[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530851":3},{"organization":4,"armGroups":7,"interventions":43,"overallOfficials":105,"centralContacts":115,"locations":123,"responsibleParty":537,"collaborators":539,"id":543,"slug":544,"hasResults":545,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":549,"eligibilityCriteria":550,"healthyVolunteers":545,"sex":551,"minAge":552,"maxAge":91,"enrollmentInfo":553,"targetDuration":91,"studyType":556,"phases":557,"briefSummary":559,"conditions":560,"keywords":91,"overallStatus":126,"whyStopped":91,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":571},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",[8,17,25,30,34,39],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Standard of Care (SOC)","ACTIVE_COMPARATOR","* Weeks 1-8: INH 300 mg, RIF 600 mg, PZA weight-based, EMB weight-based\n* Weeks 9-26: INH 300 mg, RIF 600 mg (or weight-based dosing following WHO guidance)",[13,14,15,16],"Drug: Isoniazid","Drug: Rifampicin","Drug: Pyrazinamide","Drug: Ethambutol",{"label":18,"type":19,"description":20,"interventionNames":21},"Arm 2: Bedaquiline (BDQ), Pretomanid (Pa), and Linezolid (LZD)","EXPERIMENTAL","* Weeks 1-8: BDQ 400 mg for 2 weeks and then 200 mg for 6 weeks, Pa 200 mg, LZD 600 mg\n* Weeks 9-26: INH 300 mg, RIF 600 mg (or weight-based dosing following WHO guidance)",[13,14,22,23,24],"Drug: Bedaquiline","Drug: Pretomanid","Drug: Linezolid",{"label":26,"type":19,"description":27,"interventionNames":28},"Arm 3A: BDQ, Pa and TBI-223 (1200 mg)","* Weeks 1-8: BDQ 400 mg for 2 weeks and then 200 mg for 6 weeks, Pa 200 mg, TBI-223 1200 mg\n* Weeks 9-26: INH 300 mg, RIF 600 mg (or weight-based dosing following WHO guidance)",[13,14,22,23,29],"Drug: TBI-223",{"label":31,"type":19,"description":32,"interventionNames":33},"Arm 3B: BDQ, Pa and TBI-223 (2400 mg)","* Weeks 1-8: BDQ 400 mg for 2 weeks and then 200 mg for 6 weeks, Pa 200 mg, TBI-223 2400 mg\n* Weeks 9-26: INH 300 mg, RIF 600 mg (or weight-based dosing following WHO guidance)",[13,14,22,23,29],{"label":35,"type":19,"description":36,"interventionNames":37},"Arm 4A: BDQ, Pa and Sutezolid (SZD) (800 mg)","* Weeks 1-8: BDQ 400 mg for 2 weeks and then 200 mg for 6 weeks, Pa 200 mg, SZD 800 mg\n* Weeks 9-26: INH 300 mg, RIF 600 mg (or weight-based dosing following WHO guidance)",[13,14,22,23,38],"Drug: Sutezolid",{"label":40,"type":19,"description":41,"interventionNames":42},"Arm 4B: BDQ, Pa and SZD (1600 mg)","* Weeks 1-8: BDQ 400 mg for 2 weeks and then 200 mg for 6 weeks, Pa 200 mg, SZD 1600 mg\n* Weeks 9-26: INH 300 mg, RIF 600 mg (or weight-based dosing following WHO guidance)",[13,14,22,23,38],[44,51,57,63,69,75,81,87,92,98,101],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"DRUG","Isoniazid","INH 300 mg will be administered as one tablet orally once daily.",[9,18,26,31,35,40],[50],"INH",{"type":45,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"Rifampicin","RIF 600 mg will be administered as two 300 mg capsules orally once daily on an empty stomach, 1 hour before or 2 hours after eating a meal.",[9,18,26,31,35,40],[56],"RIF",{"type":45,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"Pyrazinamide","PZA will be administered as 500 mg tablets, based on weight, orally once daily.",[9],[62],"PZA",{"type":45,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"Ethambutol","EMB will be administered as 400 mg tablets, based on weight, orally once daily.",[9],[68],"EMB",{"type":45,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"Bedaquiline","BDQ 400 mg will be administered as four 100 mg tablets orally once daily with a meal for the first 2 weeks followed by 200 mg (two 100 mg tablets) orally once daily with a meal for 6 weeks.",[18,26,31,35,40],[74],"BDQ",{"type":45,"name":76,"description":77,"armGroupLabels":78,"otherNames":79},"Pretomanid","Pa 200 mg will be administered as one 200 mg tablet orally once daily with a meal.",[18,26,31,35,40],[80],"Pa",{"type":45,"name":82,"description":83,"armGroupLabels":84,"otherNames":85},"Linezolid","LZD 600 mg will be administered as one 600 mg tablet orally once daily.",[18],[86],"LZD",{"type":45,"name":88,"description":89,"armGroupLabels":90,"otherNames":91},"TBI-223","TBI-223 2400 mg once daily will be administered as four 600 mg tablets orally once daily with a meal.",[31],null,{"type":45,"name":93,"description":94,"armGroupLabels":95,"otherNames":96},"Sutezolid","SZD 1600 mg once daily will be administered as four 400 mg tablets orally once daily with a meal.",[40],[97],"SZD",{"type":45,"name":88,"description":99,"armGroupLabels":100,"otherNames":91},"TBI-223 1200 mg once daily will be administered as two 600 mg tablets orally with a meal.",[26],{"type":45,"name":93,"description":102,"armGroupLabels":103,"otherNames":104},"SZD 800 mg once daily will be administered as two 400 mg tablets orally once daily with a meal.",[35],[97],[106,110,113],{"name":107,"affiliation":108,"role":109},"Radojka Savic, PharmD, PhD","University of California","STUDY_CHAIR",{"name":111,"affiliation":112,"role":109},"Kelly Dooley, MD, PhD","Vanderbilt University Medical Center",{"name":114,"affiliation":108,"role":109},"Gustavo Velásquez, MD, MPH",[116,120],{"name":107,"role":117,"phone":118,"phoneExt":91,"email":119},"CONTACT","415-502-0640","rada.savic@ucsf.edu",{"name":111,"role":117,"phone":121,"phoneExt":91,"email":122},"615-322-8972","kelly.e.dooley@vumc.org",[124,142,158,172,189,199,215,231,245,261,275,291,307,318,328,344,360,371,385,396,410,421,434,450,464,478,494,505,521],{"facility":125,"status":126,"city":127,"state":91,"zip":128,"country":129,"countryCode":130,"cosmosGeoPoint":131,"geoPoint":136,"contacts":137},"12701, Gaborone CRS","RECRUITING","Gaborone","0000","Botswana","BW",{"type":132,"coordinates":133},"Point",[134,135],25.90859,-24.65451,{"lat":135,"lon":134},[138],{"name":139,"role":117,"phone":140,"phoneExt":91,"email":141},"Unoda Chakalisa","267-393-1353","uchakalisa@bhp.org.bw",{"facility":143,"status":126,"city":144,"state":91,"zip":145,"country":146,"countryCode":147,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"12201, Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS","Porto Alegre","91350","Brazil","BR",{"type":132,"coordinates":149},[150,151],-51.23019,-30.03283,{"lat":151,"lon":150},[154],{"name":155,"role":117,"phone":156,"phoneExt":91,"email":157},"Rita Lira","+55 51-33572603","lrita@ghc.com.br",{"facility":159,"status":126,"city":160,"state":91,"zip":161,"country":146,"countryCode":147,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"12101, Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS","Rio de Janeiro","21040",{"type":132,"coordinates":163},[164,165],-43.18223,-22.90642,{"lat":165,"lon":164},[168],{"name":169,"role":117,"phone":170,"phoneExt":91,"email":171},"Brenda Hoagland","55 21 38659122","brenda.hoagland@ipec.fiocruz.br",{"facility":173,"status":174,"city":175,"state":91,"zip":176,"country":177,"countryCode":178,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"30022, Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS","NOT_YET_RECRUITING","Port-au-Prince","6110","Haiti","HT",{"type":132,"coordinates":180},[181,182],-72.33881,18.54349,{"lat":182,"lon":181},[185],{"name":186,"role":117,"phone":187,"phoneExt":91,"email":188},"Samuel Pierre","509-37407711","spierre@gheskio.org",{"facility":190,"status":174,"city":175,"state":91,"zip":176,"country":177,"countryCode":178,"cosmosGeoPoint":191,"geoPoint":193,"contacts":194},"31730, GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS",{"type":132,"coordinates":192},[181,182],{"lat":182,"lon":181},[195],{"name":196,"role":117,"phone":197,"phoneExt":91,"email":198},"Yvetot Joseph","509 29401431","yvetotjoseph@gheskio.org",{"facility":200,"status":174,"city":201,"state":91,"zip":202,"country":203,"countryCode":204,"cosmosGeoPoint":205,"geoPoint":209,"contacts":210},"31441, Byramjee Jeejeebhoy Medical College (BJMC) CRS","Pune","411001","India","IN",{"type":132,"coordinates":206},[207,208],73.85535,18.51957,{"lat":208,"lon":207},[211],{"name":212,"role":117,"phone":213,"phoneExt":91,"email":214},"Nishi Suryavanshi","91-9823248979","nishisuryavanshi@hotmail.com",{"facility":216,"status":126,"city":217,"state":91,"zip":218,"country":219,"countryCode":220,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"12601, Moi University Clinical Research Center (MUCRC) CRS","Eldoret","30100","Kenya","KE",{"type":132,"coordinates":222},[223,224],35.26993,0.52036,{"lat":224,"lon":223},[227],{"name":228,"role":117,"phone":229,"phoneExt":91,"email":230},"Voila Kirui","254-711-729856","viola.kirui@gmail.com",{"facility":232,"status":126,"city":233,"state":91,"zip":234,"country":219,"countryCode":220,"cosmosGeoPoint":235,"geoPoint":239,"contacts":240},"12501, Kenya Medical Research Institute\u002FWalter Reed Project Clinical Research Center (KEMRI\u002FWRP) CRS","Kericho","20200",{"type":132,"coordinates":236},[237,238],35.28314,-0.36774,{"lat":238,"lon":237},[241],{"name":242,"role":117,"phone":243,"phoneExt":91,"email":244},"Samwel Chirchir","+254 52-20 36100","samwel.chirchir@usamru-k.org",{"facility":246,"status":174,"city":247,"state":91,"zip":248,"country":249,"countryCode":250,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"30301, Blantyre CRS","Blantyre","265","Malawi","MW",{"type":132,"coordinates":252},[253,254],35.00854,-15.78499,{"lat":254,"lon":253},[257],{"name":258,"role":117,"phone":259,"phoneExt":91,"email":260},"Dumisile Huwa","265-811885","dhuwa@jhp.mw",{"facility":262,"status":174,"city":263,"state":91,"zip":264,"country":249,"countryCode":250,"cosmosGeoPoint":265,"geoPoint":269,"contacts":270},"12001, Malawi CRS","Lilongwe","A-104",{"type":132,"coordinates":266},[267,268],33.78725,-13.96692,{"lat":268,"lon":267},[271],{"name":272,"role":117,"phone":273,"phoneExt":91,"email":274},"Thokozani Makuhunga","265-175-5056","tmakuhunga@unclilongwe.org",{"facility":276,"status":174,"city":277,"state":91,"zip":278,"country":279,"countryCode":280,"cosmosGeoPoint":281,"geoPoint":285,"contacts":286},"32078, Nutrición-Mexico CRS","Mexico City","14080","Mexico","MX",{"type":132,"coordinates":282},[283,284],-99.12766,19.42847,{"lat":284,"lon":283},[287],{"name":288,"role":117,"phone":289,"phoneExt":91,"email":290},"Brenda Crabtree","52-5550682274","brenda.crabtree@infecto.mx",{"facility":292,"status":174,"city":293,"state":91,"zip":294,"country":295,"countryCode":296,"cosmosGeoPoint":297,"geoPoint":301,"contacts":302},"11301, Barranco CRS","Lima","1010","Peru","PE",{"type":132,"coordinates":298},[299,300],-77.02824,-12.04318,{"lat":300,"lon":299},[303],{"name":304,"role":117,"phone":305,"phoneExt":91,"email":306},"Consuelo Tristan","+51 1-206-7800","ctristan@impactaperu.org",{"facility":308,"status":126,"city":293,"state":91,"zip":309,"country":295,"countryCode":296,"cosmosGeoPoint":310,"geoPoint":312,"contacts":313},"31985, Socios En Salud Sucursal Perú CRS","15046",{"type":132,"coordinates":311},[299,300],{"lat":300,"lon":299},[314],{"name":315,"role":117,"phone":316,"phoneExt":91,"email":317},"Bruno Martel Chavez","51-945230659","bmartel_ses@pih.org",{"facility":319,"status":174,"city":293,"state":91,"zip":91,"country":295,"countryCode":296,"cosmosGeoPoint":320,"geoPoint":322,"contacts":323},"11302, San Miguel CRS San Miguel",{"type":132,"coordinates":321},[299,300],{"lat":300,"lon":299},[324],{"name":325,"role":117,"phone":326,"phoneExt":91,"email":327},"Helen Chapa","+51-1-562-1600","hchapa@impactaperu.org",{"facility":329,"status":174,"city":330,"state":91,"zip":331,"country":332,"countryCode":333,"cosmosGeoPoint":334,"geoPoint":338,"contacts":339},"31981, TB HIV Innovations and Clinical Research Foundation Corp.","Cavite","4114","Philippines","PH",{"type":132,"coordinates":335},[336,337],120.76978,15.67785,{"lat":337,"lon":336},[340],{"name":341,"role":117,"phone":342,"phoneExt":91,"email":343},"Maria Gler","+63 917-823-0431","msgler@my.dlshsi.edu.ph",{"facility":345,"status":126,"city":346,"state":91,"zip":347,"country":348,"countryCode":349,"cosmosGeoPoint":350,"geoPoint":354,"contacts":355},"31793, South African Tuberculosis Vaccine Initiative (SATVI) CRS","Cape Town","6850","South Africa","ZA",{"type":132,"coordinates":351},[352,353],18.42322,-33.92584,{"lat":353,"lon":352},[356],{"name":357,"role":117,"phone":358,"phoneExt":91,"email":359},"Lynnett Stone","+27 23-346-5400","lynnett.stone@uct.ac.za",{"facility":361,"status":126,"city":346,"state":91,"zip":362,"country":348,"countryCode":349,"cosmosGeoPoint":363,"geoPoint":365,"contacts":366},"31792, University of Cape Town Lung Institute (UCTLI) CRS","7700",{"type":132,"coordinates":364},[352,353],{"lat":353,"lon":352},[367],{"name":368,"role":117,"phone":369,"phoneExt":91,"email":370},"Tammy Krige","+27 021-4066889","tammy.krige@uct.ac.za",{"facility":372,"status":126,"city":373,"state":91,"zip":374,"country":348,"countryCode":349,"cosmosGeoPoint":375,"geoPoint":379,"contacts":380},"31422, CAPRISA eThekwini CRS","Durban","40001",{"type":132,"coordinates":376},[377,378],31.0292,-29.8579,{"lat":378,"lon":377},[381],{"name":382,"role":117,"phone":383,"phoneExt":91,"email":384},"Bongekile Zuma","27-31-6550658","Bongi.zuma@caprisa.org",{"facility":386,"status":126,"city":373,"state":91,"zip":387,"country":348,"countryCode":349,"cosmosGeoPoint":388,"geoPoint":390,"contacts":391},"11201, Durban International CRS","4091",{"type":132,"coordinates":389},[377,378],{"lat":378,"lon":377},[392],{"name":393,"role":117,"phone":394,"phoneExt":91,"email":395},"Rosie Mngqibisa","27-31-2611093","mngqibisa@ecarefoundation.com",{"facility":397,"status":126,"city":398,"state":91,"zip":399,"country":348,"countryCode":349,"cosmosGeoPoint":400,"geoPoint":404,"contacts":405},"12301, Soweto ACTG CRS","Johannesburg","1864",{"type":132,"coordinates":401},[402,403],28.04363,-26.20227,{"lat":403,"lon":402},[406],{"name":407,"role":117,"phone":408,"phoneExt":91,"email":409},"Suri Moonsamy","+27-11-989-9905","moonsamys@phru.co.za",{"facility":411,"status":174,"city":398,"state":91,"zip":412,"country":348,"countryCode":349,"cosmosGeoPoint":413,"geoPoint":415,"contacts":416},"11101, University of the Witwatersrand Helen Joseph (WITS HJH) CRS","2193",{"type":132,"coordinates":414},[402,403],{"lat":403,"lon":402},[417],{"name":418,"role":117,"phone":419,"phoneExt":91,"email":420},"Betty Matome","+27 11-276-8800","bmatome@witshealth.co.za",{"facility":422,"status":126,"city":423,"state":91,"zip":91,"country":348,"countryCode":349,"cosmosGeoPoint":424,"geoPoint":428,"contacts":429},"31684, Rustenburg CRS","Rustenburg",{"type":132,"coordinates":425},[426,427],27.24208,-25.66756,{"lat":427,"lon":426},[430],{"name":431,"role":117,"phone":432,"phoneExt":91,"email":433},"Tiro Dinake","27-723-968-940","tdinake@auruminstitute.org",{"facility":435,"status":126,"city":436,"state":91,"zip":437,"country":438,"countryCode":439,"cosmosGeoPoint":440,"geoPoint":444,"contacts":445},"31784, Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS","Chiang Mai","50200","Thailand","TH",{"type":132,"coordinates":441},[442,443],98.98468,18.79038,{"lat":443,"lon":442},[446],{"name":447,"role":117,"phone":448,"phoneExt":91,"email":449},"Daralak Tavornprasit","66 5393 6148","daralak.t@cmu.ac.th",{"facility":451,"status":126,"city":452,"state":91,"zip":453,"country":438,"countryCode":439,"cosmosGeoPoint":454,"geoPoint":458,"contacts":459},"5116 Chiangrai Prachanukroh Hospital NICHD CRS","Chiang Rai","57000",{"type":132,"coordinates":455},[456,457],99.8325,19.90858,{"lat":457,"lon":456},[460],{"name":461,"role":117,"phone":462,"phoneExt":91,"email":463},"Pra-ornsuda Sukrakanchana","66-81-7468858","pra-ornsuda.sukrakanchana@phpt.org",{"facility":465,"status":126,"city":466,"state":91,"zip":467,"country":438,"countryCode":439,"cosmosGeoPoint":468,"geoPoint":472,"contacts":473},"31802, Thai Red Cross AIDS Research Centre (TRC-ARC) CRS","Pathum Wan","10330",{"type":132,"coordinates":469},[470,471],100.52329,13.73698,{"lat":471,"lon":470},[474],{"name":475,"role":117,"phone":476,"phoneExt":91,"email":477},"Parawee Thongpaeng","66-2-6523040","parawee.t@hivnat.org",{"facility":479,"status":126,"city":480,"state":91,"zip":481,"country":482,"countryCode":483,"cosmosGeoPoint":484,"geoPoint":488,"contacts":489},"12401, Joint Clinical Research Centre (JCRC)\u002FKampala CRS","Kampala","10005","Uganda","UG",{"type":132,"coordinates":485},[486,487],32.58219,0.31628,{"lat":487,"lon":486},[490],{"name":491,"role":117,"phone":492,"phoneExt":91,"email":493},"Sandra Rwambuya","256-417-723-000","dxr23@case.edu",{"facility":495,"status":174,"city":480,"state":91,"zip":496,"country":482,"countryCode":483,"cosmosGeoPoint":497,"geoPoint":499,"contacts":500},"30293 MU-JHU Research Collaboration (MUJHU CARE LTD) CRS","23491",{"type":132,"coordinates":498},[486,487],{"lat":487,"lon":486},[501],{"name":502,"role":117,"phone":503,"phoneExt":91,"email":504},"Deo Wabwire","256-414-541044","dwabwire@mujhu.org",{"facility":506,"status":126,"city":507,"state":91,"zip":508,"country":509,"countryCode":510,"cosmosGeoPoint":511,"geoPoint":515,"contacts":516},"32483 National Lung Hospital CRS","Hanoi","100000","Vietnam","VN",{"type":132,"coordinates":512},[513,514],105.84117,21.0245,{"lat":514,"lon":513},[517],{"name":518,"role":117,"phone":519,"phoneExt":91,"email":520},"Tran Viet Ha","84-912-785886","vietha@live.unc.edu",{"facility":522,"status":174,"city":523,"state":91,"zip":524,"country":525,"countryCode":526,"cosmosGeoPoint":527,"geoPoint":531,"contacts":532},"30313, Milton Park CRS","Harare","30313","Zimbabwe","ZW",{"type":132,"coordinates":528},[529,530],31.05337,-17.82772,{"lat":530,"lon":529},[533],{"name":534,"role":117,"phone":535,"phoneExt":91,"email":536},"Patience Sibanda","263-774-361-790","psibanda@uz-ctrc.org",{"type":538,"investigatorFullName":91,"investigatorTitle":91,"investigatorAffiliation":91,"oldNameTitle":91,"oldOrganization":91},"SPONSOR",[540],{"name":541,"class":542},"TB Alliance","UNKNOWN","100530851","phase-2-trial-of-novel-regimens-for-the-treatment-of-pulmonary-tuberculosis-100530851",false,"NCT06192160","Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis","A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis","RAD-TB","Inclusion Criteria:\n\n1. Pulmonary TB (among individuals either without history of prior TB treatment or with history of TB treatment completed more than 2 years prior to study entry), identified within 7 days prior to study entry by at least one sputum specimen positive for Mtb by Xpert. Semiquantitative Mtb results of \"medium\" or \"high\" from Xpert MTB\u002FRIF Ultra are required.\n2. Pulmonary TB with documented INH susceptibility (by Line Probe Assay (LPA) or Xpert MTB\u002FXDR or other validated molecular test) and with documented RIF susceptibility (by LPA or Xpert MTB\u002FRIF or Xpert MTB\u002FRIF Ultra or other validated molecular test) within 7 days prior to study entry.\n3. Documentation of HIV-1 infection status, as below:\n\n   Presence or absence of HIV-1 infection, as documented by:\n   * Any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E\u002FCIA) test kit, any time prior to study entry. AND for a positive result confirmation by one of the following:\n   * A second antibody test from different manufacturers or based on different principles and epitopes (combination antigen-antibody-based rapid tests may be used), or\n   * HIV-1 antigen, or\n   * Plasma HIV-1 RNA viral load, or\n   * A licensed Western blot\n4. For individuals with HIV: CD4+ cell count ≥100 cells\u002Fmm3 based on testing performed within 30 days prior to study entry.\n5. For individuals with HIV: Currently being treated with dolutegravir-based antiretroviral therapy (ART), or plan to initiate dolutegravir-based ART at or before study week 8.\n6. Individuals age ≥18 years.\n7. The following laboratory values obtained within 7 days prior to study entry at any network-approved non-U.S. laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs:\n\n   * Serum or plasma alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN)\n   * Serum or plasma total bilirubin ≤2 times ULN\n   * Serum or plasma creatinine ≤2 times ULN\n   * Serum or plasma potassium ≥3.5 mEq\u002FL\n   * Serum or plasma magnesium ≥1.0 mEq\u002FL (≥0.500 mmol\u002FL)\n   * Absolute neutrophil count (ANC) ≥1500\u002Fmm\\^3\n   * Hemoglobin ≥9.0 g\u002FdL\n   * Platelet count ≥100,000\u002Fmm\\^3\n   * Negative for, hepatitis B surface antigen (HBsAg)\n   * Negative for hepatitis C virus (HCV) antibody (or if HCV antibody positive, must have a negative HCV PCR)\n8. For female study candidates who are of reproductive potential, negative pregnancy test (urine HCG or serum β-HCG) within 3 days (72 hours) prior to entry by any network-approved non-U.S. laboratory or clinic that operates in accordance with GCLP and participates in appropriate external quality assurance programs.\n\n   Females who are of reproductive potential and who participate in sexual activity that could lead to pregnancy must agree to use at least two of the following forms of birth control while receiving TB study medications and for 12 months after stopping study medications:\n   * Male or female condoms\n   * Diaphragm or cervical cap (with spermicide, if available)\n   * Intrauterine device (IUD) or intrauterine system (IUS)\n   * Hormone-based birth control (e.g., oral contraceptives, Depo-Provera, NuvaRing, implants)\n\n   Female study candidates who are of reproductive potential, but who abstain from sexual activity that could lead to pregnancy require no additional contraception.\n\n   Female study candidates who are not of reproductive potential are eligible without requiring the use of contraceptives. Self-reported history is acceptable documentation of menopause (i.e., at least 1 year amenorrheic), hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; these candidates are all considered not of reproductive potential.\n9. For male study candidates who engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. They are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives while the individual is on study and for 90 days after experimental treatment discontinuation.\n\n   For male study candidates who have undergone successful vasectomy with documented azoospermia or have documented azoospermia for any other reason, are eligible without requiring the use of contraceptives.\n10. For male study candidates with pregnant partners, willingness to use condoms during vaginal intercourse while on study and for 90 days after experimental treatment discontinuation.\n11. For male study candidates, willingness to refrain from sperm donation while on study and for 90 days after experimental treatment discontinuation.\n12. Documentation of Karnofsky performance score ≥60 obtained within 14 days prior to study entry.\n13. Chest x-ray obtained within 14 days prior to study entry.\n14. A verifiable address or residence readily accessible for visiting, and willingness to inform the study team of any change of address during study treatment and follow-up period.\n15. Ability and willingness of individual to provide informed consent.\n\nExclusion Criteria:\n\n1. More than cumulative 7 days of treatment directed against active TB for the current TB episode in the 60 days preceding study entry.\n2. Current extrapulmonary TB, in the opinion of the investigator.\n3. QTcF interval \\>450 ms within 7 days prior to study entry.\n4. History of or ongoing heart failure.\n5. Personal or family history of congenital QT prolongation.\n6. History of known, untreated, ongoing hypothyroidism.\n7. History of or ongoing bradyarrhythmia.\n8. History of torsades de pointes.\n9. Current Grade 2 or higher peripheral neuropathy.\n10. Other medical conditions (e.g., diabetes, liver or kidney disease, blood disorders, chronic diarrhea), in the opinion of the site investigator, in which the current clinical condition of the participant is likely to prejudice the response to, or assessment of, treatment.\n11. Pregnant or breastfeeding or planning to become pregnant within the next 12 months.\n12. Weight \\\u003C35 kg.\n13. Unable to take oral medications.\n14. Taking any of prohibited medications.\n15. Known allergy\u002Fsensitivity or any hypersensitivity to components of investigational agents or their formulation.\n16. Active drug or alcohol use or dependence; or mental illness (e.g., major depression) that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n17. Taking an investigational drug or vaccine within 30 or more days prior to study entry.","ALL","18 Years",{"count":554,"type":555},315,"ESTIMATED","INTERVENTIONAL",[558],"PHASE2","A5409\u002FRAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB).\n\nA5409 hypothesizes that novel regimens for the treatment of pulmonary tuberculosis will result in superior early efficacy, as determined by longitudinal mycobacteria growth indicator tube (MGIT) liquid culture time to positivity (TTP) measurements over the first 6 weeks of treatment, and will have acceptable safety and tolerability over 8 weeks of treatment relative to standard of care \\[(SOC) isoniazid\u002Frifampicin\u002Fpyrazinamide\u002Fethambutol (HRZE)\\].\n\nThe study will run for 52 weeks, inclusive of 26 weeks of TB treatment comprised of 8 weeks of study treatment (experimental or SOC, based on treatment arm assignment) followed by 18 weeks of SOC continuation phase treatment with 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm.",[561],"Pulmonary Tuberculosis","2026-06-22",{"date":564,"type":565},"2026-06-23","ACTUAL",{"date":567,"type":565},"2025-03-11",{"date":569,"type":555},"2027-08-11",{"name":5,"class":6},29]