HIV InfectionsMASHIV-TRNCT07737340
Metabolic Liver Disease in Newly Diagnosed People Living With HIV (MASHIV-TR)
An observational study of HIV Infections and Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) & Steatohepatitis (MASH), run by Yaşar Bayındır, MD at 11 sites in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) & Steatohepatitis (MASH), Fatty Liver
- What is being tested?
- FibroScan (Transient Elastography), Hepatobiliary Ultrasonography (USG) and Clinical and Laboratory Monitoring
- How many people
- 411 participants
- Where
- 11 sitesTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 31 May 2029
- How long will I take part?
- 60 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Citizens of the Republic of Türkiye
- Adults (≥ 18 years of age)
- Confirmed Anti-HIV negative
Who cannot join
- There are no specified exclusion criteria for this study.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Turkey (Türkiye)11 sites, 11 recruiting
- Recruiting
Adana Acıbadem Hospital
Adana
Behice Kurtaran, MD, Prof., +905327393613, behicekurtaran@gmail.com
Behice Kurtaran, MD, Prof.
- Recruiting
Cukurova University, Faculty of Medicine
Adana
Yesim Tasova, MD, Prof., +905353088511, ytasova@gmail.com
Yesim Tasova, MD, Prof.
- Recruiting
Guven Hospital
Ankara, Ankara, 06850
Yaşar Bayındır, MD, Prof., 05323659909, yasar.bayindir@guven.com.tr
- Recruiting
Hacettepe University, Faculty of Medicine
Ankara
Ahmet Cagkan Inkaya, MD, Prof., +905326828702, inkaya@hacettepe.edu.tr
Ahmet Cagkan Inkaya, MD, Prof.
- Recruiting
Akdeniz University, Faculty of Medicine
Antalya
Dilara Inan, MD, Prof., +905323706725, inan@akdeniz.edu.tr
Dilara Inan, MD, Prof.
- Recruiting
Dicle University, Faculty of Medicine
Diyarbakır, TR21280
Mustafa Kemal Celen, MD, Prof., +905336207022, mkcelen@hotmail.com
Mustafa Kemal Celen, MD, Prof.
- Recruiting
Gaziantep University, Faculty of Medicine
Gaziantep
İlkay Karaoglan, MD, Prof., +905359266763, ilkayn.can@gmail.com
Ilkay Karaoglan, MD, Prof.
- Recruiting
Health Sciences University Hamidiye Faculty of Medicine
Istanbul
Funda Simsek, MD, Prof., +905325620953, fundasimsek67@gmail.com
Funda Simsek, MD, Prof.
- Recruiting
Ege University, Faculty of Medicine
Izmir
Husnu Pullukcu, MD, Prof., +905334231918, husnup@yahoo.com
Husnu Pullukcu, MD, Prof.
- Recruiting
Kocaeli University, Faculty of Medicine
Kocaeli
Sila Akhan, MD, Prof., +905322666535, sila.akhan@kocaeli.edu.tr
Sila Akhan, MD, Prof.
- Recruiting
Harran University, Faculty of Medicine
Sanliurfa
Tuba Damar Cakirca, MD, Assoc. Prof., +905444495379, dr.tubadamar@gmail.com
Tuba Damar Cakirca, MD, Assoc. Prof.
About this study
Official title: 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.
Read the detailed description
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).
- Conditions
- HIV Infections, Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) & Steatohepatitis (MASH), Fatty Liver
- Being tested
- FibroScan (Transient Elastography), Hepatobiliary Ultrasonography (USG), Clinical and Laboratory Monitoring
- Keywords
- HIV, Newly Diagnosed HIV Infection, Antiretroviral Therapy (ART), Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD), Metabolic Dysfunction-Associated Steatohepatitis (MASH), Metabolic Syndrome
- Medical subject headings
- HIV Infections, Fatty Liver, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroScan (Transient Elastography)Diagnostic test
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.
Hepatobiliary Ultrasonography (USG)Diagnostic test
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.
Clinical and Laboratory MonitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: FibroScan (Transient Elastography); Diagnostic Test: Hepatobiliary Ultrasonography (USG); Other: Clinical and Laboratory Monitoring | |
| 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. Receives: Diagnostic Test: FibroScan (Transient Elastography); Diagnostic Test: Hepatobiliary Ultrasonography (USG); Other: Clinical and Laboratory Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hepatic Steatosis (CAP)
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.
Measured: Baseline, 12, 24, 36, 48, and 60 months
Change in Liver Fibrosis (LSM)
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.
Measured: Baseline, 12, 24, 36, 48, and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Jun 2024
- Primary completionMay 2027 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 411 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Yaşar Bayındır, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Ilko Ilac San. ve Tic. A.S.
- Responsible party
- Sponsor-investigator, Yaşar Bayındır, MD, Guven Health Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737340
- Sponsor's protocol ID
- CETA-2024-MASHIV-TR-001
- Acronym
- MASHIV-TR
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Liver Disease in Newly Diagnosed People Living With HIV: MASHIV-TR Cohort (MASHIV-TR)
- ClinicalTrials.gov ID
- NCT07737340
- Acronym / sponsor ID
- MASHIV-TR / CETA-2024-MASHIV-TR-001
- Conditions
- HIV Infections, Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) & Steatohepatitis (MASH), Fatty Liver
- Keywords
- HIV, Newly Diagnosed HIV Infection, Antiretroviral Therapy (ART), Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD), Metabolic Dysfunction-Associated Steatohepatitis (MASH), Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 411 participants (estimated)
- Lead sponsor
- Yaşar Bayındır, MDUniversity, hospital or other
- Collaborators
- Ilko Ilac San. ve Tic. A.S.
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Newly Diagnosed HIV Patients | – | Diagnostic Test: FibroScan (Transient Elastography), Diagnostic Test: Hepatobiliary Ultrasonography (USG), Other: Clinical and Laboratory Monitoring250 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. |
| Healthy Controls | – | Diagnostic Test: FibroScan (Transient Elastography), Diagnostic Test: Hepatobiliary Ultrasonography (USG), Other: Clinical and Laboratory Monitoring161 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Citizens of the Republic of Türkiye
- Adults (≥ 18 years of age)
- Confirmed Anti-HIV negative
Key exclusion criteria (1 listed)
- There are no specified exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Healthy Controls, Newly Diagnosed HIV Patients |
| 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. | Diagnostic test | Healthy Controls, Newly Diagnosed HIV Patients |
| Clinical and Laboratory MonitoringAnnual 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. | Other | Healthy Controls, Newly Diagnosed HIV Patients |
Primary outcome
Change in Hepatic Steatosis (CAP)
Time frame: 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.
Change in Liver Fibrosis (LSM)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) & Steatohepatitis (MASH), run by Yaşar Bayındır, MD at 11 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaşar Bayındır, MD, Prof. (+905323659909, yasar.bayindir@guven.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hepatic Steatosis (CAP) (time frame: Baseline, 12, 24, 36, 48, and 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.