[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053741":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":14,"centralContacts":7,"locations":20,"responsibleParty":7,"collaborators":7,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":38,"acronym":7,"eligibilityCriteria":39,"healthyVolunteers":36,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":7,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":54,"whyStopped":7,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":7,"completionDateStruct":59,"leadSponsor":62,"locationsCount":64},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",null,[9,12],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"DRUG","Zidovudine",{"type":10,"name":13,"description":7,"armGroupLabels":7,"otherNames":7},"Didanosine",[15,18],{"name":16,"affiliation":7,"role":17},"PA Pizzo","STUDY_CHAIR",{"name":19,"affiliation":7,"role":17},"RN Husson",[21],{"facility":22,"status":7,"city":23,"state":24,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":7},"Children's Hosp of Los Angeles\u002FUCLA Med Ctr","Los Angeles","California","900276016","United States","US",{"type":29,"coordinates":30},"Point",[31,32],-118.24368,34.05223,{"lat":32,"lon":31},"100053741","phase-1-a-phase-i-study-to-evaluate-the-safety-and-toxicity-of-the-combination-of-zidovudine-and-23-dideoxyinosine-didanosine-in-children-with-hiv-infection-100053741",false,"NCT00000652","A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 2',3'-Dideoxyinosine (Didanosine) in Children With HIV Infection","Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Corticosteroids for treatment of lymphocytic interstitial pneumonitis.\n\nConcurrent Treatment:\n\nAllowed:\n\n* Intravenous hyperalimentation.\n\nPatients must have the following:\n\n* P-2 class symptomatic HIV infection as defined by CDC OR who are asymptomatic but whose total CD4 cell count is \\\u003C 500 cells\u002Fmm3.\n* Freedom from significant active opportunistic or other infection requiring specific therapy.\n\nPart B patients:\n\n* Prior treatment with zidovudine (AZT) that was discontinued because of hematologic toxicity.\n* Availability of a parent or legal guardian who is sufficiently reliable to give informed consent and follow necessary study procedures including administration of medications and return for follow-up visits.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Critically ill, clinically unstable, or receiving drug therapy for an opportunistic or other infection.\n* History of acute or chronic pancreatitis.\n\nPatients with the following are excluded:\n\n* Critically ill, clinically unstable, or receiving drug therapy for an opportunistic or other infection.\n* History of acute or chronic pancreatitis.\n\nPrior Medication:\n\nExcluded:\n\n* Antiretroviral or other antiviral agent within 14 days of entry into study.\n* Immunomodulating agents, cytolytic chemotherapeutic agents, corticosteroids within 30 days (except for lymphocytic interstitial pneumonitis).\n\nPart A patients:\n\n* Zidovudine (AZT) or didanosine (ddI).\n\nPart B patients:\n\n* Didanosine (ddI).\n\nPrior Treatment:\n\nExcluded:\n\n* Radiation therapy within 30 days.\n* Intravenous immunoglobulin preparations within 14 days of entry into study.","ALL","3 Months","18 Years",{"count":44,"type":7},85,"INTERVENTIONAL",[47],"PHASE1","To assess the safety and tolerance of the combination of zidovudine (AZT) and didanosine (ddI) in children with HIV infection.\n\nNew approaches to using available agents may provide increased or improved treatment options for AIDS. Combination therapy is expected to play a major role in improving survival and quality of life for HIV-infected individuals. AZT and ddI are two agents that have been most extensively evaluated and for which the evidence for antiretroviral effectiveness is strongest.",[50],"HIV Infections",[13,52,53,11],"Drug Evaluation","Drug Therapy, Combination","COMPLETED","2012-10-31",{"date":57,"type":58},"2012-11-01","ESTIMATED",{"date":60,"type":61},"1995-11","ACTUAL",{"name":63,"class":6},"National Cancer Institute (NCI)",1]