[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618836":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":44,"locations":55,"responsibleParty":76,"collaborators":49,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":49,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":49,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":58,"whyStopped":49,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Cairo University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group","PLACEBO_COMPARATOR","Patients in the control group will receive an identical placebo and Standard Antiretroviral Therapy (ART)",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"EMPA Group + SOC","EXPERIMENTAL","Patients in the intervention arm will receive Empagliflozin 10 mg once daily for 6 months in addition to the standard DTG-based antiretroviral therapy.",[19],"Drug: Empagliflozin (oral)",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Empagliflozin (oral)","Empagliflozin is an oral medication used primarily to treat type 2 diabetes. It belongs to a class of drugs called SGLT2 inhibitors (sodium-glucose co-transporter 2 inhibitors). Empagliflozin blocks SGLT2 proteins in the kidneys.\n\nThis prevents glucose reabsorption, causing excess sugar to be excreted in urine.\n\nIt helps lower blood sugar levels and can also reduce body weight and blood pressure.",[15],[27],"Mellitofix 10 mg",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","TDF\u002FFTC+DLG",[9],[33,34],"Group A","Inactive Substance",[36,39,42],{"name":37,"affiliation":5,"role":38},"Maggie Abbassi, Prof.","STUDY_DIRECTOR",{"name":40,"affiliation":5,"role":41},"Abedalrahman Dosoky","PRINCIPAL_INVESTIGATOR",{"name":43,"affiliation":5,"role":38},"Ahmed Kamel",[45,51],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"Abdelrahman Dosoky, Bachelor's degree","CONTACT","+201148534951",null,"abdelrahman.ibrahim@pharma.cu.edu.eg",{"name":52,"role":47,"phone":53,"phoneExt":49,"email":54},"Ahmed Kamel, PhD","+20 100 676 6275","ahmedm.kamel@pharma.cu.edu.eg",[56],{"facility":57,"status":58,"city":59,"state":49,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Faculty of Pharmacy, Cairo University | Kasr El-Aini, Cairo","RECRUITING","Cairo","11562","Egypt","EG",{"type":64,"coordinates":65},"Point",[66,67],31.24967,30.06263,{"lat":67,"lon":66},[70,72,74],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":71},"abdalrahman.mahmoud@pharma.cu.edu.eg",{"name":73,"role":47,"phone":49,"phoneExt":49,"email":71},"Dosoky",{"name":75,"role":41,"phone":49,"phoneExt":49,"email":49},"Abdelrahman Dosoky, Bachelor's deg",{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":49,"oldOrganization":49},"SPONSOR_INVESTIGATOR","Abdelrahman Mahmoud","Teaching and Research Assistant","100618836","phase-2-effect-of-empagliflozin-on-metabolic-outcomes-in-adults-living-with-hiv-receiving-dolutegravir-based-therapy-100618836",false,"NCT07336797","Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy","Role of Empagliflozin in Metabolic Changes Associated With Antiretroviral Therapy in Human Immunodeficiency Virus","Inclusion Criteria:\n\n* Age \\>18 years up to 65 years old.\n* Body Mass Index (BMI) \\> 30 kg\u002Fm\\^2.\n* Currently receiving an integrase strand transfer inhibitor (INSTI)-based regimen (dolutegravir-based ART).\n* Sustained virologic suppression, defined as HIV-1 RNA \\\u003C 200 copies\u002FmL for at least 6 months.\n* Current CD4 count \\> 250 cells\u002FmL.\n* Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of Diabetes Mellitus, defined as a fasting blood glucose level \\> 126 mg\u002FdL or glycated hemoglobin (HbA1c) \\> 6.5% (or per ADA definition).\n* Renal impairment (e.g., eGFR \\\u003C 60 ml\u002Fmin\u002F1.73m\\^2).\n* Active viral hepatitis B or C.\n* Hypersensitivity to empagliflozin or any of its excipients.\n* Pregnancy or breastfeeding.\n* Current use of other SGLT-2 inhibitors.\n* Drugs that may interact with empagliflozin (e.g., rifampin or phenytoin) or dolutegravir (e.g., antacids, carbamazepine, or phenytoin).\n* Current or recent use of medications known to be associated with significant weight gain (e.g., systemic corticosteroids, antipsychotics, mood stabilizers, or other agents with established weight-promoting effects).\n* Known thyroid disease, defined as TSH \\> 6.0 mIU\u002FL or \\\u003C 0.35 mIU\u002FL","ALL","18 Years","65 Years",{"count":91,"type":92},66,"ESTIMATED","INTERVENTIONAL",[95],"PHASE2","We investigate the role of empagliflozin in the treatment of obesity in PLWH.",[98,99,100],"Metabolic Syndrome","Obesity & Overweight","HIV (Human Immunodeficiency Virus)",[102,103,104,105,106,98,107],"Obesity","Empagliflozin","PLWH","HIV","SGLT-2 inhibitor","Weight","2026-01-02",{"date":110,"type":111},"2026-01-13","ACTUAL",{"date":113,"type":111},"2025-09-01",{"date":115,"type":92},"2027-12-30",{"name":78,"class":6},1]