MedTrace Logo

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

NCT07737340 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 411

Last updated 2026-07-30

No results posted yet for this study

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
  • Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) & Steatohepatitis (MASH)
  • Fatty Liver

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

OTHER

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.

Sponsors & Collaborators

  • Ilko Ilac San. ve Tic. A.S.

    collaborator INDUSTRY

  • Yaşar Bayındır, MD

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2027-05-31
Completion
2029-05-31

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07737340 on ClinicalTrials.gov