Nctid:
NCT00000653
Payload:
{"FullStudy"=>{"Rank"=>474660, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 06, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000007239", "ConditionMeshTerm"=>"Infections"}, {"ConditionMeshId"=>"D000003141", "ConditionMeshTerm"=>"Communicable Diseases"}, {"ConditionMeshId"=>"D000015658", "ConditionMeshTerm"=>"HIV Infections"}, {"ConditionMeshId"=>"D000000163", "ConditionMeshTerm"=>"Acquired Immunodeficiency Syndrome"}, {"ConditionMeshId"=>"D000018450", "ConditionMeshTerm"=>"Disease Progression"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000020969", "ConditionAncestorTerm"=>"Disease Attributes"}, {"ConditionAncestorId"=>"D000010335", "ConditionAncestorTerm"=>"Pathologic Processes"}, {"ConditionAncestorId"=>"D000086982", "ConditionAncestorTerm"=>"Blood-Borne Infections"}, {"ConditionAncestorId"=>"D000015229", "ConditionAncestorTerm"=>"Sexually Transmitted Diseases, Viral"}, {"ConditionAncestorId"=>"D000012749", "ConditionAncestorTerm"=>"Sexually Transmitted Diseases"}, {"ConditionAncestorId"=>"D000016180", "ConditionAncestorTerm"=>"Lentivirus Infections"}, {"ConditionAncestorId"=>"D000012192", "ConditionAncestorTerm"=>"Retroviridae Infections"}, {"ConditionAncestorId"=>"D000012327", "ConditionAncestorTerm"=>"RNA Virus Infections"}, {"ConditionAncestorId"=>"D000014777", "ConditionAncestorTerm"=>"Virus Diseases"}, {"ConditionAncestorId"=>"D000091662", "ConditionAncestorTerm"=>"Genital Diseases"}, {"ConditionAncestorId"=>"D000091642", "ConditionAncestorTerm"=>"Urogenital Diseases"}, {"ConditionAncestorId"=>"D000007153", "ConditionAncestorTerm"=>"Immunologic Deficiency Syndromes"}, {"ConditionAncestorId"=>"D000007154", "ConditionAncestorTerm"=>"Immune System Diseases"}, {"ConditionAncestorId"=>"D000012897", "ConditionAncestorTerm"=>"Slow Virus Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M6058", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafAsFound"=>"Infection", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M9973", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafAsFound"=>"Infection", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M16045", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17940", "ConditionBrowseLeafName"=>"HIV Infections", "ConditionBrowseLeafAsFound"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M9889", "ConditionBrowseLeafName"=>"Immunologic Deficiency Syndromes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3212", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafAsFound"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M20249", "ConditionBrowseLeafName"=>"Disease Progression", "ConditionBrowseLeafAsFound"=>"Progressive Disease", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M3425", "ConditionBrowseLeafName"=>"AIDS-Related Complex", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M22390", "ConditionBrowseLeafName"=>"Disease Attributes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2594", "ConditionBrowseLeafName"=>"Blood-Borne Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15248", "ConditionBrowseLeafName"=>"Sexually Transmitted Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17623", "ConditionBrowseLeafName"=>"Sexually Transmitted Diseases, Viral", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18330", "ConditionBrowseLeafName"=>"Lentivirus Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14716", "ConditionBrowseLeafName"=>"Retroviridae Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17212", "ConditionBrowseLeafName"=>"Virus Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14839", "ConditionBrowseLeafName"=>"RNA Virus Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2877", "ConditionBrowseLeafName"=>"Genital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2876", "ConditionBrowseLeafName"=>"Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9890", "ConditionBrowseLeafName"=>"Immune System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15390", "ConditionBrowseLeafName"=>"Slow Virus Diseases", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000016047", "InterventionMeshTerm"=>"Zalcitabine"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000963", "InterventionAncestorTerm"=>"Antimetabolites"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000018894", "InterventionAncestorTerm"=>"Reverse Transcriptase Inhibitors"}, {"InterventionAncestorId"=>"D000019384", "InterventionAncestorTerm"=>"Nucleic Acid Synthesis Inhibitors"}, {"InterventionAncestorId"=>"D000004791", "InterventionAncestorTerm"=>"Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000000998", "InterventionAncestorTerm"=>"Antiviral Agents"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"InterventionAncestorId"=>"D000019380", "InterventionAncestorTerm"=>"Anti-HIV Agents"}, {"InterventionAncestorId"=>"D000044966", "InterventionAncestorTerm"=>"Anti-Retroviral Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M18236", "InterventionBrowseLeafName"=>"Zalcitabine", "InterventionBrowseLeafAsFound"=>"Neurology", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3971", "InterventionBrowseLeafName"=>"Antimetabolites", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20625", "InterventionBrowseLeafName"=>"Reverse Transcriptase Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7641", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4004", "InterventionBrowseLeafName"=>"Antiviral Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3904", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M21040", "InterventionBrowseLeafName"=>"Anti-HIV Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M25118", "InterventionBrowseLeafName"=>"Anti-Retroviral Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"140"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"October 2021", "CompletionDateStruct"=>{"CompletionDate"=>"June 1995", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"October 26, 2021", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"August 30, 2001", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"October 27, 2021", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"August 31, 2001", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Zalcitabine", "Drug Evaluation", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex"]}, "ConditionList"=>{"Condition"=>["HIV Infections"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"21037891", "ReferenceType"=>"background", "ReferenceCitation"=>"Perrier M, Schwarz T, Gonzalez O, Brounts S. Squamous cell carcinoma invading the right temporomandibular joint in a Belgian mare. Can Vet J. 2010 Aug;51(8):885-7."}, {"ReferenceType"=>"background", "ReferenceCitation"=>"Spector SA, Blanchard S, Connor EM, Salgo MP, McNamara J. Results of a clinical trial comparing two doses of 2'3'-dideoxycytidine (ddC) in the treatment of children with symptomatic human immunodeficiency virus (HIV) infection who were intolerant or had failed zidovudine (ZDV) therapy (ACTG 138). The Pediatric AIDS Clinical Trials Group. American Pediatric Society 104th annual meeting and Society for Pediatric Research 63rd annual meeting; 1994 May 2-5; Seattle. Pediatr AIDS HIV Infect. 1994 Oct;5(5):323 (unnumbered abstract)"}]}}, "DescriptionModule"=>{"BriefSummary"=>"To evaluate and compare the long-term (48-177 weeks) safety, tolerance, and efficacy of two doses of zalcitabine ( dideoxycytidine; ddC ) taken orally every 8 hours in children with symptomatic HIV infection who have one of the following: intolerance to zidovudine ( AZT ) (development of toxicity during prolonged AZT therapy), demonstrated disease progression after 6 months of AZT therapy, OR both AZT intolerance and disease progression after 6 months of AZT therapy.\n\nAs useful as AZT appears to be in the treatment of patients infected with HIV, it is associated with significant toxicity in some patients, and it does not prevent ultimate progression to AIDS and eventual mortality. Thus, there is a clear need for new antiretroviral drugs, and ddC is one such promising agent.", "DetailedDescription"=>"As useful as AZT appears to be in the treatment of patients infected with HIV, it is associated with significant toxicity in some patients, and it does not prevent ultimate progression to AIDS and eventual mortality. Thus, there is a clear need for new antiretroviral drugs, and ddC is one such promising agent.\n\nPatients receive oral ddC for 48 to 177 weeks."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"18 years", "MinimumAge"=>"3 months", "StdAgeList"=>{"StdAge"=>["Child", "Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\nProcrit.\nAmphotericin B (1 mg/kg up to 5 days/week).\nProphylaxis treatment as per ACTG recommendations for Pneumocystis carinii pneumonia.\nAcyclovir (up to 1000 mg/day PO; for > 1000 mg/day PO or for any IV dose, suggest interrupting ddC).\nKetoconazole (up to 10 mg/kg/day).\nNystatin.\nAspirin, acetaminophen, sedatives, and barbiturates (for up to 72 hours).\nIsoniazid (INH), if there is no evidence of peripheral neuropathy at entry. Children should receive pyridoxine, 25\n50 mg/day to avoid possible INH-associated neuropathy.\nTrimethoprim / sulfamethoxazole (T/S).\nImmunoglobulin therapy.\nAerosolized pentamidine.\nDrugs with little nephro-, hepato-, cytotoxicity that the patient has been taking and tolerating well for an ongoing condition.\n\nConcurrent Treatment:\n\nAllowed:\n\nImmunoglobulin therapy.\nNutritional support (for children with wasting syndrome and/or malnutritional) including hyperalimentation (TPN) of dietary supplements.\n\nAMENDED:\n\nPatients enrolled in ACTG 051 may participate in ACTG 138 if they show intolerance to AZT or show disease progression after 6 months of AZT therapy and meet entry criteria for the study.\n\nORIGINAL design:\n\nPatients enrolled in ACTG protocols 051 or 128 must meet study end points or meet protocol definitions for being permanently off zidovudine (AZT) before enrolling in this protocol.\n\nPatients must have the following:\n\nAbsence of acute opportunistic infection at time of entry.\nHowever, if patient is successfully treated for opportunistic infection and has remained stable for 2 weeks after treatment, the patient is then allowed to enter the study. Children receiving maintenance therapy for > 4 weeks are eligible.\nParent or guardian available to give written informed consent.\n\nAllowed at time of study entry:\n\nProphylaxis treatment as per ACTG recommendations, for Pneumocystis carinii pneumonia (PCP).\nImmunoglobulin therapy.\n\nPrior Medication:\n\nAMENDED:\n\nAZT or ddI up until study entry, other antiretrovirals up until 4 weeks of study entry\n\nAllowed:\n\nZidovudine (AZT) within 4 weeks of entry.\nDideoxyinosine (ddI) within 43 weeks of entry if no peripheral neuropathy has been observed while receiving ddI.\nOther toxicities observed while on ddI must resolve to level 2 or better before patient can begin treatment with ddC.\nVitamin, folate, iron supplements.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nAMENDED:\n\n04-25-91 Additional excluded symptoms and conditions:\nSymptomatic cardiomyopathy.\nSeizures which are not well controlled by ongoing anticonvulsant therapy.\nActive malignancy requiring concomitant chemotherapy.\nSymptomatic pancreatitis.\nGrade I or greater peripheral neuropathy.\nReceiving concomitant zidovudine (AZT).\nPatients with the following conditions or symptoms are excluded:\nAcute bacterial infections requiring IV or oral antibiotic treatment at time of entry.\nKnown hypersensitivity to dideoxycytidine (ddC).\n\nConcurrent Medication:\n\nExcluded:\n\nOther antiviral agents, biological modifiers, and investigational medications.\nDrugs with potential to cause peripheral neuropathy, including chloramphenicol, iodoquinol, phenytoin, ethionamide, gold, ribavirin, vincristine, cisplatin, dapsone, disulfiram, glutethimide, hydralazine, metronidazole, nitrofurantoin.\n\nPatients with the following are excluded:\n\nAcute bacterial infections requiring IV or oral antibiotic treatment at time of entry.\nKnown hypersensitivity to dideoxycytidine (ddC).\nActive opportunistic infection requiring treatment with an excluded concomitant medication.\n\nPrior Medication:\n\nExcluded:\n\nAntiretroviral agents (other than zidovudine (AZT) or didanosine (ddI)) within 4 weeks of entry.\nImmunomodulating agents such as interferons, isoprinosine, or interleukin-2 within 2 weeks of entry.\nAny other experimental therapy, drugs that cause prolonged neutropenia, significant nephrotoxicity, or peripheral neuropathy within 1 week of entry."}, "IdentificationModule"=>{"NCTId"=>"NCT00000653", "BriefTitle"=>"A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT", "OrgStudyIdInfo"=>{"OrgStudyId"=>"ACTG 138"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"11113", "SecondaryIdType"=>"Registry Identifier", "SecondaryIdDomain"=>"DAIDS ES Registry Number"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Zalcitabine", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"90095", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS"}, {"LocationZip"=>"94609", "LocationCity"=>"Oakland", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab."}, {"LocationZip"=>"92093", "LocationCity"=>"San Diego", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"UCSD Maternal, Child, and Adolescent HIV CRS"}, {"LocationZip"=>"94143", "LocationCity"=>"San Francisco", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"UCSF Pediatric AIDS CRS"}, {"LocationZip"=>"20010", "LocationCity"=>"Washington", "LocationState"=>"District of Columbia", "LocationCountry"=>"United States", "LocationFacility"=>"Children's National Med. Ctr., ACTU"}, {"LocationZip"=>"33161", "LocationCity"=>"Miami", "LocationState"=>"Florida", "LocationCountry"=>"United States", "LocationFacility"=>"Univ. of Miami Ped. Perinatal HIV/AIDS CRS"}, {"LocationZip"=>"30303", "LocationCity"=>"Atlanta", "LocationState"=>"Georgia", "LocationCountry"=>"United States", "LocationFacility"=>"Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases"}, {"LocationZip"=>"60612", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"Cook County Hosp."}, {"LocationZip"=>"60612", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"Univ. of Illinois College of Medicine at Chicago, Dept. of Peds."}, {"LocationZip"=>"60614", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"Chicago Children's CRS"}, {"LocationCity"=>"New Orleans", "LocationState"=>"Louisiana", "LocationCountry"=>"United States", "LocationFacility"=>"Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU"}, {"LocationCity"=>"New Orleans", "LocationState"=>"Louisiana", "LocationCountry"=>"United States", "LocationFacility"=>"Tulane/LSU Maternal/Child CRS"}, {"LocationZip"=>"21201", "LocationCity"=>"Baltimore", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology"}, {"LocationZip"=>"21287", "LocationCity"=>"Baltimore", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases"}, {"LocationZip"=>"02115", "LocationCity"=>"Boston", "LocationState"=>"Massachusetts", "LocationCountry"=>"United States", "LocationFacility"=>"HMS - Children's Hosp. Boston, Div. of Infectious Diseases"}, {"LocationZip"=>"02118", "LocationCity"=>"Boston", "LocationState"=>"Massachusetts", "LocationCountry"=>"United States", "LocationFacility"=>"BMC, Div. of Ped Infectious Diseases"}, {"LocationZip"=>"01199", "LocationCity"=>"Springfield", "LocationState"=>"Massachusetts", "LocationCountry"=>"United States", "LocationFacility"=>"Baystate Health, Baystate Med. Ctr."}, {"LocationZip"=>"01655", "LocationCity"=>"Worcester", "LocationState"=>"Massachusetts", "LocationCountry"=>"United States", "LocationFacility"=>"WNE Maternal Pediatric Adolescent AIDS CRS"}, {"LocationCity"=>"New Brunswick", "LocationState"=>"New Jersey", "LocationCountry"=>"United States", "LocationFacility"=>"UMDNJ - Robert Wood Johnson"}, {"LocationZip"=>"10456", "LocationCity"=>"Bronx", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Bronx-Lebanon Hosp. IMPAACT CRS"}, {"LocationZip"=>"11203", "LocationCity"=>"Brooklyn", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS"}, {"LocationCity"=>"Great Neck", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"North Shore-Long Island Jewish Health System, Dept. of Peds."}, {"LocationZip"=>"11042", "LocationCity"=>"New Hyde Park", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Schneider Children's Hosp., Div. of Infectious Diseases"}, {"LocationZip"=>"10016", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"NYU Med. Ctr., Dept. of Medicine"}, {"LocationZip"=>"10029", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Metropolitan Hosp. NICHD CRS"}, {"LocationZip"=>"10032", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Columbia IMPAACT CRS"}, {"LocationZip"=>"10037", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Harlem Hosp. Ctr. NY NICHD CRS"}, {"LocationZip"=>"14642", "LocationCity"=>"Rochester", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Univ. of Rochester ACTG CRS"}, {"LocationZip"=>"27599", "LocationCity"=>"Chapel Hill", "LocationState"=>"North Carolina", "LocationCountry"=>"United States", "LocationFacility"=>"UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases"}, {"LocationZip"=>"27710", "LocationCity"=>"Durham", "LocationState"=>"North Carolina", "LocationCountry"=>"United States", "LocationFacility"=>"DUMC Ped. CRS"}, {"LocationZip"=>"19134", "LocationCity"=>"Philadelphia", "LocationState"=>"Pennsylvania", "LocationCountry"=>"United States", "LocationFacility"=>"St. Christopher's Hosp. for Children"}, {"LocationZip"=>"77030", "LocationCity"=>"Houston", "LocationState"=>"Texas", "LocationCountry"=>"United States", "LocationFacility"=>"Texas Children's Hosp. CRS"}, {"LocationZip"=>"00619", "LocationCity"=>"Bayamon", "LocationCountry"=>"Puerto Rico", "LocationFacility"=>"Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds."}, {"LocationZip"=>"00936", "LocationCity"=>"San Juan", "LocationCountry"=>"Puerto Rico", "LocationFacility"=>"Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS"}, {"LocationCity"=>"San Juan", "LocationCountry"=>"Puerto Rico", "LocationFacility"=>"San Juan City Hosp. PR NICHD CRS"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Spector SA", "OverallOfficialRole"=>"Study Chair"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"Hoffmann-La Roche", "CollaboratorClass"=>"INDUSTRY"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
