[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100344114":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":44,"centralContacts":37,"locations":55,"responsibleParty":178,"collaborators":180,"id":191,"slug":192,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":37,"eligibilityCriteria":197,"healthyVolunteers":198,"sex":199,"minAge":37,"maxAge":200,"enrollmentInfo":201,"targetDuration":37,"studyType":204,"phases":205,"briefSummary":208,"conditions":209,"keywords":37,"overallStatus":211,"whyStopped":37,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Weight Band #1 (6 to less than 10 kg at study entry)","EXPERIMENTAL","Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC\u002FDTG\u002F3TC daily while weighing 6-\\\u003C10 kg; as their weight increased, they received higher doses consistent with their new weight band.",[13],"Drug: Abacavir (ABC)\u002FDolutegravir (DTG)\u002FLamivudine (3TC) Dispersible Tablets",{"label":15,"type":10,"description":16,"interventionNames":17},"Weight Band #2 (10 to less than 14 kg at study entry)","Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC\u002FDTG\u002F3TC daily while weighing 10-\\\u003C14 kg; as their weight increased, they received higher doses consistent with their new weight band.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Weight Band #3 (14 to less than 20 kg at study entry)","Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC\u002FDTG\u002F3TC daily while weighing 14-\\\u003C20 kg; as their weight increased, they received higher doses consistent with their new weight band.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Weight Band #4 (20 to less than 25 kg at study entry)","Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC\u002FDTG\u002F3TC daily while weighing 20-\\\u003C25 kg; as their weight increased, they received higher doses consistent with their new weight band.",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Weight Band #5 (25 kg or greater at study entry)","Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC\u002FDTG\u002F3TC daily.",[30],"Drug: Abacavir (ABC)\u002FDolutegravir (DTG)\u002FLamivudine (3TC) Immediate Release Tablets (Immediate release)",[32,38],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","Abacavir (ABC)\u002FDolutegravir (DTG)\u002FLamivudine (3TC) Dispersible Tablets","Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food",[9,15,19,23],null,{"type":33,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Abacavir (ABC)\u002FDolutegravir (DTG)\u002FLamivudine (3TC) Immediate Release Tablets (Immediate release)","Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food",[27],[43],"Triumeq",[45,49,52],{"name":46,"affiliation":47,"role":48},"Patricia Flynn, MD","St. Jude Children's Research Hospital","STUDY_CHAIR",{"name":50,"affiliation":51,"role":48},"Helena Rabie, MBChB, MMED, FCPaed","University of Stellenbosch",{"name":53,"affiliation":54,"role":48},"Jennifer Kiser, PharmD, PhD","University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences",[56,69,79,89,95,105,115,120,132,138,148,153,165,170],{"facility":57,"status":37,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":37},"David Geffen School of Medicine at UCLA NICHD CRS","Los Angeles","California","90095-1752","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-118.24368,34.05223,{"lat":67,"lon":66},{"facility":70,"status":37,"city":71,"state":72,"zip":73,"country":61,"countryCode":62,"cosmosGeoPoint":74,"geoPoint":78,"contacts":37},"Univ. of Colorado Denver NICHD CRS","Aurora","Colorado","80045",{"type":64,"coordinates":75},[76,77],-104.83192,39.72943,{"lat":77,"lon":76},{"facility":80,"status":37,"city":81,"state":82,"zip":83,"country":61,"countryCode":62,"cosmosGeoPoint":84,"geoPoint":88,"contacts":37},"Rush Univ. Cook County Hosp. Chicago NICHD CRS","Chicago","Illinois","60612",{"type":64,"coordinates":85},[86,87],-87.65005,41.85003,{"lat":87,"lon":86},{"facility":90,"status":37,"city":81,"state":82,"zip":91,"country":61,"countryCode":62,"cosmosGeoPoint":92,"geoPoint":94,"contacts":37},"Lurie Children's Hospital of Chicago (LCH) CRS","60614-3393",{"type":64,"coordinates":93},[86,87],{"lat":87,"lon":86},{"facility":96,"status":37,"city":97,"state":98,"zip":99,"country":61,"countryCode":62,"cosmosGeoPoint":100,"geoPoint":104,"contacts":37},"St. Jude Children's Research Hospital CRS","Memphis","Tennessee","38105-3678",{"type":64,"coordinates":101},[102,103],-90.04898,35.14953,{"lat":103,"lon":102},{"facility":106,"status":37,"city":107,"state":37,"zip":37,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":114,"contacts":37},"Gaborone CRS","Gaborone","Botswana","BW",{"type":64,"coordinates":111},[112,113],25.90859,-24.65451,{"lat":113,"lon":112},{"facility":116,"status":37,"city":107,"state":37,"zip":37,"country":108,"countryCode":109,"cosmosGeoPoint":117,"geoPoint":119,"contacts":37},"Molepolole CRS",{"type":64,"coordinates":118},[112,113],{"lat":113,"lon":112},{"facility":121,"status":37,"city":122,"state":123,"zip":124,"country":125,"countryCode":126,"cosmosGeoPoint":127,"geoPoint":131,"contacts":37},"Soweto IMPAACT CRS","Johannesburg","Gauteng","1862","South Africa","ZA",{"type":64,"coordinates":128},[129,130],28.04363,-26.20227,{"lat":130,"lon":129},{"facility":133,"status":37,"city":122,"state":123,"zip":134,"country":125,"countryCode":126,"cosmosGeoPoint":135,"geoPoint":137,"contacts":37},"Wits RHI Shandukani Research Centre CRS","2001",{"type":64,"coordinates":136},[129,130],{"lat":130,"lon":129},{"facility":139,"status":37,"city":140,"state":141,"zip":142,"country":125,"countryCode":126,"cosmosGeoPoint":143,"geoPoint":147,"contacts":37},"Umlazi CRS","Umlazi","KwaZulu-Natal","4066",{"type":64,"coordinates":144},[145,146],30.88333,-29.96667,{"lat":146,"lon":145},{"facility":149,"status":37,"city":150,"state":151,"zip":152,"country":125,"countryCode":126,"cosmosGeoPoint":37,"geoPoint":37,"contacts":37},"Famcru Crs","Tygerberg","Western Cape","7505",{"facility":154,"status":37,"city":155,"state":156,"zip":157,"country":158,"countryCode":159,"cosmosGeoPoint":160,"geoPoint":164,"contacts":37},"Siriraj Hospital, Mahidol University NICHD CRS","Bangkok","Bangkoknoi","10700","Thailand","TH",{"type":64,"coordinates":161},[162,163],100.50144,13.75398,{"lat":163,"lon":162},{"facility":166,"status":37,"city":167,"state":168,"zip":169,"country":158,"countryCode":159,"cosmosGeoPoint":37,"geoPoint":37,"contacts":37},"Chiangrai Prachanukroh Hospital NICHD CRS","Changklan, Muang","Chiang Mai","50100",{"facility":171,"status":37,"city":168,"state":37,"zip":172,"country":158,"countryCode":159,"cosmosGeoPoint":173,"geoPoint":177,"contacts":37},"Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS","50200",{"type":64,"coordinates":174},[175,176],98.98468,18.79038,{"lat":176,"lon":175},{"type":179,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[181,184,186,188],{"name":182,"class":183},"International Maternal Pediatric Adolescent AIDS Clinical Trials Group","NETWORK",{"name":185,"class":6},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)",{"name":187,"class":6},"National Institute of Mental Health (NIMH)",{"name":189,"class":190},"ViiV Healthcare","INDUSTRY","100344114","phase-1-the-pharmacokinetics-safety-and-tolerability-of-abacavirdolutegravirlamivudine-dispersible-and-immediate-release-tablets-in-hiv-1-infected-children-less-than-12-years-of-age-100344114",true,"NCT03760458","The Pharmacokinetics, Safety, and Tolerability of Abacavir\u002FDolutegravir\u002FLamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age","Phase I\u002FII Study of the Pharmacokinetics, Safety, and Tolerability of Abacavir\u002FDolutegravir\u002FLamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age","Inclusion Criteria:\n\n* Weight 6 kg to less than 40 kg at entry\n* Antiretroviral therapy (ART)-naïve at entry or has been taking a stable ART regimen for at least six consecutive months at entry\n\n  * Note: For ART-naïve children, receipt of antiretroviral (ARV) prophylaxis prior to diagnosis of HIV infection is permitted. For these children, ascertainment of this criterion may be based on parent or guardian report only, but available medical records should also be reviewed in relation to this criterion.\n  * Note: For ART-experienced children (on a stable ART regimen), dose and formulation changes (e.g., for growth) within the six months prior to entry are permitted. For these children, ascertainment of this criterion must be based on medical records.\n* For ART-experienced children (on a stable ART regimen), has had a suppressed HIV viral load (HIV-1 RNA less than 200 copies\u002FmL) for at least six consecutive months prior to entry\n\n  * Note: To fulfill this criterion, at least two documented HIV-1 RNA results less than 200 copies\u002FmL must be available, one based on a specimen collected at least six months prior to entry and one based on a specimen collected within 30 days prior to entry.\n  * Note: Any documented HIV-1 RNA result greater than or equal to 200 copies\u002FmL based on a specimen collected within six months prior to entry is exclusionary (see exclusion criterion below).\n* At screening, has normal, Grade 1, or Grade 2 laboratory test results for all of the following, based on testing of specimens collected within 30 days prior to entry and grading per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (refer to the study protocol for guidance on severity grading):\n\n  * Hemoglobin (greater than or equal to 8.5 g\u002FdL or greater than or equal to 5.25 mmol\u002FL)\n  * Absolute neutrophil count (greater than or equal to 600 cells\u002Fmm\\^3 or greater than or equal to 0.600 x 10\\^9 cells\u002FL)\n  * Platelet count (greater than or equal to 50,000 cells\u002Fmm\\^3 or greater than or equal to 50.00 x 10\\^9 cells\u002FL)\n  * Estimated glomerular filtration rate (eGFR; bedside Schwartz formula; greater than or equal to 60 ml\u002Fmin\u002F1.73 m\\^2)\n  * Alanine transaminase (ALT) (less than 5.0 x ULN)\n  * Aspartate aminotransferase (AST) (less than 5.0 x ULN)\n  * Total bilirubin (less than 2.6 x ULN)\n  * Direct bilirubin (less than or equal to ULN)\n  * Note: Laboratory tests may be repeated during the screening period (i.e., within 30 days prior to entry), with the latest results used for eligibility determination.\n  * Note: For treatment-experienced children on an atazanavir-containing ART regimen, Grade 3 or higher total bilirubin is permitted.\n* At screening, has a negative test result for hepatitis B surface antigen based on testing of a specimen collected within 30 days prior to entry\n* Confirmed HIV-1-infection based on documented testing of two samples collected at different time points:\n\n  * Sample #1 may be tested using any of the following:\n\n    * Two rapid antibody tests from different manufacturers or based on different principles and epitopes\n    * One enzyme immunoassay OR Western Blot OR immunofluorescence assay OR chemiluminescence assay\n    * One HIV DNA polymerase chain reaction (PCR)\\*\n    * One quantitative HIV RNA PCR (above the limit of detection of the assay)\\*\n    * One qualitative HIV RNA PCR\\*\n    * One HIV total nucleic acid test\\*\n  * Sample #2 may be tested using any of the following:\n\n    * Rapid antibody test. If this option is used in combination with two rapid tests for Sample #1, at least one of the three rapid tests must be United States Food and Drug Administration (FDA)-approved, and the third rapid test must be from a third manufacturer or based on a third principle or epitope.\n    * One enzyme immunoassay OR Western Blot OR immunofluorescence assay OR chemiluminescence assay\n    * One HIV DNA PCR\\*\n    * One quantitative HIV RNA PCR (above the limit of detection of the assay)\\*\n    * One qualitative HIV RNA PCR\\*\n    * One HIV total nucleic acid test\\*\n  * For participants who are less than two years of age, or who are two years of age and older with any exposure to breast milk in the past 28 days, HIV-1 infection must be confirmed using the tests indicated above with an asterisk (\\*) for Sample #1 and Sample #2.\n  * Whole blood, plasma, or serum samples must be tested. If both samples are tested using antibody tests, at least one of the samples must be tested in a laboratory that operates according to Good Clinical Laboratory Practice guidelines and participates in an appropriate external quality assurance program. If nucleic acid testing is used, at least one test must be performed in a Clinical Laboratory Improvement Amendments (CLIA) certified (for US sites) or Virology Quality Assurance (VQA) certified (for non-US sites) laboratory. For tests performed in other settings, adequate source documentation including the date of specimen collection, date of testing, test performed, and test result must be available. FDA approved testing methods should be used when possible.\n* HLA-B\\*5701-negative based on documented testing at any time prior to entry\n\n  * Note: Documented testing is required even if the potential participant has received ABC prior to study entry.\n* For females of reproductive potential (defined as having experienced menarche), not pregnant based on testing performed at screening\n* For females of reproductive potential who are engaging in sexual activity that could lead to pregnancy, willing to use two methods of contraception while receiving study drug, based on participant and parent or guardian report at entry\n\n  * One of the two methods must be highly effective; highly effective methods include surgical sterilization (i.e., hysterectomy, bilateral oophorectomy, tubal ligation, or salpingectomy) and the following:\n\n    * Contraceptive intrauterine device or intrauterine system\n    * Subdermal contraceptive implant\n    * Progestogen injections\n    * Combined estrogen and progestogen oral contraceptive pills\n    * Percutaneous contraceptive patch\n    * Contraceptive vaginal ring\n  * The highly effective method must be initiated prior to study entry. The second method should ideally be a barrier method. Male or female condom use is recommended with all other methods of contraception for dual protection against pregnancy and to avoid transmission of HIV and other sexually transmitted infections.\n* Based on parent or guardian report at entry, child is expected to be available for 48 weeks of follow-up\n* Parent or legal guardian is willing and able to provide written informed consent for child's study participation and, when applicable per local institutional review board\u002Fethics committee (IRB\u002FEC) policies and procedures, child is willing and able to provide written informed assent for study participation\n\nExclusion Criteria:\n\n* Documented resistance to ABC, DTG, or 3TC\n\n  * Note: Testing to rule out resistance is not required, and the M184V resistance mutation is not exclusionary.\n* For ART-experienced children (on a stable ART regimen), documented HIV-1 RNA result greater than or equal to 200 copies\u002FmL based on a specimen collected within six months prior to entry\n* History of any of the following as determined by the site investigator based on participant\u002Fparent\u002Fguardian report and available medical records:\n\n  * Malignancy (ever)\n  * Hypersensitivity reaction to ABC (ever)\n  * Receipt of any prohibited medication (refer to the study protocol for more information) within 30 days prior to study entry\n  * Receipt of systemic interferon or any chronic systemic immunosuppressant medication within 30 days prior to study entry\n  * Note: Systemic corticosteroids (e.g., prednisone or equivalent up to 2 mg\u002Fkg) taken for replacement or short course therapy are permitted. Intranasal or inhaled steroid use is also permitted.\n* Has any of the following as determined by the site investigator based on participant\u002Fparent\u002Fguardian report and available medical records\n\n  * Current clinical evidence of pancreatitis\n  * Currently-active tuberculosis (TB) and\u002For currently receiving rifampicin-containing TB treatment\n  * Currently-active AIDS-defining (WHO Clinical Stage 4) opportunistic infection\n* Has any documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives",false,"ALL","11 Years",{"count":202,"type":203},57,"ACTUAL","INTERVENTIONAL",[206,207],"PHASE1","PHASE2","The purpose of this study was to examine the pharmacokinetics, safety, and tolerability of abacavir\u002Fdolutegravir\u002Flamivudine dispersible and immediate release tablets in children living with HIV less than 12 years of age.",[210],"HIV Infections","COMPLETED","2023-05-30",{"date":214,"type":203},"2023-06-27",{"date":216,"type":203},"2020-09-09",{"date":218,"type":203},"2022-05-31",{"name":5,"class":6},14]