[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Public Health Clinical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":260},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,43,70,94,120,143,162,190,211,239],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100643820","phase-4-comparative-trial-between-ainuovirineanvlamivudine3tctenofovirtdf-and-efavirenzefvlamivudinetenofovir-regimens-100643820",false,"NCT07631897","Comparative Trial Between Ainuovirine(ANV)\u002FLamivudine(3TC)\u002FTenofovir(TDF) and Efavirenz(EFV)\u002FLamivudine\u002FTenofovir Regimens","Comparative Study on Antiviral Efficacy and Safety of Ainuovirine\u002FLamivudine\u002FTenofovir Versus Efavirenz\u002FLamivudine\u002FTenofovir Regimen in HIV Patients With Active Tuberculosis Infection: A Two-stage Prospective Multicenter Clinical Study","ALT VS TLE","Inclusion Criteria:\n\n* Aged between 18 and 65 years;\n* Body weight ≥ 40 kg with BMI ranging from 18.5 to 30 kg\u002Fm²;\n* Treatment-naïve patients with HIV-1 infection who are planned to initiate antiretroviral therapy;\n* Diagnosed with active Mycobacterium tuberculosis infection and receiving anti-tuberculosis regimen containing rifampicin and isoniazid;\n* CD4⁺ T cell count ≥ 25 cells\u002FμL;\n* HIV RNA viral load \\\u003C 500,000 copies\u002FmL;\n* Subjects who can fully understand the nature, methods and potential adverse reactions of this trial, comply with the requirements stated in the informed consent form, and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Subjects with allergic constitution or a history of allergy to the study drugs and excipients;\n* Those with a history of drug addiction, substance abuse, or chronic alcoholism;\n* Pregnant or lactating women; women of childbearing potential who cannot adopt effective contraceptive measures (e.g., contraceptive diaphragm, condom, intrauterine device, partner vasectomy), or whose sexual partners fail to implement effective contraception;\n* Subjects who have used drugs with moderate to high drug drug interaction potential with the study drugs (excluding anti tuberculosis drugs) within 2 weeks prior to formal enrollment and ART initiation (only applicable to the pre trial phase);\n* Those who are unable to receive oral anti tuberculosis treatment during antiretroviral therapy;\n* Subjects with baseline drug resistance test results showing resistance to NNRTIs, 3TC or TDF;\n* Those with resistance to one or more anti tuberculosis drugs;\n* Subjects diagnosed or tentatively diagnosed with tuberculous meningitis;\n* Patients complicated with other severe opportunistic infections besides Mycobacterium tuberculosis infection;\n* Abnormal liver function: alanine transaminase (ALT)\u002Faspartate transaminase (AST) \\> 3×ULN with clinical symptoms, or \\> 5×ULN without symptoms; total bilirubin (TBil) \\> 2×ULN;\n* Impaired renal function: estimated glomerular filtration rate (eGFR) calculated by the CKD EPI formula \\\u003C 60 mL\u002Fmin\u002F1.73 m²;\n* Subjects complicated with tumors, severe neurological or psychiatric diseases, metabolic disorders, gastrointestinal diseases or other comorbidities that, in the investigator's judgment, may affect their participation and completion of the study;\n* Any other conditions deemed inappropriate for enrollment by the investigator.","ALL","18 Years","65 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","This is a prospective, multicenter, open-label, parallel-controlled study. The primary objective is to prospectively explore and compare the virological efficacy of Ainuovirine\u002FLamivudine\u002FTenofovir and Efavirenz\u002FLamivudine\u002FTenofovir regimens combined with rifampicin and isoniazid-based anti-tuberculosis therapy in HIV-infected patients with active tuberculosis.\n\nParticipants are divided into two groups to compare the virological suppression rate and immunological efficacy between the two antiretroviral regimens. All subjects will receive continuous antiretroviral medication and anti-tuberculosis drugs under medical supervision throughout the study.",[28,29,30],"HIV","Art Therapy","TB - Tuberculosis","NOT_YET_RECRUITING","2026-06-01",{"date":34,"type":35},"2026-06-08","ACTUAL",{"date":37,"type":22},"2026-06",{"date":39,"type":22},"2028-12",{"name":41,"class":42},"Shanghai Public Health Clinical Center","OTHER_GOV",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100640753","short-course-regimens-for-ds-ptb-in-aids-patients-100640753","NCT07608172","Short-Course Regimens for DS-PTB in AIDS Patients","A Validation Study of Short-Course Regimens for Drug-Susceptible Pulmonary Tuberculosis in AIDS Patients","Inclusion Criteria:\n\n* Age ≥ 18 years, able to understand and sign the informed consent form.\n* Confirmed HIV infection.\n* Baseline CD4+ T-lymphocyte count \\\u003C 100 cells\u002FμL.\n* Confirmed active pulmonary tuberculosis.\n* Agree to receive antituberculosis treatment and antiretroviral therapy during the study period.\n\nExclusion Criteria:\n\n* Known or suspected resistance to any of the drugs in the regimen, including rifapentine, moxifloxacin, rifampicin, isoniazid, ethambutol, and pyrazinamide.\n* Body weight \\\u003C 40 kg.\n* Received the current tuberculosis treatment for more than 7 days.\n* Complicated with tuberculous meningitis or other severe forms of tuberculosis.\n* Severe liver dysfunction (ALT or AST \\> 5 times the upper limit of normal, ULN). - - Severe renal dysfunction (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²).\n* Baseline electrocardiogram (ECG) showing QTc interval \\> 500 ms.\n* Pregnant or lactating women.\n* Presence of other conditions deemed inappropriate for study participation by the investigators.",{"count":51,"type":22},148,[53],"NA","This study adopts a multicenter, open-label, randomized controlled design, conducted across key designated AIDS diagnosis and treatment hospitals nationwide. It aims to compare the efficacy and safety of the 2HPMZ\u002F2HPM regimen versus the 2HRZE\u002F4HR regimen in treating HIV-associated drug-susceptible pulmonary tuberculosis (DS-TB) among patients with a CD4+ T-cell count \\\u003C 100 cells\u002FμL. A total of 148 participants will be enrolled and randomized 1:1 into two groups: 74 cases in the 2HPMZ\u002F2HPM group and 74 cases in the 2HRZE\u002F4HR group.",[56,57],"Tuberculosis in HIV-infected Individuals","Drug Susceptible Pulmonary Tuberculosis",[59,60,61],"Drug susceptible pulmonary tuberculosis","HIV-infected individuals","2HPMZ\u002F2HPM","2026-05-24",{"date":64,"type":35},"2026-05-27",{"date":66,"type":22},"2026-05-25",{"date":68,"type":22},"2028-12-31",{"name":41,"class":42},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":93,"locationsCount":4},"100639501","enhanced-treatment-strategy-for-disseminated-mac-infection-in-hiv-patients-a-randomized-controlled-trial-100639501","NCT07585461","Enhanced Treatment Strategy for Disseminated MAC Infection in HIV Patients: A Randomized Controlled Trial","A Multicenter, Randomized, Controlled Trial Evaluating the Efficacy and Safety of Adding Fluoroquinolone (Levofloxacin or Moxifloxacin) to Standard Triple Therapy in Disseminated Mycobacterium Avium Complex Infection","Inclusion Criteria:\n\n* Age ≥18 years\n* HIV infection confirmed\n* Disseminated Mycobacterium avium complex (MAC) infection confirmed by positive culture from a sterile site or positive molecular\u002Fsequencing-based detection from a sterile site specimen considered clinically significant\n* Systemic manifestations consistent with disseminated infection\n* Planned initiation of standard antimycobacterial therapy\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Prior effective antimycobacterial treatment for \\>14 days before enrollment\n* Known macrolide resistance, if susceptibility data are available\n* Hypersensitivity to macrolides, ethambutol, rifamycins, or fluoroquinolones\n* Baseline QTc \\>500 ms or history of significant cardiac arrhythmia\n* Uncorrected hypokalemia or hypomagnesemia\n* History of severe adverse reaction to fluoroquinolones, such as tendon rupture or severe neuropathy\n* Severe hepatic impairment or severe renal dysfunction precluding study treatment\n* Concomitant medications that significantly prolong QT interval and cannot be safely discontinued\n* Pregnancy or breastfeeding\n* Coexisting infection requiring non-protocol antimycobacterial therapy, such as active tuberculosis\n* Any condition that, in the investigator's judgment, would interfere with study participation or interpretation of results",{"count":78,"type":22},124,[53],"Background:\n\nDisseminated Mycobacterium avium complex (MAC) infection remains a serious opportunistic infection in patients with advanced HIV infection, particularly among those with severe immunosuppression. Despite the widespread use of antiretroviral therapy (ART), disseminated MAC (DMAC) continues to be associated with significant morbidity and mortality. The current standard treatment consists of a macrolide-based triple regimen, including a macrolide, ethambutol, and rifamycin. However, in patients with high mycobacterial burden or profound immunodeficiency, early microbiological response and clinical improvement are often suboptimal, and treatment is complicated by drug interactions and tolerability issues.\n\nObjective:\n\nThis study aims to evaluate whether adding a fluoroquinolone (levofloxacin or moxifloxacin) to the standard triple therapy improves early clinical outcomes in HIV-infected patients with disseminated MAC infection.\n\nMethods:\n\nThis is a prospective, multicenter, randomized, open-label, controlled trial. A total of 124 adult HIV-infected patients with confirmed disseminated MAC infection will be randomly assigned in a 1:1 ratio to receive either standard triple therapy (macrolide, ethambutol, and rifamycin) or an intensified four-drug regimen with the addition of a fluoroquinolone during the initial 8-week intensive phase. Participants will be followed for at least 24 weeks.\n\nOutcomes:\n\nThe primary endpoint is the clinical symptom resolution rate at Day 28. Secondary endpoints include microbiological outcomes (culture or molecular conversion at Days 28, 56, and 84), time to culture conversion, mortality, relapse, and safety outcomes including adverse events and QT interval prolongation.\n\nSignificance:\n\nThis study will provide prospective evidence on whether an intensified treatment strategy can improve early clinical response and microbiological clearance in disseminated MAC infection, while maintaining an acceptable safety profile. The findings may help optimize treatment strategies for HIV-associated disseminated MAC infection.",[82,83],"Opportunistic Infections, HIV Related","Disseminated Mycobacterium Avium Complex Infection",[85,28,86],"Disseminated MAC","Fluoroquinolone","2026-05-08",{"date":89,"type":35},"2026-05-13",{"date":91,"type":22},"2026-04-30",{"date":68,"type":22},{"name":41,"class":42},{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":103,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},"100639000","phase-1-efficacy-and-safety-of-immune-checkpoint-inhibitors-for-refractory-opportunistic-infections-in-aids-100639000","NCT07579247","Efficacy and Safety of Immune Checkpoint Inhibitors for Refractory Opportunistic Infections in AIDS","A Study on the Efficacy and Safety of Immune Checkpoint Inhibitors in the Treatment of AIDS Complicated With Refractory Opportunistic Infections","Inclusion Criteria:\n\nAge ≥ 18 years. Confirmed HIV-1 infection.\n\nMust have at least one opportunistic infection meeting the \"refractory\" criteria after currently available standard anti-infective treatment, defined as follows:\n\n1. Parvovirus B19: Hemoglobin (Hb) fails to recover (increase \\\u003C10g\u002FL) or requires transfusion maintenance, with reticulocytes persistently \\\u003C1% after 4 weeks of Intravenous Immunoglobulin (IVIG) therapy.\n2. Cytomegalovirus (CMV): Blood\u002Fbody fluid CMV-DNA decrease \\\u003C1 log10 or new\u002Fworsening organ damage after 2 weeks of Ganciclovir or Foscarnet therapy.\n3. Mpox virus: Unhealed lesions, new lesions, necrotic coalescence, or no decrease in viral load after 14 days of Tecovirimat, Cidofovir, or Brincidofovir therapy.\n4. Progressive Multifocal Leukoencephalopathy (PML): Continuous deterioration of neurological symptoms or expanded lesion area on MRI after 3 months of optimized antiretroviral therapy (ART).\n5. Pneumocystis jirovecii pneumonia (PCP): No improvement in oxygenation index or expanded radiological lesions after 8 days of adequate SMZ-TMP therapy.\n6. Cryptococcal meningitis: Persistently positive cerebrospinal fluid (CSF) culture after 4 weeks of induction therapy.\n7. Talaromyces marneffei \u002F Invasive Aspergillosis: Persistently positive culture or progression of radiological\u002Fclinical symptoms after 2 weeks of Amphotericin B or Voriconazole therapy.\n8. Mycobacterium tuberculosis (TB): Persistently positive sputum smear or culture after 2 months of standard anti-tuberculosis therapy.\n9. Nontuberculous mycobacteria (NTM): No improvement in clinical symptoms after 1 month of standard therapy, or culture not turning negative after 3 months.\n\nHigh PD-1 expression on peripheral CD8+ T cells (\\>25%) OR weak pathogen-specific ELISpot response (\\\u003C50 SFCs\u002F10\\^6 cells).\n\nAgreement to use highly effective contraception during the study and for 6 months after the end of the trial.\n\nVoluntary signing of informed consent.\n\nExclusion Criteria:\n\nHistory of active autoimmune disease or autoimmune disease requiring systemic treatment.\n\nPrior organ transplantation or hematopoietic stem cell transplantation. Pregnant or lactating women. Known allergy or anti-drug antibodies to the study drug or its excipients. Prior treatment or exposure to any other immune checkpoint inhibitors. Received immunomodulatory or immunosuppressive therapy (excluding glucocorticoids) within 24 weeks prior to the first dose of the study drug.\n\nPsychiatric disorders or substance abuse that may interfere with the trial. Other severe medical conditions deemed by the investigator as unsuitable for trial participation (e.g., uncontrolled severe heart, liver, or renal failure).",{"count":102,"type":22},50,[104,105],"PHASE1","PHASE2","This prospective, single-arm, open-label study aims to evaluate the efficacy and safety of a PD-1 inhibitor (Sintilimab) combined with standard anti-infective therapy in patients with advanced HIV disease (AHD) who are suffering from refractory opportunistic infections (OIs).\n\nDespite effective antiretroviral therapy (ART), some HIV patients develop severe, hard-to-treat infections (such as CMV, PCP, Tuberculosis, etc.) that do not respond to standard antimicrobial treatments. This is often due to a condition called \"immune exhaustion,\" where the body's infection-fighting T-cells become inactive and express high levels of a protein called PD-1.\n\nSintilimab is an immune checkpoint inhibitor that blocks PD-1, effectively \"waking up\" the exhausted T-cells. While traditionally used for cancer, recent evidence suggests it can safely restore the immune system's ability to clear stubborn infections in HIV patients. In this study, eligible patients with refractory OIs and evidence of immune exhaustion will receive Sintilimab (200 mg intravenously every 3 weeks for a total of 3 doses) alongside their regular treatments. Researchers will monitor patient safety, clinical improvement, and immunological recovery.",[28,108,109,110],"AIDS","Immune Checkpoint Inhibitors","Refractory Opportunistic Infection","2026-05-06",{"date":113,"type":35},"2026-05-12",{"date":115,"type":22},"2026-05",{"date":117,"type":22},"2029-12",{"name":41,"class":42},1,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":23,"phases":128,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":142,"locationsCount":4},"100636433","prevention-of-aids-with-opportunistic-infection-paradoxical-iris-100636433","NCT07565623","Prevention of AIDS With Opportunistic Infection Paradoxical IRIS","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Confirmed HIV infection;\n* Presence of HIV-related opportunistic infection(s), including non-tuberculous -mycobacterial infection, PJP, pneumonia, cryptococcal meningitis, Talaromyces marneffei infection, CMV retinitis, or PML;\n* Baseline CD4 T-lymphocyte count \\\u003C 100 cells\u002FμL;\n* Planned initiation of antiretroviral therapy;\n* Willing to participate in this study, able to comply with all follow-up requirements, and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Presence of Kaposi sarcoma, pregnancy, or confirmed tuberculosis;\n* Body weight \\\u003C 40 kg;\n* Severe hepatic dysfunction (ALT or AST \\> 5 times the upper limit of normal, ULN);\n* Severe renal dysfunction (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²);\n* Baseline electrocardiogram (ECG) showing a QTc interval \\> 500 ms;\n* Pregnant or lactating women;\n* Contraindications to glucocorticoid use;\n* Any other condition considered by the investigators to be unsuitable for participation in this study.",{"count":127,"type":22},131,[53],"This study was a multicenter, open-label, randomized controlled clinical trial designed to evaluate the efficacy and safety of glucocorticoids in preventing paradoxical immune reconstitution inflammatory syndrome (IRIS) in patients with AIDS complicated by opportunistic infections. A total of 262 HIV-infected patients with a baseline CD4⁺ T-cell count \\\u003C100\u002FμL, who were scheduled to initiate antiretroviral therapy and had opportunistic infections, were enrolled and randomly assigned in a 1:1 ratio to the prednisolone group or the control group. Participants in the treatment group received prednisolone at 40 mg\u002Fday for 14 days followed by 20 mg\u002Fday for 14 days, whereas the control group received no glucocorticoid intervention. All participants were followed for 12 weeks. The primary endpoint was the incidence of paradoxical IRIS within 12 weeks. Secondary endpoints included time to IRIS onset, duration of IRIS, mortality, hospitalization, serious adverse events, CD4⁺ T-cell counts, and HIV-RNA suppression. The findings will provide evidence-based support for the prevention of paradoxical IRIS.",[131,132],"HIV (Human Immunodeficiency Virus)","IRIS",[28,132,134,135],"prevention","glucocorticoid","2026-04-29",{"date":138,"type":35},"2026-05-04",{"date":140,"type":22},"2026-05-01",{"date":68,"type":22},{"name":41,"class":42},{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":149,"targetDuration":151,"studyType":152,"phases":4,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":159,"leadSponsor":161,"locationsCount":4},"100633413","real-world-cohort-study-of-antiretroviral-therapy-in-hiv-patients-with-opportunistic-infections-100633413","NCT07526363","Real-world Cohort Study of Antiretroviral Therapy in HIV Patients With Opportunistic Infections","Inclusion Criteria:\n\n* For the opportunistic infection treatment group: Inclusion criteria: a) Age ≥ 18 years, diagnosed with HIV-1 infection; b) Clinically diagnosed with one of the following opportunistic infections and initiating anti-infective therapy: PCP, tuberculosis, NTM infection, CMV infection, herpes simplex virus and varicella-zoster virus infection, toxoplasmosis encephalopathy, oral fungal infection, cryptococcal meningitis, Marneffei basket disease, PML; c) Intending to initiate ART therapy or currently receiving ART therapy; d) The individual (or their legal representative) voluntarily signs a written informed consent form.\n* For the non-opportunistic infection group: a) Age ≥ 18 years, diagnosed with HIV-1 infection; b) Intending to start ART treatment or currently receiving ART treatment; c) The individual (or legal representative) voluntarily signs a written informed consent form.\n\nExclusion Criteria:\n\n* For the opportunistic infection treatment group: Exclusion criteria: a) Individuals suffering from major neurological or psychiatric illnesses such as schizophrenia, epilepsy, or severe depression; b) Individuals with a history of drug use or recent history of alcohol or drug dependence; c) Individuals deemed unsuitable for participation by researchers, such as those in the acute phase of severe cardiovascular disease; d) Individuals deemed unsuitable for participation by other researchers; e) Individuals whose long-term follow-up requirements and frequency cannot be guaranteed.\n* For the non-opportunistic infection group: a) Individuals with coexisting opportunistic infections; b) Individuals suffering from major neurological or psychiatric illnesses such as schizophrenia, epilepsy, or severe depression; c) Individuals with a history of drug use or recent history of alcohol or drug dependence; d) Individuals deemed unsuitable for participation by researchers, such as those in the acute phase of severe cardiovascular disease; e) Individuals deemed unsuitable for participation by other researchers; f) Individuals whose long-term follow-up requirements and frequency cannot be guaranteed.",{"count":150,"type":22},8000,"30 Months","OBSERVATIONAL","This study stratified and compared the differences in virological efficacy and sustained viral suppression status between HIV-infected patients with and without opportunistic infections, providing a basis for optimizing antiretroviral therapy for opportunistic infections and a data foundation for establishing predictive models.",[82],"2026-04-06",{"date":157,"type":35},"2026-04-13",{"date":140,"type":22},{"date":160,"type":22},"2029-06-01",{"name":41,"class":42},{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":23,"phases":172,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":181,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":119},"100292964","phase-1-clinical-safty-and-efficacy-study-of-infusion-of-inkt-cells-and-cd8t-cells-in-patients-with-advanced-solid-tumor-100292964","NCT03093688","Clinical Safty and Efficacy Study of Infusion of iNKT Cells and CD8+T Cells in Patients With Advanced Solid Tumor","Phace I and II Study of Immunotherapy Strategy Used iNKT Cells and CD8+T Cells in Patients With Advanced Tumor","Inclusion Criteria:\n\n* Histological or cytologically diagnosis of advanced lung cancer, or advanced gastric cancer, or advanced pancrease cancer, or hepatocellular carcinoma, or advanced colorectal cancer\n* Patients' tumor tissue (formalin-fixed, paraffin-embedded) must be sufficient for diagnosis of cancer by a certified Laboratory of Pathology\n* Laboratory values within the following ranges prior to receiving treatment of study agent: Hemoglobin≧8.0 g\u002FdL, Neutrophils count≧1E9\u002FL, Lymphocytes count≧lower limit of institutional normal, Platelet count≧50E9\u002FL, Serum creatinine≦2.0 mg\u002FdL, Serum bilirubin≦2 x upper limit of institutional normal, AST\u002FALT≦2 x upper limit of institutional normal\n* No dyspnea at rest. Oxygen saturation ≥90% on room air\n* No genetic disease\n* Fertile females\u002Fmales must consent to use contraceptives during participation of the trial. Women of child bearing potential must have a negative pregnancy test prior to receiving treatment of study agent within 7 days\n* Patients must have a Karnofsky performance status greater than or equal to 80%\n* Able and willing to give witnessed, written informed consent form prior to receiving any study related procedure\n* Agrees to participate in long-term follow-up for up to 1 years, if received NKT infusion\n\nExclusion Criteria:\n\n* Organ dysfunction,such as significant cardiovascular disease, myocardial infarction within the past six months, unstable angina, coronary angioplasty within the past six months, uncontrolled atrial or ventricular cardiac arrhythmias; Child-Pugh C; Renal function failure or uremia; Respiratory failure; Disturbance of consciousness; Renal failure.\n* Suffering from lymphoma or leukemia\n* Serious infections requiring antibiotics, bleeding disorders\n* Patients with myelodysplastic syndrome (MDS)\n* History of immunodeficiency disease or autoimmune disease\n* Positive HIV antigen and antibody, Hepatitis B surface antigen and Hepatitis C PCR within 21 days prior to enrollment\n* Within concurrent chemotherapy\n* Concurrent other medical condition that would prevent the patient from undergoing protocol-based therapy\n* Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent\n* Pregnant or breast-feeding patients\n* Can't give informed consent\n* Lack of availability for follow-up assessment","70 Years",{"count":171,"type":22},40,[104,105],"Invariant Natural killer T (iNKT) cells are a unique subset of lymphocytes that express homogeneous TCR recognizing KRN7000 which was up-regulated by many kinds of cancer cells. PD-1+CD8+T cells of patients with advanced tumor are most likely tumor-specified. Our hypothesis is that immunotherapy strategy of infusion of iNKT cells and PD-1+CD8+T cells may decrease the tumor burden and improve overall survival. The purpose of this study is to assess the safety and efficacy of treatment of patients with advanced solid tumor by infusing of iNKT cells and PD-1+CD8+T cells.",[175,176,177,178,179,180],"Non-small Cell Lung Cancer","Small Cell Lung Cancer","Pancreas Cancer","Hepatocellular Carcinoma","Gastric Cancer","Renal Cell Carcinoma","RECRUITING","2025-06-29",{"date":184,"type":35},"2025-07-02",{"date":186,"type":35},"2017-03-01",{"date":188,"type":22},"2030-12-31",{"name":41,"class":42},{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":23,"phases":198,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":210,"locationsCount":4},"100587298","single-high-dose-of-liposomal-amphotericin-b-in-combination-with-bftaf-for-hivaids-associated-talaromycosis-100587298","NCT06926569","Single High-dose of Liposomal Amphotericin B in Combination With B\u002FF\u002FTAF for HIV\u002FAIDS-associated Talaromycosis","Inclusion Criteria:\n\n1. Aged 18 and above\n2. ART naive\n3. HIV positive individuals\n4. Confirmed Talaromycosis diagnosed by culture\u002Fmicroscopy\n\nExclusion Criteria:\n\n1. Pregnancy or lactating women;\n2. Central nervous system involvement (assessed either through clinical manifestations or cerebrospinal fluid analysis);\n3. Known allergy to AMB d\u002FL-AMB, or the concomitant use of medications known to interact with AMB d\u002FL-AMB;\n4. Alanine aminotransferase or aspartate aminotransferase levels exceeding 400 U\u002FL;\n5. Absolute neutrophil count below 500\u002Fmm3;\n6. Creatinine clearance below 30 mL\u002Fmin (calculated using the Cockcroft and Gault equation);\n7. Concurrent diagnosis of cryptococcal meningitis;\n8. Concurrent treatment with rifampicin;\n9. Previous treatment for talaromycosis lasting more than 48 hours.",{"count":197,"type":22},116,[53],"This study aims to compare the efficacy and safety of a single high-dose Liposomal Amphotericin B (L-AMB) against conventional Amphotericin B deoxycholate (AmBD) for HIV-associated Talaromycosis.\n\nThe investigators hypothesize that L-AMB induction therapy (10 mg\u002Fkg) is non-inferior to AmBD (0.5-0.7 mg\u002Fkg\u002Fd) in efficacy and has an improved safety profile.\n\nThe study's primary objective is to provide evidence supporting the guideline recommendation of single high-dose L-AMB for HIV-infected individuals with talaromycosis, while validating L-AMB's efficacy and safety in China.\n\nStudy Design: Multi-center, randomized controlled trial comparing single high-dose L-AMB to guideline-recommended AmBD induction therapy for HIV-associated talaromycosis. Participants are HIV-infected adults (≥18 years) with confirmed talaromycosis by microscopy or culture.\n\nInterventions:\n\n1. L-AMB group receives a single intravenous dose of 10 mg\u002Fkg L-AMB.\n2. Control group receives intravenous AmBD at 0.5-0.7 mg\u002Fkg\u002Fd for 14 days.\n3. Both groups start consolidation therapy with itraconazole 200mg q12h for 10 weeks within 24 hours post-induction.\n4. Secondary prophylaxis with itraconazole 200mg qd until CD4+ cell counts exceed 100cells\u002Fmm³ for at least 6 months.\n5. All start B\u002FF\u002FTAF qd within 7 days post-antifungal therapy.\n\nPrimary Objective： This multicenter study compares efficacy\u002Fsafety of single high-dose L-AMB vs standard AmBD (2-week) induction for HIV-associated talaromycosis, generating evidence to support L-AMB guidelines in Chinese populations.\n\nSecondary Objectives： Evaluate feasibility\u002Fsafety of initiating B\u002FF\u002FTAF within 7 days post-antifungal therapy, providing evidence for rapid ART guidelines in these patients.\n\nEndpoints:\n\n* Primary: Proportion achieving clinical resolution on day 14.\n* Secondary: Overall survival, renal function, anemia, liver function, adverse events grade 3 or higher on day 14; time to clinical resolution and sterile blood cultures; survival, HIV viral suppression, CD4+ T-cell counts, adverse events (including IRIS), ART persistency, and patient-reported outcomes at weeks 4, 12, and 24.\n\nSample Size: 58 participants per group (116 total), considering a 10% dropout rate.",[201],"HIV\u002FAIDS-associated Talaromycosis",[203],"HIV\u002FAIDS-associated talaromycosis","2025-04-07",{"date":206,"type":35},"2025-04-13",{"date":208,"type":22},"2025-05-01",{"date":140,"type":22},{"name":41,"class":42},{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":218,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":219,"targetDuration":4,"studyType":23,"phases":220,"briefSummary":222,"conditions":223,"keywords":225,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":119},"100575162","early-phase-1-safety-and-immunogenicity-evaluation-of-the-recombinant-flagellin-protein-adjuvant-100575162","NCT06768697","Safety and Immunogenicity Evaluation of the Recombinant Flagellin Protein Adjuvant","Safety and Immunogenicity Evaluation of the Recombinant Flagellin Protein Adjuvant in the SARS-CoV-2 Subunit Mucosal Vaccine","Inclusion Criteria:\n\n1. The subjects are healthy individuals aged between 18 and 65 years old (inclusive), with no gender preference, ensuring an appropriate gender ratio.\n2. Have received 2-3 doses of COVID-19 inactivated vaccine, and the last dose was administered more than 6 months ago.\n3. Have not been infected with COVID-19 within 3 months.\n4. Capable of being used in conjunction with nasal sprays, and also suitable for nasal irrigation, saliva collection, and blood collection.\n5. Male subjects and their partners, or female subjects, must agree to adopt one or more non-drug contraceptive measures (such as complete abstinence, condoms, intrauterine devices, partner sterilization, etc.) during the trial period and for six months after the trial ends, and they must not have plans for sperm donation or egg donation.\n6. The subjects fully understand the purpose, nature, methods, and possible adverse reactions of the trial, voluntarily participate in the trial, and sign the informed consent form.\n7. The subject is able to communicate effectively with the researcher and complete the study in accordance with the protocol.\n\nExclusion Criteria:\n\n1. Active or suspected viral, bacterial, fungal, or parasitic infections, including herpes, shingles, or cold sores, within 14 days prior to screening.\n2. History of recurrent infections of unknown causes; or use of systemic antibiotics within 90 days prior to drug administration.\n3. Individuals with malignant tumors or a history of malignant tumors, except for non-melanoma skin cancer that has been cured for more than 3 years.\n4. Nasal malformation, trauma, or other reasons that make it impossible to use nasal sprays.\n5. Individuals with a history of allergy to biological agents or any drug components; individuals with a history of allergies, such as asthma, aspergillus infection, allergic rhinitis, etc., who have been determined by researchers to be unsuitable for enrollment.\n6. Screen for outpatient or inpatient history of clinically significant chronic or acute disease symptoms within the previous 3 months, and ensure no surgical plans during the study period.\n7. Previous tests have found HIV-Ab positive, HCV positive, and anti-syphilis helical-specific antibody positive (please consult the subject).\n8. Individuals with abnormal vital signs (refer to normal range: systolic blood pressure 90\\~139mmHg, diastolic blood pressure 60\\~89mmHg, pulse rate 55-100 beats\u002Fmin; body temperature (ear temperature) 35.4-37.7℃; respiratory rate 16-20 breaths\u002Fmin) or abnormal electrocardiogram (QTcB≥450 ms, QTcB= QT\u002FRR0.5) or clinically significant abnormalities in physical examination, laboratory tests (subject to the judgment of the clinical research doctor).\n9. Screen for the use of other medications, including prescription or non-prescription drugs, and herbal remedies, within the previous 4 weeks.\n10. Screen for individuals who have received vaccination within the previous 4 weeks or plan to receive vaccination during the study period.\n11. Individuals with a history of significant allergic reactions (anaphylaxis or angioedema) to any products (such as food and drugs), and known to be allergic to the test drug, its excipients, or similar drugs.\n12. Participate in any other drug clinical trials within 3 months before screening or within 5 half-lives of other clinical trial drugs (choose the longer time period).\n13. Exclude individuals who have donated plasma or whole blood exceeding 200 mL within the previous 3 months, except during menstruation.\n14. Individuals who abuse drugs or have used soft drugs (such as marijuana) within the past 3 months, or have consumed hard drugs (such as cocaine, phencyclidine, etc.) within the year prior to the trial; or individuals who test positive for drug abuse in urine screening (including methamphetamine, ketamine, MDMA, marijuana, morphine).\n15. Individuals who are alcoholics or have regularly consumed alcohol within the 6 months prior to the trial, with an average weekly alcohol intake exceeding 14 units (1 unit of alcohol is equivalent to approximately 360 mL of beer, 45 mL of spirits with a 40% alcohol content, or 150 mL of wine), or those who cannot abstain from alcohol during the trial period (interview).\n16. Subjects who have smoked an average of more than 5 cigarettes per day or used other nicotine-containing products (such as nicotine patches, nicotine gum, e-cigarettes, etc.) more than 5 times per day on average within the previous 3 months, or who cannot stop using any tobacco-related products during the trial period.\n17. Those who have previously or currently suffered from any clinically severe diseases of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry, or metabolic abnormalities, or any other diseases that may interfere with the results of the trial.\n18. Use other medications, including prescription or non-prescription drugs, and Chinese herbal medicine, from the screening date to D1.\n19. Women who are pregnant, breastfeeding, or may become pregnant.\n20. Clinical diagnosis of any autoimmune disease or rheumatic disease.\n21. The patient's blood COVID-19 specific IgG antibody is greater than 1×10e4.\n22. Any situation that other researchers consider unsuitable for participation in the study.\n\n    \\-",true,{"count":21,"type":22},[221],"EARLY_PHASE1","The goal of this clinical trial is to learn if the SARS-CoV-2 subunit mucosal vaccine with the recombinant flagellin protein adjuvant works to Prevent COVID-19 infection. It will also learn about the Safety and immunogenicity of the vaccine.",[224],"COVID - 19",[226,227,228,229,230],"adjuvant","novel adjuvant","flagellin","mucosal vaccine","SARS-CoV-2","2025-01-06",{"date":233,"type":35},"2025-01-10",{"date":235,"type":22},"2024-12-30",{"date":237,"type":22},"2025-12-30",{"name":41,"class":42},{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":246,"enrollmentInfo":247,"targetDuration":4,"studyType":23,"phases":249,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":259,"locationsCount":4},"100477208","phase-4-efficacy-and-tolerability-of-dtg-plus-3tc-in-hiv-infected-adults-with-virologically-suppression-and-tdf-toxicity-100477208","NCT05493969","Efficacy and Tolerability of DTG Plus 3TC in HIV Infected Adults With Virologically Suppression and TDF Toxicity","A Study Evaluating the Efficacy and Tolerability of Dolutegravir Plus Lamivudine in HIV Infected Adults Who Are Virologically Suppressed and With Evidence of TDF Toxicity","Inclusion Criteria:\n\n1. Female subjects were required to meet one of the following criteria: 1) Incapacitated, defined as postmenopausal (spontaneous amenorrhea at 12 months, age ≥45 years) or physically unable to conceive after tubal ligation, hysterectomy, or bilateral oophorectomy; 2) Have potential to have children, but are negative at screening and on day 1 pregnancy test, and agree to use appropriate contraceptive methods, including oral contraceptives, condoms and intrauterine devices;\n2. At least once plasma HIV-1 RNA\\\u003C40 c\u002FmL in the 6 months prior to screening and plasma HIV-1 RNA \\\u003C40 c\u002FmL at screening;\n3. Must be on uninterrupted TDF + 3TC\u002FFTC-based regimen for ≥6 months prior to screening;\n4. Participants with pre-existing clinical manifestations of TDF related adverse reactions at the time of screening.\n\n   TDF-related renal damage was defined as: meeting 1 of the 5 following conditions in the investigator's judgement, based upon the medical history and relevant examinations, likely to represent TDF toxicity:\n\n   i. eGFR decrease by 5 mL\u002Fmin per year for at least 3 consecutive years or confirmed 25% eGFR decline from baseline ii. Urine β2-microglobulin\u002FCr ≥300 μg\u002Fg iii. Urine microalbumin\u002Fcreatinine \\>30 μg\u002Fmg iv. Non-diabetic glycosuria (urine glucose 1+ or above) v. Serum phosphate \\\u003C0.8 mmol\u002FL TDF - associated bone toxicity is defined as a T-value less than -1.0 or Z- value less than -2.0 or fragility fracture after TDF\u002FXTC use and other factors is excluded according to the medical history and relevant examination.\n5. Sign the informed consent and be able to visit regularly according to the test requirements.\n\nExclusion Criteria:\n\n1. Women who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study;\n2. Participants with AIDS-related opportunistic infections or AIDS-related or unrelated neoplastic diseases;\n3. Patients with ALT \\>= 5 x ULN, or ALT \\>=3 x ULN and bilirubin \\>= 1.5xULN (with \\>35% direct bilirubin. Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).\n4. Evidence of Hepatitis B virus (HBV) infection: Participants positive for HBsAg, negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.\n5. Hepatitis C virus (HCV) infection;\n6. Participants who are allergic or intolerant to lamivudine or dolutegravir;\n7. Participants with known previous episodes of virologic failure and known resistance mutations of 3TC or INSTI if resistance mutations had previously been identified;\n8. Taking medications that contraindicated with lamivudine or dolutegravir; Other conditions that the investigator considers unsuitable to participate in the study, including the risk of suicide, poor adherence, and interference with the evaluation of clinical study endpoints.\n9. Participants with creatinine clearance \\\u003C30ml\u002Fmin.","75 Years",{"count":248,"type":22},100,[25],"To investigate the efficacy and tolerability of the regimen of dolutegravir plus lamivudine in HIV infected adults who are virologically suppressed and with evidence of TDF toxicity.",[252],"Acquired Immunodeficiency Syndrome","2022-08-06",{"date":255,"type":35},"2022-08-09",{"date":257,"type":22},"2022-08",{"date":37,"type":22},{"name":41,"class":42},""]