Lifestyle changes for HIV patients with fatty liver
Lifestyle Modification Programme for HIV-infected Individuals With Non-alcoholic Fatty Liver Disease: A Randomized Controlled Trial
NA · Chinese University of Hong Kong · NCT03913351
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 1 site (Shatin) |
| Trial ID | NCT03913351 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shatin
- Prince of Wales Hospital — Shatin, Hong Kong (RECRUITING)
Study contacts
- Study coordinator: Vivian Wong
- Email: vivianwong@cuhk.edu.hk
- Phone: +85259621224
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.