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

2026年7月29日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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).

研究类型

观察性的

注册 (估计的)

411

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 土耳其（türkiye）
      • Adana、土耳其（türkiye）
        • 招聘中
        • Adana Acıbadem Hospital
        • 接触：
        • 首席研究员：
          • Behice Kurtaran, MD, Prof.
      • Adana、土耳其（türkiye）
        • 招聘中
        • Cukurova University, Faculty of Medicine
        • 接触：
        • 首席研究员：
          • Yesim Tasova, MD, Prof.
      • Ankara、土耳其（türkiye）
        • 招聘中
        • Hacettepe University, Faculty of Medicine
        • 接触：
        • 首席研究员：
          • Ahmet Cagkan Inkaya, MD, Prof.
        • 副研究员：
          • Nursel Calik Basaran, MD, Prof.
        • 副研究员：
          • Meliha Cagla Sonmezer, MD, Assoc. Prof.
      • Antalya、土耳其（türkiye）
        • 招聘中
        • Akdeniz University, Faculty of Medicine
        • 接触：
        • 首席研究员：
          • Dilara Inan, MD, Prof.
      • Diyarbakır、土耳其（türkiye）、TR21280
        • 招聘中
        • Dicle University, Faculty of Medicine
        • 接触：
        • 首席研究员：
          • Mustafa Kemal Celen, MD, Prof.
        • 副研究员：
          • Cigdem Mermutluoglu, MD, Assoc. Prof.
      • Gaziantep、土耳其（türkiye）
        • 招聘中
        • Gaziantep University, Faculty of Medicine
        • 接触：
        • 首席研究员：
          • Ilkay Karaoglan, MD, Prof.
        • 副研究员：
          • Ayse Ozlem Mete, MD, Assoc. Prof.
      • Istanbul、土耳其（türkiye）
        • 招聘中
        • Health Sciences University Hamidiye Faculty of Medicine
        • 接触：
        • 首席研究员：
          • Funda Simsek, MD, Prof.
      • Izmir、土耳其（türkiye）
        • 招聘中
        • Ege University, Faculty of Medicine
        • 接触：
          • Husnu Pullukcu, MD, Prof.
          • 电话号码：+905334231918
          • 邮箱：husnup@yahoo.com
        • 首席研究员：
          • Husnu Pullukcu, MD, Prof.
      • Kocaeli、土耳其（türkiye）
        • 招聘中
        • Kocaeli University, Faculty of Medicine
        • 接触：
        • 首席研究员：
          • Sila Akhan, MD, Prof.
      • Sanliurfa、土耳其（türkiye）
        • 招聘中
        • Harran University, Faculty of Medicine
        • 接触：
        • 首席研究员：
          • Tuba Damar Cakirca, MD, Assoc. Prof.
    • Ankara
      • Ankara、Ankara、土耳其（türkiye）、06850

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
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.
诊断测试：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.
诊断测试：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.
其他：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.
诊断测试：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.
诊断测试：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.
其他：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Hepatic Steatosis (CAP)
大体时间：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)
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Yaşar Bayındır, MD

合作者

Ilko Ilac San. ve Tic. A.S.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年6月1日

初级完成 (估计的)

2027年5月1日

研究完成 (估计的)

2029年5月31日

研究注册日期

首次提交

2026年7月27日

首先提交符合 QC 标准的

2026年7月29日

首次发布 (实际的)

2026年7月30日

研究记录更新

最后更新发布 (实际的)

2026年7月30日

上次提交的符合 QC 标准的更新

2026年7月29日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CETA-2024-MASHIV-TR-001

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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