This study aims to identify the risk factors that lead to the development of metabolic liver disease in people who have been newly diagnosed with HIV. The research will take place across 9 centers in Türkiye and plans to include 250 newly diagnosed individuals with HIV, alongside 161 healthy individuals without HIV as a control group.
Participants will have their liver health checked when they first join the study (baseline) and then once a year for up to 5 years (at 12, 24, 36, 48, and 60 months). The main goal of these visits is to monitor their metabolic health and understand who is at risk of developing a fatty liver condition known as MASLD (Metabolic dysfunction-Associated Steatotic Liver Disease).
During each visit, the research team will collect information about the participants' general health, including their height, weight, medical and family history, lifestyle habits, and sleep patterns. They will also record any medications being taken, including HIV treatments. To thoroughly check liver health, researchers will use routine blood tests (measuring things like cholesterol, blood sugar, and kidney function) and painless, non-invasive imaging tests, such as ultrasounds and FibroScans, to measure liver fat and stiffness.
Who can participate
Age range
18 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 (For the Patient Group / Newly Diagnosed HIV+):
* Citizens of the Republic of Türkiye
* Adults (≥ 18 years of age)
* Confirmed Anti-HIV positive (Newly diagnosed)
* Patients who are initiating Antiretroviral Therapy (ART)
Inclusion Criteria (For the Healthy Control Group / HIV-):
* Citizens of the Republic of Türkiye
* Adults (≥ 18 years of age)
* Confirmed Anti-HIV negative
Exclusion Criteria:
* There are no specified exclusion criteria for this study.
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.
1This trial is specifically for people newly diagnosed with HIV — does my diagnosis timeline actually make me a potential candidate worth discussing with you, or has too much time passed since my diagnosis?
2The trial is measuring changes in liver fat (called hepatic steatosis) and liver scarring (called fibrosis) — do I currently have any signs of fatty liver or liver disease that would make tracking these things especially relevant to my situation?
3Since this study is listed as Phase NA, which often means it's observational or focused on understanding the condition rather than testing a treatment, can you explain what would actually happen to me if I participated — would I receive any intervention, or would I mainly be monitored and tested?
4Given that metabolic liver disease can be a serious complication for people living with HIV, are there standard-of-care steps I should be taking right now to protect my liver, regardless of whether I join this trial?
5How would participating in this trial fit alongside starting or adjusting my HIV treatment — could the two processes conflict with each other, or is this a good time to do both at once?
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
Change in Hepatic Steatosis (CAP)
Timeframe: Baseline, 12, 24, 36, 48, and 60 months
2
Change in Liver Fibrosis (LSM)
Timeframe: Baseline, 12, 24, 36, 48, and 60 months