[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555869":3},{"organization":4,"outcomesModule":7,"designInfo":105,"detailedDescription":111,"studyPopulation":11,"armGroups":112,"interventions":132,"overallOfficials":141,"centralContacts":146,"locations":152,"responsibleParty":325,"collaborators":327,"id":332,"slug":333,"hasResults":334,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":11,"eligibilityCriteria":338,"healthyVolunteers":339,"sex":340,"minAge":11,"maxAge":341,"enrollmentInfo":342,"targetDuration":11,"studyType":345,"phases":346,"briefSummary":348,"conditions":349,"keywords":11,"overallStatus":169,"whyStopped":11,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":360},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"primaryOutcomes":8,"secondaryOutcomes":43,"otherOutcomes":11},[9,13,15,18,20,23,25,27,30,33,35,37,39,41],{"measure":10,"description":11,"timeFrame":12},"Proportion of infants with at least one Grade 3 or higher Adverse Event (AE) (one dose)",null,"Day 0 through Week 12",{"measure":14,"description":11,"timeFrame":12},"Proportion of infants with at least one Grade 3 or higher AE assessed as related to study product (one dose)",{"measure":16,"description":11,"timeFrame":17},"Proportion of infants with at least one Grade 3 or higher AE (two doses)","Day 0 through Week 24",{"measure":19,"description":11,"timeFrame":17},"Proportion of infants with at least one Grade 3 or higher AE assessed as related to study product (two doses)",{"measure":21,"description":11,"timeFrame":22},"PGT121.414.LS maximum concentration (Cmax) (single\u002Ffirst dose)","Day 0 through Week 48",{"measure":24,"description":11,"timeFrame":22},"PGT121.414.LS time of maximum concentration (Tmax) (single\u002Ffirst dose)",{"measure":26,"description":11,"timeFrame":12},"PGT121.414.LS area under the curve (AUC(0-12WK)) (single\u002Ffirst dose)",{"measure":28,"description":11,"timeFrame":29},"PGT121.414.LS concentration at the end of the first dose interval (C(12WK)) (single\u002Ffirst dose)","Week 12",{"measure":31,"description":11,"timeFrame":32},"PGT121.414.LS concentration at the end of the second dose interval (C(24WK)) (two doses)","Week 24",{"measure":34,"description":11,"timeFrame":22},"VRC07-523LS maximum concentration (Cmax) (single\u002Ffirst dose)",{"measure":36,"description":11,"timeFrame":22},"VRC07-523LS time of maximum concentration (Tmax) (single\u002Ffirst dose)",{"measure":38,"description":11,"timeFrame":12},"VRC07-523LS area under the curve (AUC(0-12WK))",{"measure":40,"description":11,"timeFrame":29},"VRC07-523LS concentration at the end of the first dose interval (C(12WK)) single\u002Ffirst dose)",{"measure":42,"description":11,"timeFrame":32},"VRC07-523LS concentration at the end of the second dose interval (C(24WK)) (two doses)",[44,47,49,51,53,55,57,59,62,64,67,70,72,74,76,78,80,82,84,86,88,90,92,94,96,98,99,100,102],{"measure":45,"description":11,"timeFrame":46},"Proportion of infants with at least one Grade 3 or higher AE","Day 0 through Week 96",{"measure":48,"description":11,"timeFrame":46},"Proportion of infants with at least one Grade 3 or higher AE assessed as related to study product",{"measure":50,"description":11,"timeFrame":12},"Proportion of infants with at least one Grade 2 or higher AE (one dose)",{"measure":52,"description":11,"timeFrame":12},"Proportion of infants with at least one Grade 2 or higher AE assessed as related to study product (one dose)",{"measure":54,"description":11,"timeFrame":17},"Proportion of infants with at least one Grade 2 or higher AE (two doses)",{"measure":56,"description":11,"timeFrame":17},"Proportion of infants with at least one Grade 2 or higher AE assessed as related to study product (two doses)",{"measure":58,"description":11,"timeFrame":12},"Proportion of infants with any AEs that lead to study product discontinuation",{"measure":60,"description":11,"timeFrame":61},"PGT121.414.LS AUC(0-48WK) after single dose administration","Week 48",{"measure":63,"description":11,"timeFrame":61},"PGT121.414.LS concentration after single dose administration",{"measure":65,"description":11,"timeFrame":66},"PGT121.414.LS concentration after two dose administration","Week 60",{"measure":68,"description":11,"timeFrame":69},"PGT121.414.LS apparent clearance (CL\u002FF)","Day 0 through Week 60",{"measure":71,"description":11,"timeFrame":22},"PGT121.414.LS half-life (T1\u002F2) following single dose administration",{"measure":73,"description":11,"timeFrame":69},"PGT121.414.LS half-life (T1\u002F2) following two dose administration",{"measure":75,"description":11,"timeFrame":61},"VRC07-523LS AUC(0-48WK) after single dose administration",{"measure":77,"description":11,"timeFrame":61},"VRC07-523LS concentration after single dose administration",{"measure":79,"description":11,"timeFrame":66},"VRC07-523LS concentration after two dose administration",{"measure":81,"description":11,"timeFrame":69},"VRC07-523LS apparent clearance (CL\u002FF)",{"measure":83,"description":11,"timeFrame":22},"VRC07-523LS half-life (T1\u002F2) following single dose administration",{"measure":85,"description":11,"timeFrame":69},"VRC07-523LS half-life (T1\u002F2) following tow dose administration",{"measure":87,"description":11,"timeFrame":29},"Proportion of infants with PGT121.414.LS concentrations > 20 and > 50 mcg\u002FmL following single\u002Ffirst dose administration",{"measure":89,"description":11,"timeFrame":32},"Proportion of infants with PGT121.414.LS concentrations > 20 and > 50 mcg\u002FmL following two dose administration",{"measure":91,"description":11,"timeFrame":29},"Proportion of infants with VRC07-523LS concentrations > 10 and > 20 mcg\u002FmL following single\u002Ffirst dose administration",{"measure":93,"description":11,"timeFrame":32},"Proportion of infants with PGT121.414.LS concentrations > 10 and > 20 mcg\u002FmL following two dose administration",{"measure":95,"description":11,"timeFrame":32},"Proportion of infants with anti-PGT121.414.LS antibodies detected",{"measure":97,"description":11,"timeFrame":32},"Proportion of infants with anti-VRC07-523LS antibodies detected",{"measure":95,"description":11,"timeFrame":61},{"measure":97,"description":11,"timeFrame":61},{"measure":101,"description":11,"timeFrame":46},"Proportion of infants with confirmed HIV infection following receipt of study product",{"measure":103,"description":11,"timeFrame":104},"Frequency of study product injection site local reactions for one and two SC doses of PGT121.414.LS alone or in combination with VRC07-523LS","Day 0 through Week 13",{"allocation":106,"interventionModel":107,"interventionModelDescription":11,"primaryPurpose":108,"observationalModel":11,"timePerspective":11,"maskingInfo":109},"NON_RANDOMIZED","SEQUENTIAL","PREVENTION",{"masking":110,"maskingDescription":11,"whoMasked":11},"NONE","This is an open-label, phase I study of the potent, broadly neutralizing anti-HIV monoclonal antibodies (mAb) PGT121.414.LS alone and in combination with VRC07-523LS administered soon after birth in infants exposed to HIV-1. The study is designed to assess the safety and pharmacokinetics (PK) profile of one and two subcutaneous (SC) doses of PGT121.414.LS alone or in combination with VRC07-523LS through Week 12 and Week 24, respectively.",[113,119,123,128],{"label":114,"type":115,"description":116,"interventionNames":117},"Cohort 1 Stratum Formula Fed (FF)","EXPERIMENTAL","Single subcutaneous (SC) dose of PGT121.414.LS at birth, based on weight.",[118],"Drug: PGT121.414.LS",{"label":120,"type":115,"description":121,"interventionNames":122},"Cohort 1 Stratum Breastfed (BF)","Initial SC dose of PGT121.414.LS at birth, based on weight. Second SC dose of 100 mg PGT121.414.LS at Week 12, if still breastfeeding. Dosing at Week 12 is not based on weight.",[118],{"label":124,"type":115,"description":125,"interventionNames":126},"Cohort 2 Stratum FF","Single SC doses of PGT121.414.LS and VRC07-523LS at birth, based on weight.",[118,127],"Drug: VRC07-523LS",{"label":129,"type":115,"description":130,"interventionNames":131},"Cohort 2 Stratum BF","Initial SC doses of PGT121.414.LS and VRC07-523LS at birth, based on weight. Second SC doses of 100 mg of PGT121.414.LS and 100 mg VRC07-523LS at Week 12, if still breastfeeding. Dosing at Week 12 is not based on weight.",[118,127],[133,138],{"type":134,"name":135,"description":136,"armGroupLabels":137,"otherNames":11},"DRUG","PGT121.414.LS","Administered SC in the thigh",[120,114,129,124],{"type":134,"name":139,"description":136,"armGroupLabels":140,"otherNames":11},"VRC07-523LS",[129,124],[142],{"name":143,"affiliation":144,"role":145},"Coleen Cunningham","University of California, Irvine","STUDY_CHAIR",[147],{"name":148,"role":149,"phone":150,"phoneExt":11,"email":151},"Emily Brown","CONTACT","919-321-3806","embrown@fhi360.org",[153,167,178,188,198,208,218,228,238,244,254,264,275,281,292,303,315],{"facility":154,"status":155,"city":156,"state":157,"zip":158,"country":159,"countryCode":160,"cosmosGeoPoint":161,"geoPoint":166,"contacts":11},"Site 5112, David Geffen School of Medicine at UCLA","NOT_YET_RECRUITING","Los Angeles","California","90095","United States","US",{"type":162,"coordinates":163},"Point",[164,165],-118.24368,34.05223,{"lat":165,"lon":164},{"facility":168,"status":169,"city":170,"state":171,"zip":172,"country":159,"countryCode":160,"cosmosGeoPoint":173,"geoPoint":177,"contacts":11},"Site 5052, University of Colorado Denver","RECRUITING","Aurora","Colorado","80045",{"type":162,"coordinates":174},[175,176],-104.83192,39.72943,{"lat":176,"lon":175},{"facility":179,"status":169,"city":180,"state":181,"zip":182,"country":159,"countryCode":160,"cosmosGeoPoint":183,"geoPoint":187,"contacts":11},"Site 5051, University of Florida Jacksonville","Jacksonville","Florida","32209",{"type":162,"coordinates":184},[185,186],-81.65565,30.33218,{"lat":186,"lon":185},{"facility":189,"status":190,"city":191,"state":181,"zip":192,"country":159,"countryCode":160,"cosmosGeoPoint":193,"geoPoint":197,"contacts":11},"Site 5127, Pediatric Perinatal HIV","WITHDRAWN","Miami","33136",{"type":162,"coordinates":194},[195,196],-80.19366,25.77427,{"lat":196,"lon":195},{"facility":199,"status":155,"city":200,"state":201,"zip":202,"country":159,"countryCode":160,"cosmosGeoPoint":203,"geoPoint":207,"contacts":11},"Site 5030, Emory University School of Medicine","Atlanta","Georgia","30322",{"type":162,"coordinates":204},[205,206],-84.38798,33.749,{"lat":206,"lon":205},{"facility":209,"status":190,"city":210,"state":211,"zip":212,"country":159,"countryCode":160,"cosmosGeoPoint":213,"geoPoint":217,"contacts":11},"Site 5083, Rush University Cook County Hospital Chicago","Chicago","Illinois","60612",{"type":162,"coordinates":214},[215,216],-87.65005,41.85003,{"lat":216,"lon":215},{"facility":219,"status":169,"city":220,"state":221,"zip":222,"country":159,"countryCode":160,"cosmosGeoPoint":223,"geoPoint":227,"contacts":11},"Site 5092, Johns Hopkins University Baltimore","Baltimore","Maryland","21287",{"type":162,"coordinates":224},[225,226],-76.61219,39.29038,{"lat":226,"lon":225},{"facility":229,"status":169,"city":230,"state":231,"zip":232,"country":159,"countryCode":160,"cosmosGeoPoint":233,"geoPoint":237,"contacts":11},"Site 5114, Bronx-Lebanon Hospital Center","The Bronx","New York","10457",{"type":162,"coordinates":234},[235,236],-73.86641,40.84985,{"lat":236,"lon":235},{"facility":239,"status":155,"city":230,"state":231,"zip":240,"country":159,"countryCode":160,"cosmosGeoPoint":241,"geoPoint":243,"contacts":11},"Site 5013, Jacobi Medical Center Bronx","10461",{"type":162,"coordinates":242},[235,236],{"lat":236,"lon":235},{"facility":245,"status":155,"city":246,"state":247,"zip":248,"country":159,"countryCode":160,"cosmosGeoPoint":249,"geoPoint":253,"contacts":11},"Site 6501, St. Jude Children's Research Hospital","Memphis","Tennessee","38105",{"type":162,"coordinates":250},[251,252],-90.04898,35.14953,{"lat":252,"lon":251},{"facility":255,"status":169,"city":256,"state":257,"zip":258,"country":159,"countryCode":160,"cosmosGeoPoint":259,"geoPoint":263,"contacts":11},"Site 5128, Baylor College of Medicine\u002FTexas Children's Hospital","Houston","Texas","77030",{"type":162,"coordinates":260},[261,262],-95.36327,29.76328,{"lat":262,"lon":261},{"facility":265,"status":190,"city":266,"state":267,"zip":268,"country":267,"countryCode":269,"cosmosGeoPoint":270,"geoPoint":274,"contacts":11},"Site 5072, Hospital Federal dos Servidores do Estado","Rio de Janeiro","Brazil","CEP 20221-903","BR",{"type":162,"coordinates":271},[272,273],-43.18223,-22.90642,{"lat":273,"lon":272},{"facility":276,"status":155,"city":266,"state":11,"zip":277,"country":267,"countryCode":269,"cosmosGeoPoint":278,"geoPoint":280,"contacts":11},"Site 5097, Hospital Geral De Nova Iguacu Brazil","CEP 26030-380",{"type":162,"coordinates":279},[272,273],{"lat":273,"lon":272},{"facility":282,"status":155,"city":283,"state":11,"zip":284,"country":285,"countryCode":286,"cosmosGeoPoint":287,"geoPoint":291,"contacts":11},"Site 5121, Kenya Medical Research Institute\u002FWalter Reed Project Clinical Research Center, Kericho","Kericho","20200","Kenya","KE",{"type":162,"coordinates":288},[289,290],35.28314,-0.36774,{"lat":290,"lon":289},{"facility":293,"status":155,"city":294,"state":295,"zip":296,"country":295,"countryCode":297,"cosmosGeoPoint":298,"geoPoint":302,"contacts":11},"Site 32513, IMPAACT\u002FGamma Project\u002FUPR Pediatric HIV\u002FAIDS Research Network CRS","San Juan","Puerto Rico","00935","PR",{"type":162,"coordinates":299},[300,301],-66.10572,18.46633,{"lat":301,"lon":300},{"facility":304,"status":155,"city":305,"state":306,"zip":307,"country":308,"countryCode":309,"cosmosGeoPoint":310,"geoPoint":314,"contacts":11},"Site 8950, FAMCRU","Cape Town","Parrow Valley","7505","South Africa","ZA",{"type":162,"coordinates":311},[312,313],18.42322,-33.92584,{"lat":313,"lon":312},{"facility":316,"status":155,"city":317,"state":11,"zip":11,"country":318,"countryCode":319,"cosmosGeoPoint":320,"geoPoint":324,"contacts":11},"Site 31890, Harare Family Care","Harare","Zimbabwe","ZW",{"type":162,"coordinates":321},[322,323],31.05337,-17.82772,{"lat":323,"lon":322},{"type":326,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[328,330],{"name":329,"class":6},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)",{"name":331,"class":6},"National Institute of Mental Health (NIMH)","100555869","phase-1-safety-and-pharmacokinetics-study-of-pgt121414ls-alone-and-in-combination-with-vrc07-523ls-in-infants-exposed-to-hiv-1-100555869",false,"NCT06517693","Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1","Open-Label, Phase I Study of the Safety and Pharmacokinetics of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1","Inclusion Criteria:\n\n* Birthing parent is of legal age or circumstance to provide independent informed consent and is willing and able to provide written informed consent for themselves and permission for their infant's participation in this study.\n* Birthing parent has confirmed HIV-1 infection based on positive test results from two samples collected from two separate blood collection tubes.\n* Infant was singleton or twin.\n* Infant's gestational age at birth was at least 36 weeks.\n* At birth, infant's weight was at least 2 kg.\n* At entry, infant is less than 72 hours of age and is anticipated to receive study product within 72 hours after birth.\n* At screening, infant has the following laboratory test results:\n\n  * Hemoglobin, normal or grade 1 (≥13 g\u002FdL or ≥8.05 mmol\u002FL)\n  * Platelets, normal or grade 1 (≥100,000 cells\u002Fmm3 or ≥100.000 x10\\^9 cells\u002FL)\n  * Absolute neutrophil count (ANC), normal or grade 1\n\n    1. ≤24 hours old (≥4,000 cells\u002Fmm3 or ≥4.000 x10\\^9 cells\u002FL)\n    2. \\>24 hours old (≥1,250 cells\u002Fmm3 or ≥1.250 x10\\^9 cells\u002FL)\n  * Alanine transaminase (ALT), normal (\\\u003C1.25 x ULN)\n* At entry, infant is generally healthy as determined by the site investigator based on review of all available medical history information and physical examination findings.\n* Cohorts 1 and 2, Strata BF only: At entry, infant is breastfeeding or the birthing parent has indicated an intention to initiate breastfeeding.\n* Cohorts 1 and 2, Strata FF, only: At entry, infant is not breastfeeding and the birthing parent has indicated no intention to breastfeed.\n* At entry, infant is at increased risk of HIV acquisition.\n\nCohorts 1 and 2, Strata FF only:\n\n* Birthing parent had acute HIV during this pregnancy; or\n* Birthing parent with detectable viral replication (plasma HIV RNA results at least 50 copies\u002FmL) during pregnancy who did not have confirmed viral suppression, defined as at least two consecutive plasma HIV RNA results less than 50 copies\u002FmL from specimens obtained at least four weeks apart with the latest result within four weeks prior to delivery; or\n* Birthing parent not receiving appropriate ART for at least two weeks, with any part of the two-week period occurring within four weeks prior to delivery, based on birthing parent's report or available medical records.\n\nCohorts 1 and 2, BF only:\n\n* Per birthing parent's report, intends to breastfeed\n\nExclusion Criteria:\n\n* Birthing parent has received any investigational product during this pregnancy.\n* Infant has received any active or passive HIV immunotherapy or any investigational product.\n* At entry, infant with a documented positive HIV Nucleic Acid Test (NAT) result.\n* Birthing parent or infant has any condition that, in the opinion of the site investigator or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.",true,"ALL","72 Hours",{"count":343,"type":344},48,"ESTIMATED","INTERVENTIONAL",[347],"PHASE1","The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of the potent, broadly neutralizing anti-HIV monoclonal antibodies (mAb) PGT121.414.LS alone and in combination with VRC07-523LS soon after birth in infants exposed to HIV-1.",[350],"HIV-1","2026-08-24",{"date":353,"type":354},"2026-08-25","ACTUAL",{"date":356,"type":354},"2026-01-05",{"date":358,"type":344},"2028-06-30",{"name":5,"class":6},17]