Metabolic Liver Disease in Newly Diagnosed People Living With HIV (MASHIV-TR)
Recruiting · NCT07737340 · Observational (researchers observe without assigning treatment) · Lead sponsor: Yaşar Bayındır, MD
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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 is running
11 locations listed.
- Adana Acıbadem Hospital - Adana, Turkey (Türkiye)
- Cukurova University, Faculty of Medicine - Adana, Turkey (Türkiye)
- Hacettepe University, Faculty of Medicine - Ankara, Turkey (Türkiye)
- Akdeniz University, Faculty of Medicine - Antalya, Turkey (Türkiye)
- Dicle University, Faculty of Medicine - Diyarbakır, Turkey (Türkiye)
- Gaziantep University, Faculty of Medicine - Gaziantep, Turkey (Türkiye)
- Health Sciences University Hamidiye Faculty of Medicine - Istanbul, Turkey (Türkiye)
- Ege University, Faculty of Medicine - Izmir, Turkey (Türkiye)
- Kocaeli University, Faculty of Medicine - Kocaeli, Turkey (Türkiye)
- Harran University, Faculty of Medicine - Sanliurfa, Turkey (Türkiye)
- Guven Hospital - Ankara, Ankara, Turkey (Türkiye)