[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623110":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":47,"centralContacts":51,"locations":58,"responsibleParty":122,"collaborators":38,"id":124,"slug":38,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":38,"eligibilityCriteria":129,"healthyVolunteers":130,"sex":131,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":38,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":74,"whyStopped":38,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"BioNTech SE","INDUSTRY",[8,15,19,22,25,29],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A - Cohort A1","EXPERIMENTAL","PLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (2:1)",[13,14],"Drug: BNT351","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Part A - Cohort A2","PLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (3:1)",[13,14],{"label":20,"type":10,"description":17,"interventionNames":21},"Part A - Cohort A3",[13,14],{"label":23,"type":10,"description":17,"interventionNames":24},"Part A - Cohort A4",[13,14],{"label":26,"type":10,"description":27,"interventionNames":28},"Part B - Cohort B1","PLWH will receive BNT351 at a protocol-defined dose level. cART will start 56 days post-BNT351 dosing or earlier.",[13],{"label":30,"type":10,"description":27,"interventionNames":31},"Part B - Cohort B2",[13],[33,39,42,45],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","BNT351","IV infusion",[16,20,23,26,30],null,{"type":34,"name":40,"description":36,"armGroupLabels":41,"otherNames":38},"Placebo",[16,20,23],{"type":34,"name":35,"description":43,"armGroupLabels":44,"otherNames":38},"SC injection",[9],{"type":34,"name":40,"description":43,"armGroupLabels":46,"otherNames":38},[9],[48],{"name":49,"affiliation":5,"role":50},"BioNTech Response Person","STUDY_DIRECTOR",[52],{"name":53,"role":54,"phone":55,"phoneExt":56,"email":57},"BioNTech clinical trials patient information","CONTACT","+49 6131 9084","0","patients@biontech.de",[59,72,83,93,102,112],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":38},"Cook County Health","NOT_YET_RECRUITING","Chicago","Illinois","60612","United States",{"type":67,"coordinates":68},"Point",[69,70],-87.65005,41.85003,{"lat":70,"lon":69},{"facility":73,"status":74,"city":75,"state":76,"zip":77,"country":65,"cosmosGeoPoint":78,"geoPoint":82,"contacts":38},"Johns Hopkins","RECRUITING","Baltimore","Maryland","21205-1832",{"type":67,"coordinates":79},[80,81],-76.61219,39.29038,{"lat":81,"lon":80},{"facility":84,"status":61,"city":85,"state":86,"zip":87,"country":65,"cosmosGeoPoint":88,"geoPoint":92,"contacts":38},"Washington University","St Louis","Missouri","63110",{"type":67,"coordinates":89},[90,91],-90.19789,38.62727,{"lat":91,"lon":90},{"facility":94,"status":61,"city":95,"state":95,"zip":96,"country":65,"cosmosGeoPoint":97,"geoPoint":101,"contacts":38},"Columbia University","New York","10032",{"type":67,"coordinates":98},[99,100],-74.00597,40.71427,{"lat":100,"lon":99},{"facility":103,"status":74,"city":104,"state":38,"zip":105,"country":106,"cosmosGeoPoint":107,"geoPoint":111,"contacts":38},"UK Köln","Cologne","50937","Germany",{"type":67,"coordinates":108},[109,110],6.95,50.93333,{"lat":110,"lon":109},{"facility":113,"status":114,"city":115,"state":38,"zip":116,"country":106,"cosmosGeoPoint":117,"geoPoint":121,"contacts":38},"CRS Mannheim","ACTIVE_NOT_RECRUITING","Mannheim","68167",{"type":67,"coordinates":118},[119,120],8.46694,49.4891,{"lat":120,"lon":119},{"type":123,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100623110",false,"NCT07392372","A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV","A Phase I First-in-human Clinical Trial to Evaluate the Safety, Pharmacokinetics, and Antiviral Activity of the Broadly Neutralizing Antibody BNT351 in Adults Living Without and With HIV","Key Inclusion Criteria\n\nPart A:\n\n* Are HIV-1 and HIV-2 negative at Visit 0.\n* Starting at Visit 0 and continuously until the last planned visit in this study are individuals who:\n\n  1. Are assessed by the investigator as having a low likelihood of acquiring HIV and are committed to avoiding behaviors associated with a higher likelihood of acquiring HIV until the End of Study Visit.\n  2. Agree to discuss HIV disease risks;\n  3. Agree to HIV acquisition risk reduction counseling;\n\nPart B:\n\n* Are HIV-1 positive and HIV-2 negative at Visit 0.\n* Individuals who at Visit 0:\n\n  1. Are cART-naïve individuals who were diagnosed with HIV-1 infection ≤12 months prior to screening, OR are individuals who have discontinued cART and who were diagnosed with HIV-1 infection ≤12 months prior to screening or ≤18 months if this is found to be acceptable after discussion on a case-by-case basis with the sponsor's medical monitor.\n  2. If cART-experienced, have discontinued cART for at least 4 weeks before screening (if the individual was taking long-acting antiretroviral therapy \\[ART\\]), see the following bullet). For individuals who have discontinued cART: Are able to comply with study procedures and assessments in the investigator's judgment.\n  3. Have never received lenacapavir or ibalizumab or fostemsavir, and have not received other long-acting ARTs in the last 6 months (i.e., intramuscular cabotegravir, cabotegravir-rilpivirine).\n  4. Have a CD4+ T cell count of ≥500 cells\u002FµL and plasma HIV-1 RNA levels between 5,000-100,000 copies\u002FmL at screening.\n  5. Are willing to initiate cART at a protocol-defined timepoint (56 days post-dose, or earlier if meeting early cART start criteria or at investigator's discretion).\n  6. Are willing to undergo HIV transmission risk reduction counseling and to maintain low-risk behavior to protect their partners.\n\nKey Exclusion Criteria:\n\nParts A and B:\n\n* Have received an HIV vaccination or HIV broadly neutralizing antibody in another clinical study.\n* Have a known or suspected impairment\u002Falteration of immune function or immunodeficiency (except for HIV infection, applicable to Part B only), including receipt of any immunostimulant, immunomodulator, immunosuppressive medication, immunoglobulin, blood product, or oral or parenteral steroid within 60 days prior to Day 1 or planned administration during the study. The following exception applies: Use of inhaled, intranasal, topical, or locally injected corticosteroids (e.g., intraarticular or intrabursal administration) is allowed.\n* Have a history of generalized urticaria or angioedema, or of allergy, anaphylaxis, hypersensitivity or intolerance to a human or humanized antibody or to BNT351 excipients.\n\nPart B only:\n\n* Are receiving ongoing therapy for Mycobacterium tuberculosis infection.\n* Have a history of opportunistic infections\u002FAIDS-defining illnesses as defined in the protocol.\n* Have a history of multi-class drug resistant HIV-1 infection defined as resistance to three or more classes of HIV drugs.\n* Have a history of malignancy within 5 years before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered in the investigator's judgment to have minimal risk of recurrence. Any malignancy that is an AIDS-defining illness (as defined in the protocol) is exclusionary regardless of the perceived risk of recurrence.\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria apply.",true,"ALL","18 Years","65 Years",{"count":135,"type":136},67,"ESTIMATED","INTERVENTIONAL",[139],"PHASE1","This study will test the safety and blood levels of the antibody BNT351 in people living without and with human immunodeficiency virus (HIV). This study will also test the anti-viral activity of BNT351 in people living with HIV (PLWH) with detectable virus levels.\n\nThe main goals of this study are:\n\n* To learn about the safety of BNT351 and check for side effects.\n* To measure the amount of BNT351 antibody in blood over time.\n* To test the amount of HIV in the blood at different times after treatment with BNT351 in people living with HIV.",[142],"HIV -1 Infection",[144,145,146],"HIV-1","Treatment of HIV-1 infection","Antibody","2026-06-18",{"date":149,"type":150},"2026-06-22","ACTUAL",{"date":152,"type":150},"2026-02-09",{"date":154,"type":136},"2027-06",{"name":5,"class":6},6]