NCT07640880Not yet recruiting
Lipidomic and Multi-Omics Profiling of Fatty Liver Disease in People With and Without HIV
Multi-Omics Characterization of Lipid Metabolic Reprogramming in People With HIV Versus HIV-Negative Metabolic Dysfunction-Associated Steatotic Liver Disease
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
Metabolic dysfunction-associated steatotic liver disease (MASLD), commonly known as fatty liver disease, is increasingly prevalent worldwide. People living with HIV (PWH) face a higher risk of developing MASLD due to chronic immune activation and long-term antiretroviral therapy, yet whether the underlying biological changes differ from those in HIV-negative individuals with MASLD remains unknown. This prospective observational study will enroll three groups: PWH with MASLD, HIV-negative individuals with MASLD, and healthy controls without liver disease. A single fasting blood sample will be collected from each participant. Using targeted lipidomics, proteomics, and transcriptomics platforms, researchers will compare plasma molecular profiles across the three groups to identify MASLD-specific lipid signatures, characterize metabolic pathway dysregulation, and discover potential blood-based biomarkers for non-invasive diagnosis of MASLD. Findings from this study may help explain how HIV infection alters lipid metabolism in the context of MASLD and support the development of HIV-specific diagnostic tools for fatty liver disease.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 31 May 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Yinzhong Shen
- Diseases
- HIV, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07640880
What you commit to
- Study type: Observational
- Planned participants: 120
- From 1 Jun 2026 to the primary completion date, 1 Sept 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
- Chronic liver disease with decompensated cirrhosis, hepatic malignancy, or history of liver transplantation
- Active severe infectious disease (other than HIV for Group 1)
- Severe critical illness or major organ failure
Other
- Pregnancy or lactation
Who the study is looking for
- Age 18-80 years
- Able to provide written informed consent and cooperate with blood sample collection and clinical data recording
- For Group 1 (Treatment-naive people with HIV and MASLD):
- Confirmed HIV infection with no prior antiretroviral therapy (treatment-naive)
- Diagnosis of MASLD per the 2024 Chinese Guidelines: hepatic steatosis confirmed by imaging or histology (≥5% macrovesicular steatosis), exclusion of excessive alcohol consumption (\>210 g/week for men, \>140 g/week for women), and at least one metabolic cardiovascular risk factor
- For Group 2 (HIV-negative individuals with MASLD):
- HIV-negative
- Diagnosis of MASLD as defined above
- For Group 3 (Healthy Controls):
- HIV-negative
- Normal liver morphology on abdominal ultrasonography within the past year, with no evidence of hepatic steatosis
- Matched to MASLD groups by age (within 5 years), sex, and BMI (within 3 kg/m²)
Age in the registry: 18 years to 80 years · Sex: All · Accepts 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.