Clinical trial No longer in our active list Interventional Ages 18 and up

Lifestyle changes for HIV patients with fatty liver

Official title: Lifestyle Modification Programme for HIV-infected Individuals With Non-alcoholic Fatty Liver Disease: A Randomized Controlled Trial

Run by Chinese University of Hong Kong · NCT03913351 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study tests whether a lifestyle change program that includes diet and exercise can help people with HIV and fatty liver disease improve their liver health.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment96 (estimated)
SponsorChinese University of Hong Kong
Academic / other
Locations1 site (Shatin)
Trial IDNCT03913351 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are HIV-infected individuals aged 18 and above, on anti-retroviral therapy, with a specific level of liver fat as determined by imaging.

Probably not a fit

Patients with active malignancies, severe liver disease, or co-infections such as hepatitis B or C may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a lifestyle modification program aimed at reducing non-alcoholic fatty liver disease (NAFLD) in individuals infected with HIV. It focuses on weight loss through dietary changes and physical activity to improve liver health and metabolic factors. The program will assess its impact on liver fat content, insulin resistance, inflammation, and liver fibrosis in participants. The study aims to provide insights into non-pharmacological interventions for managing fatty liver disease in this population.

Why it matters

Potential benefit: If successful, this program could significantly improve liver health and overall metabolic function in HIV-infected individuals with fatty liver disease.

How similar studies have gone: While lifestyle modifications have been effective in the general population for managing fatty liver disease, this specific approach in HIV-infected individuals is novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion 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).

Where it's running

  • Prince of Wales Hospital
    Shatin, Hong Kong
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.