Lifestyle Modification Programme for HIV-infected Individuals With Fatty Liver

The Chinese University of Hong Kong

Status: Enrolling

Conditions: NAFLD; Hiv

Treatments: Behavioral: Lifestyle modification

Study type: Interventional

Funder types: Other

Identifiers

NCT03913351

Study Protocol LSM V2

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Lifestyle modification program

Experimental group

Description:

The dietary intervention program will be scheduled for 12 months, and conducted by a dietitian.The program aims to increase energy expenditure and reduce caloric intake, with an emphasis on long-term lifestyle and behavioural change. An exercise instructor will provide advice on physical activity. A mobile tracking device to monitor calories expenditure will be provided to each participant during they study period to encourage physical activity.

Treatment:

Behavioral: Lifestyle modification

Control

No Intervention group

Description:

standard care of treatment, as in routine clinical practice