Metabolic Liver Disease in People Newly Diagnosed with HIV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multi-center observational study enrolling 250 newly diagnosed people living with HIV and 161 HIV-negative controls in Turkey. Participants will undergo baseline liver assessments and annual follow-ups for up to 5 years, including physical exams, labs, and liver imaging. The goal is to identify risk factors linked to the development of MASLD and to compare trajectories between the HIV-positive and HIV-negative groups. Transient elastography and hepatobiliary ultrasound are used to monitor liver health, along with standard clinical and laboratory measurements. Data will help map metabolic and hepatic risk factors over time to inform prevention and management strategies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Guven Hospital
  Ankara, Ankara, Turkey (Türkiye) Recruiting
• Adana Acıbadem Hospital
  Adana, Turkey (Türkiye) Recruiting
• Cukurova University, Faculty of Medicine
  Adana, Turkey (Türkiye) Recruiting
• Hacettepe University, Faculty of Medicine
  Ankara, Turkey (Türkiye) Recruiting
• Akdeniz University, Faculty of Medicine
  Antalya, Turkey (Türkiye) Recruiting
• Dicle University, Faculty of Medicine
  Diyarbakır, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Yaşar Bayındır, MD, Prof.
• Email: yasar.bayindir@guven.com.tr
• Phone: +905323659909

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.