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

29 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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).

Type d'étude

Observationnel

Inscription (Estimé)

411

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Turquie (Türkiye)
      • Adana, Turquie (Türkiye)
        • Recrutement
        • Adana Acıbadem Hospital
        • Contact:
        • Chercheur principal:
          • Behice Kurtaran, MD, Prof.
      • Adana, Turquie (Türkiye)
        • Recrutement
        • Cukurova University, Faculty of Medicine
        • Contact:
          • Yesim Tasova, MD, Prof.
          • Numéro de téléphone: +905353088511
          • E-mail: ytasova@gmail.com
        • Chercheur principal:
          • Yesim Tasova, MD, Prof.
      • Ankara, Turquie (Türkiye)
        • Recrutement
        • Hacettepe University, Faculty of Medicine
        • Contact:
        • Chercheur principal:
          • Ahmet Cagkan Inkaya, MD, Prof.
        • Sous-enquêteur:
          • Nursel Calik Basaran, MD, Prof.
        • Sous-enquêteur:
          • Meliha Cagla Sonmezer, MD, Assoc. Prof.
      • Antalya, Turquie (Türkiye)
        • Recrutement
        • Akdeniz University, Faculty of Medicine
        • Contact:
        • Chercheur principal:
          • Dilara Inan, MD, Prof.
      • Diyarbakır, Turquie (Türkiye), TR21280
        • Recrutement
        • Dicle University, Faculty of Medicine
        • Contact:
          • Mustafa Kemal Celen, MD, Prof.
          • Numéro de téléphone: +905336207022
          • E-mail: mkcelen@hotmail.com
        • Chercheur principal:
          • Mustafa Kemal Celen, MD, Prof.
        • Sous-enquêteur:
          • Cigdem Mermutluoglu, MD, Assoc. Prof.
      • Gaziantep, Turquie (Türkiye)
        • Recrutement
        • Gaziantep University, Faculty of Medicine
        • Contact:
        • Chercheur principal:
          • Ilkay Karaoglan, MD, Prof.
        • Sous-enquêteur:
          • Ayse Ozlem Mete, MD, Assoc. Prof.
      • Istanbul, Turquie (Türkiye)
        • Recrutement
        • Health Sciences University Hamidiye Faculty of Medicine
        • Contact:
        • Chercheur principal:
          • Funda Simsek, MD, Prof.
      • Izmir, Turquie (Türkiye)
        • Recrutement
        • Ege University, Faculty of Medicine
        • Contact:
          • Husnu Pullukcu, MD, Prof.
          • Numéro de téléphone: +905334231918
          • E-mail: husnup@yahoo.com
        • Chercheur principal:
          • Husnu Pullukcu, MD, Prof.
      • Kocaeli, Turquie (Türkiye)
        • Recrutement
        • Kocaeli University, Faculty of Medicine
        • Contact:
        • Chercheur principal:
          • Sila Akhan, MD, Prof.
      • Sanliurfa, Turquie (Türkiye)
        • Recrutement
        • Harran University, Faculty of Medicine
        • Contact:
        • Chercheur principal:
          • Tuba Damar Cakirca, MD, Assoc. Prof.
    • Ankara
      • Ankara, Ankara, Turquie (Türkiye), 06850
        • Recrutement
        • Guven Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Test diagnostique: 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.
Test diagnostique: 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.
Autre: 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.
Test diagnostique: 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.
Test diagnostique: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Hepatic Steatosis (CAP)
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Yaşar Bayındır, MD

Collaborateurs

Ilko Ilac San. ve Tic. A.S.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juin 2024

Achèvement primaire (Estimé)

1 mai 2027

Achèvement de l'étude (Estimé)

31 mai 2029

Dates d'inscription aux études

Première soumission

27 juillet 2026

Première soumission répondant aux critères de contrôle qualité

29 juillet 2026

Première publication (Réel)

30 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CETA-2024-MASHIV-TR-001

Plan pour les données individuelles des participants (IPD)

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Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

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Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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