[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100423859":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":44,"centralContacts":37,"locations":48,"responsibleParty":147,"collaborators":37,"id":149,"slug":150,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":37,"eligibilityCriteria":155,"healthyVolunteers":151,"sex":156,"minAge":157,"maxAge":158,"enrollmentInfo":159,"targetDuration":37,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":169,"whyStopped":37,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},{"fullName":5,"class":6},"AbbVie","INDUSTRY",[8,14,19,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: Placebo SC + Placebo IV","EXPERIMENTAL","Participants will receive Subcutaneous (SC) Placebo, followed by Intravenous (IV) Placebo.",[13],"Drug: Placebo",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2: Budigalimab (SC) + Placebo IV","Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo.",[18,13],"Drug: Budigalimab",{"label":20,"type":10,"description":16,"interventionNames":21},"Group 3: Budigalimab SC + Placebo IV",[18,13],{"label":23,"type":10,"description":24,"interventionNames":25},"Group 4: Placebo SC + Budigalimab IV","Participants will receive Subcutaneous (SC) Placebo, followed by IV Budigalimab.",[13,18],[27,34,38,42],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Budigalimab","Subcutaneous (SC)",[15,20],[33],"ABBV-181",{"type":28,"name":35,"description":30,"armGroupLabels":36,"otherNames":37},"Placebo",[9,23],null,{"type":28,"name":29,"description":39,"armGroupLabels":40,"otherNames":41},"Intravenous (IV)",[23],[33],{"type":28,"name":35,"description":39,"armGroupLabels":43,"otherNames":37},[9,15,20],[45],{"name":46,"affiliation":5,"role":47},"ABBVIE INC.","STUDY_DIRECTOR",[49,62,71,80,90,99,108,117,127,138],{"facility":50,"status":37,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":37},"Franco Felizarta, Md \u002FId# 223931","Bakersfield","California","93301","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-119.01871,35.37329,{"lat":60,"lon":59},{"facility":63,"status":37,"city":64,"state":52,"zip":65,"country":54,"countryCode":55,"cosmosGeoPoint":66,"geoPoint":70,"contacts":37},"Ruane Clinical Research Group \u002FID# 224496","Los Angeles","90036",{"type":57,"coordinates":67},[68,69],-118.24368,34.05223,{"lat":69,"lon":68},{"facility":72,"status":37,"city":73,"state":52,"zip":74,"country":54,"countryCode":55,"cosmosGeoPoint":75,"geoPoint":79,"contacts":37},"Quest Clinical Research \u002FID# 223925","San Francisco","94115-3037",{"type":57,"coordinates":76},[77,78],-122.41942,37.77493,{"lat":78,"lon":77},{"facility":81,"status":37,"city":82,"state":83,"zip":84,"country":54,"countryCode":55,"cosmosGeoPoint":85,"geoPoint":89,"contacts":37},"Central Texas Clinical Research \u002FID# 223937","Austin","Texas","78705-3326",{"type":57,"coordinates":86},[87,88],-97.74306,30.26715,{"lat":88,"lon":87},{"facility":91,"status":37,"city":92,"state":83,"zip":93,"country":54,"countryCode":55,"cosmosGeoPoint":94,"geoPoint":98,"contacts":37},"St. Hope Foundation, Inc. \u002FID# 224492","Bellaire","77401-4528",{"type":57,"coordinates":95},[96,97],-95.45883,29.70579,{"lat":97,"lon":96},{"facility":100,"status":37,"city":101,"state":83,"zip":102,"country":54,"countryCode":55,"cosmosGeoPoint":103,"geoPoint":107,"contacts":37},"North TX Infectious Diseases \u002FID# 224494","Dallas","75246",{"type":57,"coordinates":104},[105,106],-96.80667,32.78306,{"lat":106,"lon":105},{"facility":109,"status":37,"city":110,"state":83,"zip":111,"country":54,"countryCode":55,"cosmosGeoPoint":112,"geoPoint":116,"contacts":37},"The Crofoot Research Center, Inc \u002FID# 224493","Houston","77098-3900",{"type":57,"coordinates":113},[114,115],-95.36327,29.76328,{"lat":115,"lon":114},{"facility":118,"status":37,"city":119,"state":120,"zip":121,"country":54,"countryCode":55,"cosmosGeoPoint":122,"geoPoint":126,"contacts":37},"Peter Shalit, M.D. \u002FID# 224801","Seattle","Washington","98104-3595",{"type":57,"coordinates":123},[124,125],-122.33207,47.60621,{"lat":125,"lon":124},{"facility":128,"status":37,"city":129,"state":37,"zip":130,"country":131,"countryCode":132,"cosmosGeoPoint":133,"geoPoint":137,"contacts":37},"Ponce Medical School Foundation \u002FID# 224230","Ponce","00716-0377","Puerto Rico","PR",{"type":57,"coordinates":134},[135,136],-66.62398,18.01031,{"lat":136,"lon":135},{"facility":139,"status":37,"city":140,"state":37,"zip":141,"country":131,"countryCode":132,"cosmosGeoPoint":142,"geoPoint":146,"contacts":37},"Puerto Rico AIDS Clinical Trials Unit CRS \u002FID# 223936","San Juan","00935",{"type":57,"coordinates":143},[144,145],-66.10572,18.46633,{"lat":145,"lon":144},{"type":148,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100423859","phase-1-study-to-evaluate-the-safety-and-how-the-body-handles-a-single-dose-of-subcutaneous-sc-and-intravenous-iv-budigalimab-in-adult-participants-living-with-human-immunodeficiency-virus-hiv-100423859",false,"NCT04799353","Study to Evaluate the Safety and How the Body Handles a Single Dose of Subcutaneous (SC) and Intravenous (IV) Budigalimab in Adult Participants Living With Human Immunodeficiency Virus (HIV)","A Randomized, Double-Blind, Placebo-controlled Single-Dose Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous and Intravenous Administration of Budigalimab in Adult People Living With HIV-1 (PLWH)","Inclusion Criteria:\n\n* Condition of generally good health, body mass index ≥ 18.0 to \\\u003C 35.0 kg\u002Fm2.\n* Laboratory values must meet acceptable criteria.\n* Human Immunodeficiency Virus (HIV-1) infected on antiretroviral therapy (ART) for at least 12 months prior to screening and on current ART regimen for at least 8 weeks prior to screening.\n* CD4 cell count ≥ 450 cells\u002FμL at Screening and during the 12 months prior to Screening.\n* Plasma HIV-1 RNA below the lower limit of quantification at Screening and at least 6 months prior to Screening.\n* Participants agreeing to use an effective barrier method of protection (male and\u002For female condom) during sexual activity from Study Day 1 through last study visit for the purposes of prevention of HIV transmission.\n\nExclusion Criteria:\n\n* Participants with signs\u002Fsymptoms associated with SARS-CoV-2 infection OR Current SARS-CoV-2 infection by any viral nucleic acid test completed within 7 days prior to the Day 1 dose.\n* Participants having history or ongoing diagnosis of acquired immunodeficiency syndrome (AIDS)-defining illness.\n* Participants having history of or active immunodeficiency (other than HIV).\n* Participants having active autoimmune disease or history of autoimmune disease that has required systemic treatment.\n* Prior therapy\u002Fexposure to budigalimab or any other immune checkpoint inhibitor \\[e.g., anti-programmed cell death protein 1(PD-1), anti-PD-L1, anti-PD-L2, anti-CTLA4\\].\n* Participants having clinically significant medical disorders that might expose the subjects to undue risk of harm, confound study outcomes, or prevent the subject from completing the study.\n* Participants having active or suspected malignancy or history of malignancy (other than basal cell skin cancer or cervical carcinoma in situ) in the past 5 years.\n* Participants with history of or active tuberculosis (TB) at screening.\n* Participants having known psychiatric or substance abuse disorders that would interfere with adherence to study requirements.\n* Participants who have received immunomodulatory or immunosuppressive (including IV\u002Forally administered \\[PO\\] steroids at any dose, but excluding steroids that are inhaled, topical or via local injection) therapy within 24 weeks prior to the first dose of study drug.","ALL","18 Years","65 Years",{"count":160,"type":161},33,"ACTUAL","INTERVENTIONAL",[164],"PHASE1","This study will evaluate how safe Budigalimab is and how it moves within the body in adult participants with HIV-1 infection.\n\nBudigalimab is an investigational drug being evaluated for the treatment of Human Immunodeficiency Virus. Study participants will be assigned to one of the 4 treatment groups and will receive a single dose of Budigalimab or placebo subcutaneous (SC) and intravenous (IV). Around 32 participants 18-65 years of age living with Human Immunodeficiency Virus will be enrolled in the study in approximately 9 sites worldwide.\n\nEach participant will receive single dose of SC and IV Budigalimab and\u002For Placebo on day 1 and will be followed for 24 weeks.\n\nParticipants will attend weekly to every two and every four weeks visits during the study at a hospital. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects. There may be higher treatment burden for participants in this trial.",[167],"Human Immunodeficiency Virus (HIV)",[167,29,33],"COMPLETED","2022-10-14",{"date":172,"type":161},"2022-10-17",{"date":174,"type":161},"2021-03-15",{"date":176,"type":161},"2022-10-11",{"name":5,"class":6},10]