Clinical trial NCT03913351: Lifestyle Modification Programme for HIV-infected Individuals With Fatty Liver
Official title: Lifestyle Modification Programme for HIV-infected Individuals With Non-alcoholic Fatty Liver Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: NAFLD
Hiv
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-04-12
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-alcoholic fatty liver disease (NAFLD) is rising in prevalence, and will likely become the predominant cause of chronic liver disease in HIV-infected individuals.

Metabolic factors and obesity are important risk factors for NAFLD in HIV-infected individuals. There is currently no approved effective pharmacological treatment for fatty liver disease. Therefore, lifestyle modification directing at weight loss is currently the cornerstone of treatment for fatty liver disease in the general population. Hypocaloric diets can improve fatty liver in the general population, but the most effective specific dietary interventions are yet to be elucidated.

The study aims to 1. determine the efficacy of a lifestyle modification programme in inducing resolution of NAFLD in HIV-infected individuals 2. to determine the efficacy of a lifestyle modification programme in improving insulin resistance, pro-inflammatory markers, and liver fibrosis in HIV-infected individuals with fatty liver disease 3. to determine changes in intestinal microbiome secondary to the lifestyle modification programme, and the association with resolution of NAFLD in this group of patients.


Eligibility criteria: Inclusion Criteria:

* age 18 years or above
* positive HIV antibody, on anti-retroviral therapy
* HIV viral load ≤50 copies/mL for ≥6 months
* intrahepatic triglyceride content ≥5% on magnetic resonance spectroscopy

Exclusion Criteria:

* current AIDS-defining illness
* active malignancy, or history of malignancy within the last 5 years
* hepatitis B and/or hepatitis C co-infection, as determined by positive HBsAg and anti--HCV antibody
* alcohol consumption \>30g per week in men or 20g per week in women
* alanine aminotransferase (ALT) above 10 times the upper limit of normal
* liver decompensation (as evidenced by bilirubin above 50 µmol/l, platelet count below 100 × 109/l, prothrombin time above 1.3 times the upper limit of normal, albumin below 35 g/l, presence of ascites or varices).

Primary outcomes:
measure: Resolution of NAFLD
timeFrame: 12 months
Secondary outcomes:
measure: Partial resolution of NAFLD
timeFrame: 12 months
measure: Changes in adiposity
timeFrame: 12 months
measure: Change in liver fibrosis
timeFrame: 12 months
measure: Metabolic endpoints
timeFrame: 12 months
measure: Metabolic endpoints
timeFrame: 12 months
measure: Metabolic endpoints
timeFrame: 12 months
measure: Metabolic endpoints
timeFrame: 12 months
measure: Metabolic endpoints
timeFrame: 12 months
measure: Metabolic endpoints
timeFrame: 12 months
measure: Biomarkers of inflammation and monocyte activation
timeFrame: 12 months
measure: Biomarkers of inflammation and monocyte activation
timeFrame: 12 months
measure: Biomarkers of inflammation and monocyte activation
timeFrame: 12 months
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References: