[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623110":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":47,"centralContacts":51,"locations":58,"responsibleParty":124,"collaborators":38,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":38,"eligibilityCriteria":132,"healthyVolunteers":133,"sex":134,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":38,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":75,"whyStopped":38,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"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",[59,73,84,94,103,114],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":38},"Cook County Health","NOT_YET_RECRUITING","Chicago","Illinois","60612","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-87.65005,41.85003,{"lat":71,"lon":70},{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":65,"countryCode":66,"cosmosGeoPoint":79,"geoPoint":83,"contacts":38},"Johns Hopkins","RECRUITING","Baltimore","Maryland","21205-1832",{"type":68,"coordinates":80},[81,82],-76.61219,39.29038,{"lat":82,"lon":81},{"facility":85,"status":61,"city":86,"state":87,"zip":88,"country":65,"countryCode":66,"cosmosGeoPoint":89,"geoPoint":93,"contacts":38},"Washington University","St Louis","Missouri","63110",{"type":68,"coordinates":90},[91,92],-90.19789,38.62727,{"lat":92,"lon":91},{"facility":95,"status":61,"city":96,"state":96,"zip":97,"country":65,"countryCode":66,"cosmosGeoPoint":98,"geoPoint":102,"contacts":38},"Columbia University","New York","10032",{"type":68,"coordinates":99},[100,101],-74.00597,40.71427,{"lat":101,"lon":100},{"facility":104,"status":75,"city":105,"state":38,"zip":106,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":113,"contacts":38},"UK Köln","Cologne","50937","Germany","DE",{"type":68,"coordinates":110},[111,112],6.95,50.93333,{"lat":112,"lon":111},{"facility":115,"status":116,"city":117,"state":38,"zip":118,"country":107,"countryCode":108,"cosmosGeoPoint":119,"geoPoint":123,"contacts":38},"CRS Mannheim","ACTIVE_NOT_RECRUITING","Mannheim","68167",{"type":68,"coordinates":120},[121,122],8.46694,49.4891,{"lat":122,"lon":121},{"type":125,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100623110","phase-1-a-clinical-trial-investigating-the-safety-and-biological-activity-of-the-antibody-bnt351-in-adults-living-without-and-with-hiv-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":138,"type":139},67,"ESTIMATED","INTERVENTIONAL",[142],"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.",[145],"HIV -1 Infection",[147,148,149],"HIV-1","Treatment of HIV-1 infection","Antibody","2026-06-18",{"date":152,"type":153},"2026-06-22","ACTUAL",{"date":155,"type":153},"2026-02-09",{"date":157,"type":139},"2027-06",{"name":5,"class":6},6]