[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649650":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":10,"centralContacts":34,"locations":40,"responsibleParty":202,"collaborators":206,"id":210,"slug":211,"hasResults":212,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":218,"sex":219,"minAge":220,"maxAge":10,"enrollmentInfo":221,"targetDuration":224,"studyType":225,"phases":10,"briefSummary":226,"conditions":227,"keywords":231,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":247},{"fullName":5,"class":6},"Guven Health Group","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Newly Diagnosed HIV Patients",null,"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.",[13,14,15],"Diagnostic Test: FibroScan (Transient Elastography)","Diagnostic Test: Hepatobiliary Ultrasonography (USG)","Other: Clinical and Laboratory Monitoring",{"label":17,"type":10,"description":18,"interventionNames":19},"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.",[13,14,15],[21,26,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"DIAGNOSTIC_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.",[17,9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"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.",[17,9],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"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.",[17,9],[35],{"name":36,"role":37,"phone":38,"phoneExt":10,"email":39},"Yaşar Bayındır, MD, Prof.","CONTACT","+905323659909","yasar.bayindir@guven.com.tr",[41,56,71,82,98,112,129,146,160,174,188],{"facility":42,"status":43,"city":44,"state":44,"zip":45,"country":46,"countryCode":10,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Guven Hospital","RECRUITING","Ankara","06850","Turkey (Türkiye)",{"type":48,"coordinates":49},"Point",[50,51],32.85427,39.91987,{"lat":51,"lon":50},[54],{"name":36,"role":37,"phone":55,"phoneExt":10,"email":39},"05323659909",{"facility":57,"status":43,"city":58,"state":10,"zip":10,"country":46,"countryCode":10,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Adana Acıbadem Hospital","Adana",{"type":48,"coordinates":60},[61,62],35.32531,36.98615,{"lat":62,"lon":61},[65,69],{"name":66,"role":37,"phone":67,"phoneExt":10,"email":68},"Behice Kurtaran, MD, Prof.","+905327393613","behicekurtaran@gmail.com",{"name":66,"role":70,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"facility":72,"status":43,"city":58,"state":10,"zip":10,"country":46,"countryCode":10,"cosmosGeoPoint":73,"geoPoint":75,"contacts":76},"Cukurova University, Faculty of Medicine",{"type":48,"coordinates":74},[61,62],{"lat":62,"lon":61},[77,81],{"name":78,"role":37,"phone":79,"phoneExt":10,"email":80},"Yesim Tasova, MD, Prof.","+905353088511","ytasova@gmail.com",{"name":78,"role":70,"phone":10,"phoneExt":10,"email":10},{"facility":83,"status":43,"city":44,"state":10,"zip":10,"country":46,"countryCode":10,"cosmosGeoPoint":84,"geoPoint":86,"contacts":87},"Hacettepe University, Faculty of Medicine",{"type":48,"coordinates":85},[50,51],{"lat":51,"lon":50},[88,92,93,96],{"name":89,"role":37,"phone":90,"phoneExt":10,"email":91},"Ahmet Cagkan Inkaya, MD, Prof.","+905326828702","inkaya@hacettepe.edu.tr",{"name":89,"role":70,"phone":10,"phoneExt":10,"email":10},{"name":94,"role":95,"phone":10,"phoneExt":10,"email":10},"Nursel Calik Basaran, MD, Prof.","SUB_INVESTIGATOR",{"name":97,"role":95,"phone":10,"phoneExt":10,"email":10},"Meliha Cagla Sonmezer, MD, Assoc. Prof.",{"facility":99,"status":43,"city":100,"state":10,"zip":10,"country":46,"countryCode":10,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Akdeniz University, Faculty of Medicine","Antalya",{"type":48,"coordinates":102},[103,104],30.69556,36.90812,{"lat":104,"lon":103},[107,111],{"name":108,"role":37,"phone":109,"phoneExt":10,"email":110},"Dilara Inan, MD, Prof.","+905323706725","inan@akdeniz.edu.tr",{"name":108,"role":70,"phone":10,"phoneExt":10,"email":10},{"facility":113,"status":43,"city":114,"state":10,"zip":115,"country":46,"countryCode":10,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Dicle University, Faculty of Medicine","Diyarbakır","TR21280",{"type":48,"coordinates":117},[118,119],40.21721,37.91363,{"lat":119,"lon":118},[122,126,127],{"name":123,"role":37,"phone":124,"phoneExt":10,"email":125},"Mustafa Kemal Celen, MD, Prof.","+905336207022","mkcelen@hotmail.com",{"name":123,"role":70,"phone":10,"phoneExt":10,"email":10},{"name":128,"role":95,"phone":10,"phoneExt":10,"email":10},"Cigdem Mermutluoglu, MD, Assoc. Prof.",{"facility":130,"status":43,"city":131,"state":10,"zip":10,"country":46,"countryCode":10,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Gaziantep University, Faculty of Medicine","Gaziantep",{"type":48,"coordinates":133},[134,135],37.3825,37.05944,{"lat":135,"lon":134},[138,142,144],{"name":139,"role":37,"phone":140,"phoneExt":10,"email":141},"İlkay Karaoglan, MD, Prof.","+905359266763","ilkayn.can@gmail.com",{"name":143,"role":70,"phone":10,"phoneExt":10,"email":10},"Ilkay Karaoglan, MD, Prof.",{"name":145,"role":95,"phone":10,"phoneExt":10,"email":10},"Ayse Ozlem Mete, MD, Assoc. Prof.",{"facility":147,"status":43,"city":148,"state":10,"zip":10,"country":46,"countryCode":10,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Health Sciences University Hamidiye Faculty of Medicine","Istanbul",{"type":48,"coordinates":150},[151,152],28.94966,41.01384,{"lat":152,"lon":151},[155,159],{"name":156,"role":37,"phone":157,"phoneExt":10,"email":158},"Funda Simsek, MD, Prof.","+905325620953","fundasimsek67@gmail.com",{"name":156,"role":70,"phone":10,"phoneExt":10,"email":10},{"facility":161,"status":43,"city":162,"state":10,"zip":10,"country":46,"countryCode":10,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Ege University, Faculty of Medicine","Izmir",{"type":48,"coordinates":164},[165,166],27.13838,38.41273,{"lat":166,"lon":165},[169,173],{"name":170,"role":37,"phone":171,"phoneExt":10,"email":172},"Husnu Pullukcu, MD, Prof.","+905334231918","husnup@yahoo.com",{"name":170,"role":70,"phone":10,"phoneExt":10,"email":10},{"facility":175,"status":43,"city":176,"state":10,"zip":10,"country":46,"countryCode":10,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Kocaeli University, Faculty of Medicine","Kocaeli",{"type":48,"coordinates":178},[179,180],27.51145,39.62497,{"lat":180,"lon":179},[183,187],{"name":184,"role":37,"phone":185,"phoneExt":10,"email":186},"Sila Akhan, MD, Prof.","+905322666535","sila.akhan@kocaeli.edu.tr",{"name":184,"role":70,"phone":10,"phoneExt":10,"email":10},{"facility":189,"status":43,"city":190,"state":10,"zip":10,"country":46,"countryCode":10,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"Harran University, Faculty of Medicine","Sanliurfa",{"type":48,"coordinates":192},[193,194],38.79392,37.16708,{"lat":194,"lon":193},[197,201],{"name":198,"role":37,"phone":199,"phoneExt":10,"email":200},"Tuba Damar Cakirca, MD, Assoc. Prof.","+905444495379","dr.tubadamar@gmail.com",{"name":198,"role":70,"phone":10,"phoneExt":10,"email":10},{"type":203,"investigatorFullName":204,"investigatorTitle":205,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Yaşar Bayındır, MD","Chief Physician, Prof. Dr., M.D.",[207],{"name":208,"class":209},"Ilko Ilac San. ve Tic. A.S.","INDUSTRY","100649650","metabolic-liver-disease-in-newly-diagnosed-people-living-with-hiv-mashiv-tr-100649650",false,"NCT07737340","Metabolic Liver Disease in Newly Diagnosed People Living With HIV (MASHIV-TR)","Metabolic Liver Disease in Newly Diagnosed People Living With HIV: MASHIV-TR Cohort (MASHIV-TR)","MASHIV-TR","Inclusion Criteria (For the Patient Group \u002F Newly Diagnosed HIV+):\n\n* Citizens of the Republic of Türkiye\n* Adults (≥ 18 years of age)\n* Confirmed Anti-HIV positive (Newly diagnosed)\n* Patients who are initiating Antiretroviral Therapy (ART)\n\nInclusion Criteria (For the Healthy Control Group \u002F HIV-):\n\n* Citizens of the Republic of Türkiye\n* Adults (≥ 18 years of age)\n* Confirmed Anti-HIV negative\n\nExclusion Criteria:\n\n* There are no specified exclusion criteria for this study.",true,"ALL","18 Years",{"count":222,"type":223},411,"ESTIMATED","60 Months","OBSERVATIONAL","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.\n\nParticipants 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).\n\nDuring 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.",[228,229,230],"HIV Infections","Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) & Steatohepatitis (MASH)","Fatty Liver",[232,233,234,235,236,237],"HIV","Newly Diagnosed HIV Infection","Antiretroviral Therapy (ART)","Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD)","Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Metabolic Syndrome","2026-07-29",{"date":240,"type":241},"2026-07-30","ACTUAL",{"date":243,"type":241},"2024-06-01",{"date":245,"type":223},"2029-05-31",{"name":204,"class":6},11]