NCT06940375Completed
Incidence of Liver Disease-Related Outcomes in People With HIV
Construction of Prediction Models for Metabolic - Associated Fatty Liver Disease and Liver Fibrosis in HIV - Infected Individuals
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
Antiretroviral therapy can effectively control the replication of HIV, prolong the lifespan of patients infected with HIV, and improve their quality of life.At the same time, non-AIDS-related diseases such as diabetes and chronic liver diseases are increasing day by day.Metabolic associated fatty liver disease (MAFLD) is a chronic progressive liver disease caused by overnutrition and insulin resistance in genetically susceptible individuals. It was formerly known as non-alcoholic fatty liver disease (NAFLD).With the continuous improvement of living standards and the constant change of lifestyles, the incidence of metabolic associated fatty liver disease is gradually increasing. Metabolic associated steatohepatitis (MASH) may further develop into liver cirrhosis, liver failure and hepatocellular carcinoma, and is the third most common cause of liver transplantation. In HIV patients, early identification of significant liver fibrosis and MASH with fibrosis is of vital importance.However, due to the fact that the pathogenesis of liver fibrosis in HIV patients is more complex than that in the general population, it involves multiple factors such as the virus, reverse transcriptase drugs, chronic inflammation, and immune disorders.However, the current clinical research on metabolic-related fatty liver fibrosis in people with HIV is still rather limited.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 315 (actual)
- First submitted
- 21 Mar 2025
- Start date
- Jul 2025
- Primary completion date
- Feb 2026
- Lead sponsor
- Shanghai Public Health Clinical Center
- Diseases
- HIV, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06940375
What you commit to
- Study type: Observational
- Participants enrolled: 315
- From Jul 2025 to the primary completion date, Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Men with excessive alcohol consumption (more than 210g/week) and women with excessive alcohol consumption (more than 140g/week).
- Pregnant women and lactating women.
Who the study is looking for
- Aged between 18 and 70 years old
- HIV positive individuls
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Public Health Clinical Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.