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

29 de julio de 2026 actualizado por: Yaşar Bayındır, MD

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

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Background and Rationale:

The prospective determination of risk factors associated with the development of metabolic liver disease is of critical clinical importance, particularly in newly diagnosed People Living with HIV (PLWH). This multi-center, prospective, observational cohort study aims to identify and monitor the risk factors contributing to the development of Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) in newly diagnosed PLWH, compared to an HIV-negative healthy control group.

Study Design and Population:

The study will be conducted across 9 centers in Turkey (Adana, Ankara, Antalya, Diyarbakır, Gaziantep, İstanbul, İzmir, Kocaeli, and Şanlıurfa). The targeted enrollment is a total of 411 participants, consisting of 250 newly diagnosed HIV-positive individuals and 161 HIV-negative healthy controls.

Methodology and Follow-up:

Participants in both the patient and control groups will undergo comprehensive clinical, laboratory, and radiological evaluations at the time of diagnosis (baseline) and subsequently every 12 months for a total follow-up period of 5 years (60 months). By longitudinally tracking metabolic, anthropometric, and hepatic parameters, the study will map the incidence of MASLD and stratify the metabolic risk factors over time.

Clinical Assessments (Conducted at Baseline, 12, 24, 36, 48, and 60 months):

To ensure standardization across all follow-up visits, the following parameters will be uniformly evaluated at every study time point:

Demographic and Clinical Characteristics: BMI (Height and Weight), comprehensive medical history, family history, presence of comorbidities, current medications, lifestyle habits, alcohol and substance use, and sleep patterns.

HIV-Specific Parameters: Details of the initiated Antiretroviral Therapy (ART) regimen.

Laboratory Parameters: Fasting glucose, HOMA-IR score, Lipid profile (Total Cholesterol, Triglycerides, LDL, HDL, LDL/HDL ratio, VLDL), Renal function tests (GFR, creatinine, urea, proteinuria), and systemic/hepatic markers (CRP, AFP, INR, FIB-4 index).

Radiological and Non-Invasive Hepatic Evaluations: Hepatobiliary ultrasonography (USG) and FibroScan measurements (recording both Controlled Attenuation Parameter (CAP) and Liver Stiffness Measurement (LSM) values).

Tipo de estudio

De observación

Inscripción (Estimado)

411

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Turquía (Türkiye)
      • Adana, Turquía (Türkiye)
        • Reclutamiento
        • Adana Acıbadem Hospital
        • Contacto:
        • Investigador principal:
          • Behice Kurtaran, MD, Prof.
      • Adana, Turquía (Türkiye)
        • Reclutamiento
        • Cukurova University, Faculty of Medicine
        • Contacto:
          • Yesim Tasova, MD, Prof.
          • Número de teléfono: +905353088511
          • Correo electrónico: ytasova@gmail.com
        • Investigador principal:
          • Yesim Tasova, MD, Prof.
      • Ankara, Turquía (Türkiye)
        • Reclutamiento
        • Hacettepe University, Faculty of Medicine
        • Contacto:
        • Investigador principal:
          • Ahmet Cagkan Inkaya, MD, Prof.
        • Sub-Investigador:
          • Nursel Calik Basaran, MD, Prof.
        • Sub-Investigador:
          • Meliha Cagla Sonmezer, MD, Assoc. Prof.
      • Antalya, Turquía (Türkiye)
        • Reclutamiento
        • Akdeniz University, Faculty of Medicine
        • Contacto:
          • Dilara Inan, MD, Prof.
          • Número de teléfono: +905323706725
          • Correo electrónico: inan@akdeniz.edu.tr
        • Investigador principal:
          • Dilara Inan, MD, Prof.
      • Diyarbakır, Turquía (Türkiye), TR21280
        • Reclutamiento
        • Dicle University, Faculty of Medicine
        • Contacto:
          • Mustafa Kemal Celen, MD, Prof.
          • Número de teléfono: +905336207022
          • Correo electrónico: mkcelen@hotmail.com
        • Investigador principal:
          • Mustafa Kemal Celen, MD, Prof.
        • Sub-Investigador:
          • Cigdem Mermutluoglu, MD, Assoc. Prof.
      • Gaziantep, Turquía (Türkiye)
        • Reclutamiento
        • Gaziantep University, Faculty of Medicine
        • Contacto:
          • İlkay Karaoglan, MD, Prof.
          • Número de teléfono: +905359266763
          • Correo electrónico: ilkayn.can@gmail.com
        • Investigador principal:
          • Ilkay Karaoglan, MD, Prof.
        • Sub-Investigador:
          • Ayse Ozlem Mete, MD, Assoc. Prof.
      • Istanbul, Turquía (Türkiye)
        • Reclutamiento
        • Health Sciences University Hamidiye Faculty of Medicine
        • Contacto:
        • Investigador principal:
          • Funda Simsek, MD, Prof.
      • Izmir, Turquía (Türkiye)
        • Reclutamiento
        • Ege University, Faculty of Medicine
        • Contacto:
          • Husnu Pullukcu, MD, Prof.
          • Número de teléfono: +905334231918
          • Correo electrónico: husnup@yahoo.com
        • Investigador principal:
          • Husnu Pullukcu, MD, Prof.
      • Kocaeli, Turquía (Türkiye)
        • Reclutamiento
        • Kocaeli University, Faculty of Medicine
        • Contacto:
        • Investigador principal:
          • Sila Akhan, MD, Prof.
      • Sanliurfa, Turquía (Türkiye)
        • Reclutamiento
        • Harran University, Faculty of Medicine
        • Contacto:
          • Tuba Damar Cakirca, MD, Assoc. Prof.
          • Número de teléfono: +905444495379
          • Correo electrónico: dr.tubadamar@gmail.com
        • Investigador principal:
          • Tuba Damar Cakirca, MD, Assoc. Prof.
    • Ankara
      • Ankara, Ankara, Turquía (Türkiye), 06850
        • Reclutamiento
        • Guven Hospital
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
Prueba de diagnóstico: 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.
Prueba de diagnóstico: 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.
Otro: 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.
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.
Prueba de diagnóstico: 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.
Prueba de diagnóstico: 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.
Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Hepatic Steatosis (CAP)
Periodo de tiempo: Baseline, 12, 24, 36, 48, and 60 months
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)
Periodo de tiempo: Baseline, 12, 24, 36, 48, and 60 months
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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Yaşar Bayındır, MD

Colaboradores

Ilko Ilac San. ve Tic. A.S.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de junio de 2024

Finalización primaria (Estimado)

1 de mayo de 2027

Finalización del estudio (Estimado)

31 de mayo de 2029

Fechas de registro del estudio

Enviado por primera vez

27 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

29 de julio de 2026

Publicado por primera vez (Actual)

30 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CETA-2024-MASHIV-TR-001

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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