Lipidomic and Multi-Omics Profiling of Fatty Liver Disease in People With and Without HIV (NCT07640880) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Lipidomic and Multi-Omics Profiling of Fatty Liver Disease in People With and Without HIV
China120 participantsStarted 2026-06-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* Chronic liver disease with decompensated cirrhosis, hepatic malignancy, or history of liver transplantation
* Pregnancy or lactation
* Active severe infectious disease (other than HIV for Group 1)
* Severe critical illness or major organ failure
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of differentially abundant plasma lipid species identified by targeted lipidomics (UPLC-MS/MS)
Timeframe: At enrollment (single time point, cross-sectional)