Clinical Research Directory
Browse clinical research sites, groups, and studies.
Metabolic Liver Disease in Newly Diagnosed People Living With HIV (MASHIV-TR)
Sponsor: Yaşar Bayındır, MD
Summary
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.
Official title: Metabolic Liver Disease in Newly Diagnosed People Living With HIV: MASHIV-TR Cohort (MASHIV-TR)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
411
Start Date
2024-06-01
Completion Date
2029-05-31
Last Updated
2026-07-30
Healthy Volunteers
Yes
Conditions
Interventions
FibroScan (Transient Elastography)
Non-invasive measurement of liver stiffness (LSM) and controlled attenuation parameter (CAP) to evaluate liver fibrosis and steatosis. Measurements are taken at baseline and annually up to 60 months.
Hepatobiliary Ultrasonography (USG)
Routine ultrasound imaging of the liver and biliary tract to evaluate signs of metabolic liver disease and fatty liver. Assessed at baseline and annually up to 60 months.
Clinical and Laboratory Monitoring
Annual monitoring including anthropometric measurements (BMI), lipid profile, fasting glucose, HOMA-IR score, renal and liver function tests, and calculation of the FIB-4 index. For the patient group, details of the initiated Antiretroviral Therapy (ART) will also be recorded.
Locations (11)
Guven Hospital
Ankara, Ankara, Turkey (Türkiye)
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)