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

29 de julho de 2026 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Observacional

Inscrição (Estimado)

411

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.
Teste de diagnostico: 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.
Teste de diagnostico: 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.
Outro: 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.
Teste de diagnostico: 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.
Teste de diagnostico: 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.
Outro: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Hepatic Steatosis (CAP)
Prazo: 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)
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Yaşar Bayındır, MD

Colaboradores

Ilko Ilac San. ve Tic. A.S.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de junho de 2024

Conclusão Primária (Estimado)

1 de maio de 2027

Conclusão do estudo (Estimado)

31 de maio de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

27 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de julho de 2026

Primeira postagem (Real)

30 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CETA-2024-MASHIV-TR-001

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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