Nctid:
NCT00000872
Payload:
{"FullStudy"=>{"Rank"=>474741, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023", "RemovedCountryList"=>{"RemovedCountry"=>["Puerto Rico"]}}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000007239", "ConditionMeshTerm"=>"Infections"}, {"ConditionMeshId"=>"D000015658", "ConditionMeshTerm"=>"HIV Infections"}, {"ConditionMeshId"=>"D000000163", "ConditionMeshTerm"=>"Acquired Immunodeficiency Syndrome"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000003141", "ConditionAncestorTerm"=>"Communicable Diseases"}, {"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"=>"M9973", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafAsFound"=>"Infection", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M6058", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17212", "ConditionBrowseLeafName"=>"Virus Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17940", "ConditionBrowseLeafName"=>"HIV Infections", "ConditionBrowseLeafAsFound"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M3212", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafAsFound"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M16045", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9889", "ConditionBrowseLeafName"=>"Immunologic Deficiency Syndromes", "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"=>"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"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000019259", "InterventionMeshTerm"=>"Lamivudine"}, {"InterventionMeshId"=>"D000015215", "InterventionMeshTerm"=>"Zidovudine"}, {"InterventionMeshId"=>"D000019829", "InterventionMeshTerm"=>"Nevirapine"}, {"InterventionMeshId"=>"C000106538", "InterventionMeshTerm"=>"Abacavir"}, {"InterventionMeshId"=>"D000018119", "InterventionMeshTerm"=>"Stavudine"}, {"InterventionMeshId"=>"D000019888", "InterventionMeshTerm"=>"Nelfinavir"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000018894", "InterventionAncestorTerm"=>"Reverse Transcriptase Inhibitors"}, {"InterventionAncestorId"=>"D000019384", "InterventionAncestorTerm"=>"Nucleic Acid Synthesis Inhibitors"}, {"InterventionAncestorId"=>"D000004791", "InterventionAncestorTerm"=>"Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000000998", "InterventionAncestorTerm"=>"Antiviral Agents"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"InterventionAncestorId"=>"D000019380", "InterventionAncestorTerm"=>"Anti-HIV Agents"}, {"InterventionAncestorId"=>"D000044966", "InterventionAncestorTerm"=>"Anti-Retroviral Agents"}, {"InterventionAncestorId"=>"D000000963", "InterventionAncestorTerm"=>"Antimetabolites"}, {"InterventionAncestorId"=>"D000065701", "InterventionAncestorTerm"=>"Cytochrome P-450 CYP3A Inducers"}, {"InterventionAncestorId"=>"D000065693", "InterventionAncestorTerm"=>"Cytochrome P-450 Enzyme Inducers"}, {"InterventionAncestorId"=>"D000017320", "InterventionAncestorTerm"=>"HIV Protease Inhibitors"}, {"InterventionAncestorId"=>"D000084762", "InterventionAncestorTerm"=>"Viral Protease Inhibitors"}, {"InterventionAncestorId"=>"D000011480", "InterventionAncestorTerm"=>"Protease Inhibitors"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M20933", "InterventionBrowseLeafName"=>"Lamivudine", "InterventionBrowseLeafAsFound"=>"Bladder", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M25118", "InterventionBrowseLeafName"=>"Anti-Retroviral Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4004", "InterventionBrowseLeafName"=>"Antiviral Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20625", "InterventionBrowseLeafName"=>"Reverse Transcriptase Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M19299", "InterventionBrowseLeafName"=>"HIV Protease Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M14033", "InterventionBrowseLeafName"=>"Protease Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M350700", "InterventionBrowseLeafName"=>"Abacavir", "InterventionBrowseLeafAsFound"=>"Depletion", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M21460", "InterventionBrowseLeafName"=>"Nelfinavir", "InterventionBrowseLeafAsFound"=>"SCH", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M17610", "InterventionBrowseLeafName"=>"Zidovudine", "InterventionBrowseLeafAsFound"=>"A 2-", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M21407", "InterventionBrowseLeafName"=>"Nevirapine", "InterventionBrowseLeafAsFound"=>"Prone", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M21040", "InterventionBrowseLeafName"=>"Anti-HIV Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M19962", "InterventionBrowseLeafName"=>"Stavudine", "InterventionBrowseLeafAsFound"=>"Trigger point", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M7641", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3904", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3971", "InterventionBrowseLeafName"=>"Antimetabolites", "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"=>{"DesignAllocation"=>"Non-Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"None (Open Label)"}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Parallel Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Anticipated", "EnrollmentCount"=>"55"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"October 2021", "CompletionDateStruct"=>{"CompletionDate"=>"January 2005", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"October 27, 2021", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"August 30, 2001", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"November 4, 2021", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"August 31, 2001", "StudyFirstPostDateType"=>"Estimate"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Antiretroviral activity of ZDV/3TC/NVP", "PrimaryOutcomeTimeFrame"=>"Throughout study"}, {"PrimaryOutcomeMeasure"=>"Durability of viral suppression", "PrimaryOutcomeTimeFrame"=>"Throughout study"}, {"PrimaryOutcomeMeasure"=>"Immune competence and HIV-1 specific immune respones with prolonged viral suppression beyond 104 weeks", "PrimaryOutcomeTimeFrame"=>"Throughout study"}, {"PrimaryOutcomeMeasure"=>"Antiretroviral activity of ZDV/3TC/NVP/1592U89 regimen", "PrimaryOutcomeTimeFrame"=>"Throughout study"}, {"PrimaryOutcomeMeasure"=>"Antiretroviral activity of d4T/3TC/NVP/NFV regimen", "PrimaryOutcomeTimeFrame"=>"Throughout study"}, {"PrimaryOutcomeMeasure"=>"Tolerance and pharmacokinetic profile of NFV", "PrimaryOutcomeTimeFrame"=>"Throughout study"}]}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Virus Replication", "HIV-1", "Drug Therapy, Combination", "Zidovudine", "Nevirapine", "Stavudine", "HIV Protease Inhibitors", "CD4 Lymphocyte Count", "Lamivudine", "RNA, Viral", "Reverse Transcriptase Inhibitors", "Anti-HIV Agents", "Viral Load", "Nelfinavir"]}, "ConditionList"=>{"Condition"=>["HIV Infections"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferenceType"=>"background", "ReferenceCitation"=>"Luzuriaga K, McManus M, Britto P, Wu HL, Lindsey J, Sullivan JL. Viral kinetics and control of replication following potent early combination antiretroviral therapy of vertical HIV-1 infection. HIV Pathog Treat Conf. 1998 Mar 13-19;52 (abstract no 2024)"}, {"ReferenceType"=>"background", "ReferenceCitation"=>"Capparelli E, Sullivan J, Mofenson L, Smith B, Graham B, Britto P, Becker M, Luzuriaga K. Pharmacokinetics (PK) of nelfinavir and its metabolite (M8) in HIV-infected infants following BID or TID administration. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 729)"}, {"ReferencePMID"=>"9847340", "ReferenceType"=>"background", "ReferenceCitation"=>"Luzuriaga K, Wu H, McManus M, Britto P, Borkowsky W, Burchett S, Smith B, Mofenson L, Sullivan JL. Dynamics of human immunodeficiency virus type 1 replication in vertically infected infants. J Virol. 1999 Jan;73(1):362-7. doi: 10.1128/JVI.73.1.362-367.1999."}, {"ReferenceType"=>"background", "ReferenceCitation"=>"Luzuriaga K, Mcmanus M, Britto P, Wu H, Lindsey J, Smith B, Mofenson L, Sullivan JL. Early combination antiretroviral therapy of vertical HIV-1 infection: viral kinetics and control of viral replication. Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:225 (abstract no LB12)"}, {"ReferencePMID"=>"11734735", "ReferenceType"=>"background", "ReferenceCitation"=>"Capparelli EV, Sullivan JL, Mofenson L, Smith E, Graham B, Britto P, Becker MI, Holland D, Connor JD, Luzuriaga K; Pediatric ACTG 356 Investigators. Pharmacokinetics of nelfinavir in human immunodeficiency virus-infected infants. Pediatr Infect Dis J. 2001 Aug;20(8):746-51. doi: 10.1097/00006454-200108000-00006."}, {"ReferencePMID"=>"15190139", "ReferenceType"=>"background", "ReferenceCitation"=>"Luzuriaga K, McManus M, Mofenson L, Britto P, Graham B, Sullivan JL; PACTG 356 Investigators. A trial of three antiretroviral regimens in HIV-1-infected children. N Engl J Med. 2004 Jun 10;350(24):2471-80. doi: 10.1056/NEJMoa032706."}, {"ReferencePMID"=>"30668843", "ReferenceType"=>"derived", "ReferenceCitation"=>"McManus M, Henderson J, Gautam A, Brody R, Weiss ER, Persaud D, Mick E, Luzuriaga K; PACTG 356 Investigators. Quantitative Human Immunodeficiency Virus (HIV)-1 Antibodies Correlate With Plasma HIV-1 RNA and Cell-associated DNA Levels in Children on Antiretroviral Therapy. Clin Infect Dis. 2019 May 2;68(10):1725-1732. doi: 10.1093/cid/ciy753."}]}}, "DescriptionModule"=>{"BriefSummary"=>"This trial tests the safety and effectiveness of the early use of combinations of anti-HIV drugs in HIV-infected infants and young children in an effort to block virus growth and preserve normal immune functions.\n\nVarious anti-HIV drug combinations need to be tested in order to find the best way to treat infants and children who have been infected with HIV during birth.", "DetailedDescription"=>"This study examines the antiretroviral activity of ZDV/3TC/NVP in vertically-infected infants and children aged 15 days up to 2 years, and ZDV/3TC/NVP/ABC in vertically-infected infants and children aged 30 days up to 2 years. This study will assess HIV-1 and CD4/CD8 T-cell kinetics, activation, and maturation. It will also test the concept that early (younger than 3 months of age) use of potent, combination antiretroviral therapy will allow the long-term control of viral replication with preservation of normal immune function. [AS PER AMENDMENT 3/11/98: This study will also examine the antiretroviral activity of ZDV/3TC/NVP/NFV in vertically infected infants and children.]\n\nThis is a 2-part Phase I/II, open-label trial in HIV-infected infants. Part A assesses the triple combination of ZDV, 3TC, and NVP. Four to eight patients are enrolled in each age cohort (Cohort 1: at least 15 days, no more than 3 months; Cohort 2: over 3 months, no more than 2 years). Part B assesses the quadruple combination of ZDV, 3TC, NVP, and ABC. Eight patients are enrolled in each age cohort (Cohort 3: at least 30 days, no more than 3 months; Cohort 4: over 3 months, no more than 2 years). [AS PER AMENDMENT 3/11/98: This study is now a 3-part Phase I/II trial. Parts A and B are as above. Part C will assess the quadruple regimen of d4T, 3TC, NVP and NFV. Up to 8 patients will be enrolled in each age cohort (Cohort 5: at least 15 days, no more than 3 months; Cohort 6: over 3 months, no more than 2 years). If 3 of 4 patients in either cohort of Part B do not achieve plasma RNA less than 1,000 copies/ml after 16 weeks of quadruple therapy, enrollment of patients to that cohort will stop and enrollment of 8 patients to the corresponding cohort in Part C will begin. For Part C, patients whose RNA level is no more than 1,000 copies/ml at Week 16 will remain on assigned treatment until Week 104. If at any time between Weeks 16 and 104 a patient's RNA level increases to greater than 1,000 copies/ml, plasma RNA will be repeated within 1 week. If both RNA levels are greater than 1,000 copies/ml, the patient will discontinue study treatment and be followed every 12 weeks for 1 year.] [AS PER AMENDMENT 4/14/99: The study has been extended for an additional 96 weeks for children with continued suppression of viral replication (RNA less than 400 copies/ml) at Week 104. If at any time between Week 12 or 16 and Week 200 a patient's RNA level increases to greater than 1,000 copies/ml, plasma RNA will be repeated within 1 week. If both RNA levels are above 1,000 copies/ml, the patient will discontinue treatment for best available therapy and be followed every 12 weeks for 1 year following the discontinuation of study treatment.] [AS PER AMENDMENT 9/16/99: An additional cohort (Cohort 7) of 5 to 10 patients has been added. Cohort 7 includes patients between 15 days and 3 months of age. Cohort 7 patients who experience suppression of viral replication at Week 104 are followed through Week 200.]"}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"2 years", "MinimumAge"=>"15 days", "StdAgeList"=>{"StdAge"=>["Child"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nChildren may be eligible for this study if they:\n\nAre 15 days to 2 years old.\nHave consent of parent or legal guardian.\nAre HIV-positive.\n\nExclusion Criteria\n\nChildren will not be eligible for this study if they:\n\nHave certain infections which require treatment during the study.\nHave received certain medications."}, "IdentificationModule"=>{"NCTId"=>"NCT00000872", "BriefTitle"=>"Treatment With Combinations of Several Antiviral Drugs in Infants and Young Children With HIV Infection", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"Early Intensive Antiretroviral Combination Therapy in HIV-1 Infected Infants and Children", "OrgStudyIdInfo"=>{"OrgStudyId"=>"ACTG 356"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"10605", "SecondaryIdType"=>"Registry Identifier", "SecondaryIdDomain"=>"DAIDS ES"}, {"SecondaryId"=>"PACTG 356"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Abacavir sulfate", "InterventionType"=>"Drug"}, {"InterventionName"=>"Nelfinavir mesylate", "InterventionType"=>"Drug"}, {"InterventionName"=>"Nevirapine", "InterventionType"=>"Drug"}, {"InterventionName"=>"Lamivudine", "InterventionType"=>"Drug"}, {"InterventionName"=>"Stavudine", "InterventionType"=>"Drug"}, {"InterventionName"=>"Zidovudine", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"32209", "LocationCity"=>"Gainesville", "LocationState"=>"Florida", "LocationCountry"=>"United States", "LocationFacility"=>"Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy"}, {"LocationZip"=>"701122699", "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"=>"212874933", "LocationCity"=>"Baltimore", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"Johns Hopkins Hosp. & Health System - Dept. of Peds., 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"=>"016550001", "LocationCity"=>"Worcester", "LocationState"=>"Massachusetts", "LocationCountry"=>"United States", "LocationFacility"=>"WNE Maternal Pediatric Adolescent AIDS CRS"}, {"LocationCity"=>"Detroit", "LocationState"=>"Michigan", "LocationCountry"=>"United States", "LocationFacility"=>"Univ. of Mississippi Med. Ctr Children's Hosp."}, {"LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Nyu Ny Nichd Crs"}, {"LocationZip"=>"191044318", "LocationCity"=>"Philadelphia", "LocationState"=>"Pennsylvania", "LocationCountry"=>"United States", "LocationFacility"=>"The Children's Hosp. of Philadelphia IMPAACT CRS"}, {"LocationZip"=>"77030", "LocationCity"=>"Houston", "LocationState"=>"Texas", "LocationCountry"=>"United States", "LocationFacility"=>"Texas Children's Hosp. CRS"}, {"LocationZip"=>"23507", "LocationCity"=>"Norfolk", "LocationState"=>"Virginia", "LocationCountry"=>"United States", "LocationFacility"=>"Children's Hosp. of the King's Daughters, Infectious Disease"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Katherine Luzuriaga", "OverallOfficialRole"=>"Study Chair"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)", "CollaboratorClass"=>"NIH"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
