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NCT03913351
Lifestyle Modification Programme for HIV-infected Individuals With Fatty Liver
NA trial testing Lifestyle modification in NAFLD in 96 participants. Status unknown.
30 December 2023
Quick facts
| Lead sponsor | Chinese University of Hong Kong |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 96 |
| Start date | 21 May 2019 |
| Primary completion | 30 December 2023 |
| Estimated completion | 30 December 2023 |
| Sites | 1 location across Hong Kong |
Drugs / interventions tested
- Lifestyle modification
Conditions studied
Sponsor
Chinese University of Hong Kong
Who can join
18 and older, any sex, with NAFLD or Hiv. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Lifestyle modification programme for people living with HIV with metabolic dysfunction-associated steatotic liver disease: a randomised controlled trial.
Li G, Wong VW, Chan RS, Sin DM, et al · · 2025 · cited 4× · PMID 40347962 · DOI 10.1016/s2352-3018(25)00032-3
Verify or expand the search:
- PubMed search for NCT03913351
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03913351 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chinese University of Hong Kong
- Last refreshed: 30 August 2023
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