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

29. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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).

Studietype

Observasjonsmessig

Registrering (Antatt)

411

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Tyrkia (Türkiye)
      • Adana, Tyrkia (Türkiye)
        • Rekruttering
        • Adana Acıbadem Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Behice Kurtaran, MD, Prof.
      • Adana, Tyrkia (Türkiye)
        • Rekruttering
        • Cukurova University, Faculty of Medicine
        • Ta kontakt med:
        • Hovedetterforsker:
          • Yesim Tasova, MD, Prof.
      • Ankara, Tyrkia (Türkiye)
        • Rekruttering
        • Hacettepe University, Faculty of Medicine
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ahmet Cagkan Inkaya, MD, Prof.
        • Underetterforsker:
          • Nursel Calik Basaran, MD, Prof.
        • Underetterforsker:
          • Meliha Cagla Sonmezer, MD, Assoc. Prof.
      • Antalya, Tyrkia (Türkiye)
        • Rekruttering
        • Akdeniz University, Faculty of Medicine
        • Ta kontakt med:
        • Hovedetterforsker:
          • Dilara Inan, MD, Prof.
      • Diyarbakır, Tyrkia (Türkiye), TR21280
        • Rekruttering
        • Dicle University, Faculty of Medicine
        • Ta kontakt med:
        • Hovedetterforsker:
          • Mustafa Kemal Celen, MD, Prof.
        • Underetterforsker:
          • Cigdem Mermutluoglu, MD, Assoc. Prof.
      • Gaziantep, Tyrkia (Türkiye)
        • Rekruttering
        • Gaziantep University, Faculty of Medicine
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ilkay Karaoglan, MD, Prof.
        • Underetterforsker:
          • Ayse Ozlem Mete, MD, Assoc. Prof.
      • Istanbul, Tyrkia (Türkiye)
        • Rekruttering
        • Health Sciences University Hamidiye Faculty of Medicine
        • Ta kontakt med:
        • Hovedetterforsker:
          • Funda Simsek, MD, Prof.
      • Izmir, Tyrkia (Türkiye)
        • Rekruttering
        • Ege University, Faculty of Medicine
        • Ta kontakt med:
          • Husnu Pullukcu, MD, Prof.
          • Telefonnummer: +905334231918
          • E-post: husnup@yahoo.com
        • Hovedetterforsker:
          • Husnu Pullukcu, MD, Prof.
      • Kocaeli, Tyrkia (Türkiye)
        • Rekruttering
        • Kocaeli University, Faculty of Medicine
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sila Akhan, MD, Prof.
      • Sanliurfa, Tyrkia (Türkiye)
        • Rekruttering
        • Harran University, Faculty of Medicine
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tuba Damar Cakirca, MD, Assoc. Prof.
    • Ankara
      • Ankara, Ankara, Tyrkia (Türkiye), 06850
        • Rekruttering
        • Guven Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Diagnostisk 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.
Diagnostisk 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.
Annen: 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.
Diagnostisk 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.
Diagnostisk 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Hepatic Steatosis (CAP)
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Yaşar Bayındır, MD

Samarbeidspartnere

Ilko Ilac San. ve Tic. A.S.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2024

Primær fullføring (Antatt)

1. mai 2027

Studiet fullført (Antatt)

31. mai 2029

Datoer for studieregistrering

Først innsendt

27. juli 2026

Først innsendt som oppfylte QC-kriteriene

29. juli 2026

Først lagt ut (Faktiske)

30. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CETA-2024-MASHIV-TR-001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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