[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583750":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":29,"responsibleParty":49,"collaborators":51,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":17,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":32,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CAR-T","EXPERIMENTAL",null,[13],"Biological: HIV-CAR-T",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"BIOLOGICAL","HIV-CAR-T","Intravenous Infusion of CAR-T Cells",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Xiao Wang, D.Eng","CONTACT","+86 22 2746 8129","wangx21@mails.tsinghua.edu.cn",{"name":27,"role":23,"phone":11,"phoneExt":11,"email":28},"Xuanling Shi, MD","shixuanlingsk@mail.tsinghua.edu.cn",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Chinese Academy of Medical Sciences Hospital of Hematology (Chinese Academy of Medical Sciences Institute of Hematology), Tianjin, 300020","RECRUITING","Tianjin","Tianjin Municipality","300020","China","CN",{"type":39,"coordinates":40},"Point",[41,42],117.17667,39.14222,{"lat":42,"lon":41},[45],{"name":46,"role":23,"phone":47,"phoneExt":11,"email":48},"Ying Wang","86-22-23608095","wangying1@ihcams.ac.cn",{"type":50,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[52],{"name":53,"class":6},"Tsinghua University","100583750","phase-1-the-efficacy-and-safety-study-of-car-t-cells-for-functional-cure-in-hiv-1aids-patients-100583750",false,"NCT06880380","The Efficacy and Safety Study of CAR-T Cells for Functional Cure in HIV-1\u002FAIDS Patients","Inclusion Criteria:\n\n1. Age between 18 and 65 years;\n2. Confirmed diagnosis of HIV-1 infection, with regular antiviral therapy ≥24 months prior to enrollment and sustained HIV-RNA levels \\\u003C50 copies\u002FmL for the 12 months preceding enrollment;\n3. CD4+ T-cell count \\>350\u002Fμl within 30 days prior to enrollment;\n4. Female participants of childbearing potential (including those ≤50 years old who are amenorrheic) must have a negative urine pregnancy test; from the screening period until the end of the study, participants should have no plans for conception and must voluntarily adopt effective contraceptive measures;\n5. Willingness to provide true identity information and comply with follow-up requirements;\n6. Ability to fully understand the study objectives, procedures, and potential risks, voluntary signing of an informed consent form, and adherence to the study requirements.\n\nExclusion Criteria:\n\n1. Women who are pregnant, breastfeeding, or of childbearing potential unwilling\u002Funable to use effective contraception.\n2. Coinfection with other viruses or infections, including HIV-2, HAV, HBV, HCV, HDV, HEV, EBV, CMV, or syphilis.\n3. History of AIDS-related opportunistic infections or malignancies within the past year (e.g., candidiasis, coccidioidomycosis, cryptococcosis, cytomegalovirus disease, herpes simplex, lymphoma).\n4. Autoimmune diseases requiring systemic immunosuppressive\u002Fimmunomodulatory therapy within the past 2 years (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus).\n5. Severe non-AIDS-related comorbidities, including uncontrolled clinically significant diseases of the genitourinary, cardiovascular, respiratory, neurological, psychiatric, gastrointestinal, endocrine, immune systems, or malignancies.\n6. Central nervous system (CNS) disorders, such as epilepsy, cerebral ischemia\u002Fhemorrhage, dementia, cerebellar diseases, or autoimmune conditions involving the CNS.\n7. Suspected or confirmed history of alcohol abuse, drug addiction, illicit substance use, or psychiatric disorders.\n8. Abnormal laboratory results within 14 days prior to enrollment meeting any of the following:\n\n   Hemoglobin \\\u003C10 g\u002FdL (female) or \\\u003C11 g\u002FdL (male) Absolute neutrophil count \\\u003C1 ×10⁹\u002FL Platelet count \\\u003C100 ×10⁹\u002FL Serum creatinine \\>110 μmol\u002FL INR \\>1.5 or PTT \\>45 seconds ALT or AST \\>2.5 × upper limit of normal (ULN) Total bilirubin \\>1.5 × ULN\n9. Current participation in another clinical trial that may conflict with the current protocol or outcome assessments.\n10. Any other condition deemed inappropriate for participation by the investigator.","ALL","18 Years","65 Years",{"count":64,"type":65},3,"ESTIMATED","INTERVENTIONAL",[68],"PHASE1","Autologous CAR-T cell therapy in HIV-1\u002FAIDS patients",[71,72],"HIV Infected Individuals","HIV",[9,72,74],"Autologous","2026-03-03",{"date":77,"type":78},"2026-03-05","ACTUAL",{"date":80,"type":78},"2025-09-01",{"date":82,"type":65},"2026-07-01",{"name":5,"class":6},1]