Metabolic Liver Disease in Newly Diagnosed People Living With HIV (MASHIV-TR)

NCT07737340 | Recruiting DMC

• 1 other identifier: CETA-2024-MASHIV-TR-001
• Study Type: observational
• Target: 411
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

HIV Infections; Fatty Liver; Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) & Steatohepatitis (MASH)

Keywords

HIV; Newly Diagnosed HIV Infection; Antiretroviral Therapy (ART); Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD); Metabolic Dysfunction-Associated Steatohepatitis (MASH); Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

• Change in Hepatic Steatosis (CAP)

  The development and progression of hepatic steatosis will be quantitatively assessed using FibroScan to record the Controlled Attenuation Parameter (CAP, measured in dB/m). Changes in CAP values will be compared between newly diagnosed HIV patients and healthy controls.

  Baseline, 12, 24, 36, 48, and 60 months

• Change in Liver Fibrosis (LSM)

  The development and progression of liver fibrosis will be quantitatively assessed using FibroScan to record the Liver Stiffness Measurement (LSM, measured in kPa). Changes in LSM values will be compared between newly diagnosed HIV patients and healthy controls.

  Baseline, 12, 24, 36, 48, and 60 months

Study Arms (2)

Newly Diagnosed HIV Patients

250 individuals newly diagnosed with HIV who are initiating Antiretroviral Therapy (ART). This group will be prospectively monitored for the development of metabolic liver disease and MASLD risk factors over 60 months.

Diagnostic Test: FibroScan (Transient Elastography); Diagnostic Test: Hepatobiliary Ultrasonography (USG); Other: Clinical and Laboratory Monitoring

Healthy Controls

161 healthy individuals without an HIV diagnosis. This group will serve as the comparative control group and will undergo the same prospective metabolic and hepatic evaluations over 60 months.

Diagnostic Test: FibroScan (Transient Elastography); Diagnostic Test: Hepatobiliary Ultrasonography (USG); Other: Clinical and Laboratory Monitoring

Interventions

FibroScan (Transient Elastography) DIAGNOSTIC_TEST

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.

Healthy Controls; Newly Diagnosed HIV Patients

Hepatobiliary Ultrasonography (USG) DIAGNOSTIC_TEST

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.

Healthy Controls; Newly Diagnosed HIV Patients

Clinical and Laboratory Monitoring OTHER

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.

Healthy Controls; Newly Diagnosed HIV Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

he study population consists of 411 adult participants (≥ 18 years of age) who are citizens of the Republic of Türkiye, enrolled across 9 different clinical centers nationwide (Adana, Ankara, Antalya, Diyarbakır, Gaziantep, İstanbul, İzmir, Kocaeli, and Şanlıurfa). The population is divided into two distinct cohorts: a patient group comprising 250 newly diagnosed individuals living with HIV who are initiating Antiretroviral Therapy (ART), and a comparative control group comprising 161 healthy, HIV-negative individuals.

You may qualify if:

• Citizens of the Republic of Türkiye
• Adults (≥ 18 years of age)
• Confirmed Anti-HIV positive (Newly diagnosed)
• Patients who are initiating Antiretroviral Therapy (ART)
• Citizens of the Republic of Türkiye
• Adults (≥ 18 years of age)
• Confirmed Anti-HIV negative

Sponsors & Collaborators

• Yaşar Bayındır, MD: lead
• Ilko Ilac San. ve Tic. A.S.: collaborator

Study Sites (11)

Guven Hospital

Ankara, Ankara, 06850, 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, TR21280, Turkey (Türkiye)

RECRUITING

Gaziantep University, Faculty of Medicine

Gaziantep, Turkey (Türkiye)

RECRUITING

Health Sciences University Hamidiye Faculty of Medicine

Istanbul, Turkey (Türkiye)

RECRUITING

Ege University, Faculty of Medicine

Izmir, Turkey (Türkiye)

RECRUITING

Kocaeli University, Faculty of Medicine

Kocaeli, Turkey (Türkiye)

RECRUITING

Harran University, Faculty of Medicine

Sanliurfa, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

HIV Infections; Fatty Liver; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Liver Diseases; Digestive System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Yaşar Bayındır, MD, Prof.

CONTACT

+905323659909; yasar.bayindir@guven.com.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician, Prof. Dr., M.D.

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start: June 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 31, 2029
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (11)