Lifestyle Modification Programme for HIV-infected Individuals With Fatty Liver

NCT03913351 | Unknown

• 1 other identifier: Study Protocol LSM V2
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

NAFLD; Hiv

Outcome Measures

Primary Outcomes (1)

• Resolution of NAFLD

  The primary endpoint is the proportion of patients with resolution of NAFLD as determined by proton-magnetic resonance spectroscopy at month 12.

  12 months

Secondary Outcomes (12)

• Partial resolution of NAFLD

  12 months

• Changes in adiposity

  12 months

• Change in liver fibrosis

  12 months

• Metabolic endpoints

  12 months

• Metabolic endpoints

  12 months

Study Arms (2)

Lifestyle modification program

EXPERIMENTAL

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.

Behavioral: Lifestyle modification

Control

NO INTERVENTION

standard care of treatment, as in routine clinical practice

Interventions

Lifestyle modification BEHAVIORAL

The program consists of education on glycemic index, balanced diet, interpretation of food labels, food exchanges, healthy eating out techniques and healthy cooking methods.

Lifestyle modification program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

Related Publications (1)

• Li G, Wong VW, Chan RS, Sin DM, Chu W, Wong V, Cheung C, Lam S, Lin H, Yeung S, Li TC, Ho TH, Wong GL, Yip TC, Lui GC. Lifestyle modification programme for people living with HIV with metabolic dysfunction-associated steatotic liver disease: a randomised controlled trial. Lancet HIV. 2025 Jun;12(6):e416-e427. doi: 10.1016/S2352-3018(25)00032-3. Epub 2025 May 8.

  PMID: 40347962 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Vivian Wong

CONTACT

+85259621224; vivianwong@cuhk.edu.hk

Grace Lui

CONTACT

+85235051464; gracelui@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 12, 2019
• Study Start: May 21, 2019
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

HK (1)