Liver disease and outcomes in people living with HIV
Construction of Prediction Models for Metabolic - Associated Fatty Liver Disease and Liver Fibrosis in HIV - Infected Individuals
This project will test whether routine non-invasive tests (FibroScan, ultrasound, and body composition) can identify people with HIV who later develop significant liver disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 320 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Shanghai Public Health Clinical Center Government |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Trial ID | NCT06940375 on ClinicalTrials.gov |
What this trial studies
This observational cohort uses patients with HIV who had abdominal ultrasound and FibroScan between December 2019 and April 2020 and were followed at a single center through April 2025. Researchers will use liver stiffness measurements (LSM), controlled attenuation parameter (CAP), body composition data, and clinical scores such as APRI, FIB-4, and the FAST score to track liver disease progression. The study excludes people with other liver diseases, heavy alcohol use, and pregnant or lactating women to focus on metabolic-associated fatty liver disease in the context of HIV. The primary aim is to measure incidence of liver disease-related outcomes and examine how well non-invasive markers identify significant fibrosis and steatohepatitis in this population.
Who should consider this trial
Good fit: Adults aged 18–70 with HIV who had abdominal ultrasound and FibroScan between December 2019 and April 2020 and were followed at the Shanghai Public Health Clinical Center.
Not a fit: Patients with other liver diseases, heavy alcohol use, pregnant or breastfeeding women, or those lacking the required imaging or follow-up data are unlikely to benefit from the study's findings.
Why it matters
Potential benefit: If successful, this work could help clinicians detect significant liver fibrosis and metabolic steatohepatitis earlier in people with HIV using routine non-invasive tests.
How similar studies have performed: Non-invasive scores like FAST, APRI, and FIB-4 have shown usefulness for identifying fibrosis in general and metabolic-associated fatty liver populations, but validation specifically in people with HIV has been limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged between 18 and 70 years old 2. HIV positive individuls 3. Had abdominal ultrasound and Fibroscan done between December 2019 and April 2020, with available data of LSM and CAP, and had routine follow - up at our hospital's outpatient department from April 2020 to April 2025. Exclusion Criteria: 1. Men with excessive alcohol consumption (more than 210g/week) and women with excessive alcohol consumption (more than 140g/week). 2. Suffering from other liver diseases, such as viral hepatitis, drug-induced liver disease, autoimmune liver disease, decompensated liver cirrhosis, liver malignancy, or having had a liver transplantation. 3. Pregnant women and lactating women.
Where this trial is running
Shanghai, Shanghai Municipality and 1 other locations
- Shanghai Public Health Clinical Center — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
- Shanghai Public Health Clinical Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yinzhong Shen, PhD
- Email: shenyinzhong@shphc.org.cn
- Phone: +8618916113951
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.