[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053530":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":52,"collaborators":55,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":82,"overallStatus":93,"whyStopped":25,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Beijing University of Chinese Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Qiling Yiqi Tablets plus ART","EXPERIMENTAL","Participants receive Qiling Yiqi Tablets orally in addition to their background ART regimen for 48 weeks.",[13],"Drug: Qiling Yiqi Tablets plus ART",{"label":15,"type":16,"description":17,"interventionNames":18},"ART alone","ACTIVE_COMPARATOR","Participants continue ART according to applicable domestic and international ART guidelines",[19],"Drug: Antiretroviral Therapy (ART)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Qiling Yiqi Tablets: Qiling Yiqi Tablets are a marketed Chinese patent medicine (NMPA approval No. Z20050483; Sichuan Enwei Pharmaceutical Co., Ltd.). The formula includes Astragalus, Codonopsis, Atractylodes macrocephala, Poria, and related components. Dose: 6 tablets orally three times daily after meals with warm water for 48 weeks.Participants receive Qiling Yiqi Tablets orally in addition to their background ART regimen for 48 weeks.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Antiretroviral Therapy (ART)","Background ART regimen according to applicable domestic and international ART guidelines.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Mei Han, phD","CONTACT","+86 13401131731","hanmeizoujin@163.com",[37],{"facility":38,"status":25,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Beijing University of Traditional Chinese Medicine","Beijing","Beijing Municipality","100029","China","CN",{"type":45,"coordinates":46},"Point",[47,48],116.39723,39.9075,{"lat":48,"lon":47},[51],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},{"type":53,"investigatorFullName":54,"investigatorTitle":5,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Mei Han",[56],{"name":57,"class":6},"Chengdu University of Traditional Chinese Medicine","100053530","qiling-yiqi-tablets-plus-antiretroviral-therapy-for-hiv-immune-non-responders-with-lung-spleen-qi-deficiency-100053530",false,"NCT07698574","Qiling Yiqi Tablets Plus Antiretroviral Therapy for HIV Immune Non-responders With Lung-Spleen Qi Deficiency","A Pragmatic Randomized Controlled Trial of Qiling Yiqi Tablets Combined With Antiretroviral Therapy for Immune Reconstitution Failure in People With HIV and Lung-Spleen Qi Deficiency Syndrome","QLYQ-INR-pRCT","Inclusion Criteria:Aged 18 to 60 years, male or female. CD4+ T lymphocyte count \\\u003C350 cells\u002FuL. Meets diagnostic criteria for HIV-1 infection according to the Chinese Guidelines for Diagnosis and Treatment of HIV\u002FAIDS (2024 edition).\n\nMeets diagnostic criteria for incomplete immune reconstitution: ART for more than 4 years; peripheral blood viral load below the lower limit of detection (\\\u003C50 copies\u002FmL) for more than 3 years; persistent CD4+ T-cell count \\\u003C350 cells\u002FuL; and exclusion of other causes of long-term low CD4+ T-cell count.\n\nMeets the Traditional Chinese Medicine diagnostic criteria for lung-spleen qi deficiency syndrome, supported by the designated four-diagnostic instrument (model SZY-ZM-1) where applicable.\n\nVoluntarily agrees to participate and signs informed consent. -\n\nExclusion Criteria:Uncontrolled acute or chronic physical or mental illness. Poor adherence to ART. WBC \\\u003C2 x 10\\^9\u002FL, neutrophils \\\u003C1.0 x 10\\^9\u002FL, hemoglobin \\\u003C90 g\u002FL, platelets \\\u003C75 x 10\\^9\u002FL, or abnormal hepatic\u002Frenal function. Hepatic abnormality is defined as AST, ALT, or total bilirubin \\>=2 times the upper limit of normal; renal abnormality is defined as creatinine clearance below the normal value.\n\nOther serious comorbid disease, such as tumor, cirrhosis, or cardiovascular\u002Fcerebrovascular disease.\n\nPregnancy, lactation, or recent plan for pregnancy\u002Fchildbearing. Use of immunosuppressants or immunomodulators within 6 months before screening. Any other condition judged by the investigator to make the participant unsuitable for the study.\n\n\\-","ALL","18 Years","60 Years",{"count":70,"type":71},240,"ESTIMATED","INTERVENTIONAL",[74],"NA","This pragmatic randomized controlled trial evaluates whether Qiling Yiqi Tablets combined with antiretroviral therapy (ART) improves immune reconstitution in people with HIV who meet criteria for immune reconstitution failure and lung-spleen qi deficiency syndrome. Eligible participants are adults aged 18 to 60 years with HIV-1 infection, long-term viral suppression on ART, and persistently low CD4+ T-cell counts. A total of 240 participants will be randomized 1:1 to receive Qiling Yiqi Tablets plus ART or ART alone. Treatment lasts 48 weeks, followed by 48 weeks of follow-up. The primary outcomes are absolute CD4+ T-cell count and immune reconstitution response rate. Secondary outcomes include immune homeostasis markers, T-cell activation and Treg proportion, thymic output and inflammation-related markers, HIV RNA viral load, quality of life, clinical symptom scores, all-cause mortality, and safety.",[77,78,79,80,81],"HIV-1 Infection","Acquired Immunodeficiency Syndrome","Immune Reconstitution Failure","Immunological Non-responder","Lung-Spleen Qi Deficiency Syndrome",[83,84,85,86,87,88,89,90,91,92],"HIV","AIDS","immune non-responder","incomplete immune reconstitution","ART","CD4+ T cell","Traditional Chinese Medicine","Qiling Yiqi Tablets","pragmatic randomized controlled trial","pRCT","NOT_YET_RECRUITING","2026-07-07",{"date":96,"type":97},"2026-07-13","ACTUAL",{"date":99,"type":71},"2026-08",{"date":101,"type":71},"2029-02",{"name":5,"class":6},1]