[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100081097":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":49,"centralContacts":42,"locations":54,"responsibleParty":87,"collaborators":89,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":42,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":42,"studyType":108,"phases":109,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":118,"whyStopped":42,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",[8,17,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"A, Stage 1","EXPERIMENTAL","Tablet containing d4T, 3TC, and NVP taken orally twice daily for the first 4 weeks, then liquid formulations of d4T, 3TC, and NVP taken orally twice daily for the final 4 weeks",[13,14,15,16],"Drug: Lamivudine, nevirapine, and stavudine fixed-dose tablet","Drug: Lamivudine","Drug: Nevirapine","Drug: Stavudine",{"label":18,"type":10,"description":19,"interventionNames":20},"A, Stage 2","Tablet containing d4T, 3TC, and NVP taken orally twice daily for 4 weeks, then liquid formulations of d4T, 3TC, and NVP taken orally twice daily for 4 weeks",[13,14,15,16],{"label":22,"type":10,"description":23,"interventionNames":24},"B, Stage 1","Liquid formulations of d4T, 3TC, and NVP taken orally twice daily for 2 weeks, then tablet containing d4T, 3TC, and NVP taken orally twice daily for 2 weeks",[13,14,15,16],{"label":26,"type":10,"description":27,"interventionNames":28},"B, Stage 2","Liquid formulations of d4T, 3TC, and NVP taken orally twice daily for 4 weeks, then tablet containing d4T, 3TC, and NVP taken orally twice daily for 4 weeks",[13,14,15,16],[30,38,43,46],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Lamivudine, nevirapine, and stavudine fixed-dose tablet","7 mg d4T, 30 mg 3TC, 50 mg NVP tablet",[9,18,22,26],[36,37],"GPO-Vir","d4T\u002F3TC\u002FNVP",{"type":31,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Lamivudine","Dosage dependent on weight. More information on this criterion can be found in the protocol.",[9,18,22,26],null,{"type":31,"name":44,"description":40,"armGroupLabels":45,"otherNames":42},"Nevirapine",[9,18,22,26],{"type":31,"name":47,"description":40,"armGroupLabels":48,"otherNames":42},"Stavudine",[9,18,22,26],[50],{"name":51,"affiliation":52,"role":53},"Nirun Vanprapar, MD","Pediatric Infectious Unit, Department of Pediatrics, Siriraj Hopstial, Mahidol University","STUDY_CHAIR",[55,68,74,83],{"facility":56,"status":42,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":42},"Queen Sirikit National Institute of Child Health, Pediatric Infectious Unit","Bangkok","Ratchathewi","10400","Thailand","TH",{"type":63,"coordinates":64},"Point",[65,66],100.50144,13.75398,{"lat":66,"lon":65},{"facility":69,"status":42,"city":57,"state":58,"zip":70,"country":60,"countryCode":61,"cosmosGeoPoint":71,"geoPoint":73,"contacts":42},"Siriraj Hospital Mahidol University CRS","10700",{"type":63,"coordinates":72},[65,66],{"lat":66,"lon":65},{"facility":75,"status":42,"city":76,"state":42,"zip":77,"country":60,"countryCode":61,"cosmosGeoPoint":78,"geoPoint":82,"contacts":42},"Chiang Mai University Pediatrics-Obstetrics CRS","Chiang Mai","50200",{"type":63,"coordinates":79},[80,81],98.98468,18.79038,{"lat":81,"lon":80},{"facility":84,"status":42,"city":85,"state":42,"zip":86,"country":60,"countryCode":61,"cosmosGeoPoint":42,"geoPoint":42,"contacts":42},"Chonburi Hosp. CRS","Chonburri","20000 TH",{"type":88,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[90,92],{"name":91,"class":6},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)",{"name":93,"class":94},"International Maternal Pediatric Adolescent AIDS Clinical Trials Group","NETWORK","100081097","phase-1-drug-levels-of-tablet-and-liquid-forms-of-lamivudine-nevirapine-and-stavudine-in-hiv-infected-thai-children-100081097",false,"NCT00312091","Drug Levels of Tablet and Liquid Forms of Lamivudine, Nevirapine, and Stavudine in HIV Infected Thai Children","A Phase I\u002FII Comparative Pharmacokinetic Study of the Fixed-Dose Combination (FDC) of Stavudine (d4T), Lamivudine (3TC), and Nevirapine (NVP) as GPO-VIR Pediatric Chewable Tablets Versus the Individual Liquid Formulations in HIV Infected Children 6 Months and Older to Less Than 13 Years of Age in Thailand","Inclusion Criteria for Stages 1 and 2:\n\n* HIV infected\n* On a highly active antiretroviral regimen (HAART) including NVP and 2 nucleoside reverse transcriptase inhibitors and receiving a maintenance of NVP for at least 4 weeks prior to study entry and taking the current recommended oral dose every 12 hours\n* Willing to swallow or chew study drugs\n* Willing to be hospitalized for the 12 hour PK studies\n* Willing to use acceptable forms of contraception\n* Parent or guardian willing to provide informed consent\n\nInclusion Criteria for Stage 1:\n\n* Between 12 to 30 kg (26.5 to 66.1 lbs)\n\nInclusion Criteria for Stage 2:\n\n* Between 6 to 30 kg (13.2 to 66.1 lbs)\n\nExclusion Criteria:\n\n* Certain abnormal laboratory values\n* Require certain medications\n* Grade 2 or greater vomiting within 30 days prior to study entry\n* Grade 2 or greater diarrhea within 30 days prior to study entry\n* History of immunological failure (CD4 percentage decrease of more than 30% within a 6-month period for children 6 years or younger OR CD4 cell count decrease of more than 30% within a 6-month period for children older than 6 years)\n* Current treatment for acute serious bacterial, viral, or opportunistic infection\n* History of dose-limiting toxicity requiring treatment discontinuation of any of the study drugs\n* Known hypersensitivity to any of the study drugs\n* Current surgical or medical problem affecting gastrointestinal motility or absorption (e.g., ileus, ulcerative colitis) or liver function\n* Treatment with immune modulators or myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic drugs within 30 days prior to study entry. Patients who have received therapeutic vaccines are not excluded.\n* Treatment with experimental drugs within 30 days of study entry\n* Acute inflammation of the liver\n* Chemotherapy for active cancer\n* Any clinically significant diseases other than HIV infection or clinically significant findings that, in the investigator's opinion, may interfere with the study\n* Inability to provide a reliable means of contact (e.g., telephone number)\n* Pregnancy","ALL","6 Months","13 Years",{"count":106,"type":107},44,"ACTUAL","INTERVENTIONAL",[110,111],"PHASE1","PHASE2","The purpose of this study is to compare the blood levels, absorption, and breakdown of lamivudine (3TC), nevirapine (NVP), and stavudine (d4T) in a fixed-dose tablet to that of the individual liquid formulations of the same anti-HIV drugs in HIV infected Thai children.",[114],"HIV Infections",[116,117],"Pharmacokinetics","Treatment Experienced","COMPLETED","2021-10-29",{"date":121,"type":107},"2021-11-02",{"date":123,"type":42},"2006-12",{"date":125,"type":107},"2008-09",{"name":5,"class":6},4]