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

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Diagnostic test, Other
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Citizens of the Republic of Türkiye

• Adults (≥ 18 years of age)

• Confirmed Anti-HIV positive (Newly diagnosed)

• Patients who are initiating Antiretroviral Therapy (ART)

• Citizens of the Republic of Türkiye

• Adults (≥ 18 years of age)

• Confirmed Anti-HIV negative

Locations
Other Locations
Turkey
Adana Acıbadem Hospital
RECRUITING
Adana
Cukurova University, Faculty of Medicine
RECRUITING
Adana
Guven Hospital
RECRUITING
Ankara
Hacettepe University, Faculty of Medicine
RECRUITING
Ankara
Akdeniz University, Faculty of Medicine
RECRUITING
Antalya
Dicle University, Faculty of Medicine
RECRUITING
Diyarbakır
Gaziantep University, Faculty of Medicine
RECRUITING
Gaziantep
Health Sciences University Hamidiye Faculty of Medicine
RECRUITING
Istanbul
Ege University, Faculty of Medicine
RECRUITING
Izmir
Kocaeli University, Faculty of Medicine
RECRUITING
Kocaeli
Harran University, Faculty of Medicine
RECRUITING
Sanliurfa
Contact Information
Primary
Yaşar Bayındır, MD, Prof.
yasar.bayindir@guven.com.tr
+905323659909
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2029-05-31
Participants
Target number of participants: 411
Treatments
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.
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.
Sponsors
Collaborators: Ilko Ilac San. ve Tic. A.S.
Leads: Yaşar Bayındır, MD

This content was sourced from clinicaltrials.gov