected. Participant demographic information, laboratory results and clinical history will be obtained from the hospital records.

  Participants will be enrolled over a period of two years.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  15/LO/1999

• Date of REC Opinion

  9 Dec 2015

• REC opinion

  Favourable Opinion