Nctid:
NCT00000828
Payload:
{"FullStudy"=>{"Rank"=>474785, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000015658", "ConditionMeshTerm"=>"HIV Infections"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000086982", "ConditionAncestorTerm"=>"Blood-Borne Infections"}, {"ConditionAncestorId"=>"D000003141", "ConditionAncestorTerm"=>"Communicable Diseases"}, {"ConditionAncestorId"=>"D000007239", "ConditionAncestorTerm"=>"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"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M16045", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9973", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6058", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M13820", "ConditionBrowseLeafName"=>"Pregnancy Complications, Infectious", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17940", "ConditionBrowseLeafName"=>"HIV Infections", "ConditionBrowseLeafAsFound"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M13817", "ConditionBrowseLeafName"=>"Pregnancy Complications", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9889", "ConditionBrowseLeafName"=>"Immunologic Deficiency Syndromes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3212", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3425", "ConditionBrowseLeafName"=>"AIDS-Related Complex", "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"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}]}}, "InterventionBrowseModule"=>{"InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M17610", "InterventionBrowseLeafName"=>"Zidovudine", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"StudyType"=>"Observational", "EnrollmentInfo"=>{"EnrollmentCount"=>"250"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"October 1997", "LastUpdateSubmitDate"=>"June 23, 2005", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"August 30, 2001", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"June 24, 2005", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"August 31, 2001", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Pregnancy", "Pregnancy Complications, Infectious", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex", "Zidovudine", "Drug Resistance, Microbial", "Disease Transmission, Vertical"]}, "ConditionList"=>{"Condition"=>["HIV Infections", "Pregnancy"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"8734001", "ReferenceType"=>"background", "ReferenceCitation"=>"Bardeguez AD. Management of HIV infection for the childbearing age woman. Clin Obstet Gynecol. 1996 Jun;39(2):344-60. doi: 10.1097/00003081-199606000-00009. No abstract available."}, {"ReferenceType"=>"background", "ReferenceCitation"=>"Bardeguez AD, Taylor U, Appuzio J, Leus C, Lister M, Denny T, Palumbo P, Connor E. Characteristics of pregnant women infected with human immunodeficiency virus 1: Newark perinatal transmission study. Int Conf AIDS. 1991 Jun 16-21;7(2):193 (abstract no WB2044)"}, {"ReferenceType"=>"background", "ReferenceCitation"=>"Japour AJ, Welles S, McIntosh K, Colson A, Chung P, Lockman S, Davenny K, Fowler MG, Hansen IC, Kalish L, Moye J, Rick K, Zorilla C, Pitt J. ZDV resistance (ZDVR) mutations in ZDV exposed mother infant pairs: preliminary findings from the women and infants transmission study (WITS). Int Conf AIDS. 1996 Jul 7-12;11(1):370 (abstract no TuC2606)"}, {"ReferencePMID"=>"10432324", "ReferenceType"=>"background", "ReferenceCitation"=>"Garcia PM, Kalish LA, Pitt J, Minkoff H, Quinn TC, Burchett SK, Kornegay J, Jackson B, Moye J, Hanson C, Zorrilla C, Lew JF. Maternal levels of plasma human immunodeficiency virus type 1 RNA and the risk of perinatal transmission. Women and Infants Transmission Study Group. N Engl J Med. 1999 Aug 5;341(6):394-402. doi: 10.1056/NEJM199908053410602."}]}}, "DescriptionModule"=>{"BriefSummary"=>"To identify patterns of zidovudine ( AZT ) susceptibility among mother/infant pairs with perinatal HIV transmission.\n\nMost HIV-infected infants acquire their disease via perinatal transmission. Since transmission of HIV-resistant strains to infants could alter the course of disease and response to currently recommended treatment, a study to assess the patterns of AZT susceptibility among mother/infant pairs with perinatal transmission is essential to delineate future therapeutic strategies.", "DetailedDescription"=>"Most HIV-infected infants acquire their disease via perinatal transmission. Since transmission of HIV-resistant strains to infants could alter the course of disease and response to currently recommended treatment, a study to assess the patterns of AZT susceptibility among mother/infant pairs with perinatal transmission is essential to delineate future therapeutic strategies.\n\nHIV-infected pregnant women are enrolled at 20-36 weeks gestation. Patients have blood drawn for HIV culture at study entry and at delivery. Infants have blood drawn for HIV culture at delivery and at 1, 3, 6, and 18 months of age."}, "EligibilityModule"=>{"Gender"=>"Female", "MaximumAge"=>"60 years", "MinimumAge"=>"13 years", "StdAgeList"=>{"StdAge"=>["Child", "Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nPrior Medication: Required:\n\nAt least 6 months of prior AZT, including continuously during the current pregnancy.\n\nPatients must have:\n\nHIV seropositivity.\nCD4 count <= 300 cells/mm3.\nGestational age of 20-36 weeks, with intention to carry pregnancy to term.\nAt least 6 months of prior AZT therapy, including continuous AZT therapy during the current pregnancy.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\nEvidence of pre-existing fetal anomalies that would preclude survival to the end of the study, such as anencephaly, renal agenesis, or Potter's syndrome.\n\nConcurrent Medication:\n\nExcluded:\n\nAntiretrovirals other than AZT."}, "IdentificationModule"=>{"NCTId"=>"NCT00000828", "BriefTitle"=>"Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine", "OrgStudyIdInfo"=>{"OrgStudyId"=>"ACTG 255"}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"35294", "LocationCity"=>"Birmingham", "LocationState"=>"Alabama", "LocationCountry"=>"United States", "LocationFacility"=>"Univ of Alabama at Birmingham Schl of Med / Pediatrics"}, {"LocationZip"=>"920930672", "LocationCity"=>"La Jolla", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"UCSD Med Ctr / Pediatrics / Clinical Sciences"}, {"LocationZip"=>"90801", "LocationCity"=>"Long Beach", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Long Beach Memorial (Pediatric)"}, {"LocationZip"=>"90033", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Los Angeles County - USC Med Ctr"}, {"LocationZip"=>"900951752", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"UCLA Med Ctr / Pediatric"}, {"LocationZip"=>"905022004", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Harbor - UCLA Med Ctr / UCLA School of Medicine"}, {"LocationZip"=>"06032", "LocationCity"=>"Farmington", "LocationState"=>"Connecticut", "LocationCountry"=>"United States", "LocationFacility"=>"Univ of Connecticut / Farmington"}, {"LocationZip"=>"06106", "LocationCity"=>"Hartford", "LocationState"=>"Connecticut", "LocationCountry"=>"United States", "LocationFacility"=>"Connecticut Children's Med Ctr - Pediatric"}, {"LocationZip"=>"200102916", "LocationCity"=>"Washington", "LocationState"=>"District of Columbia", "LocationCountry"=>"United States", "LocationFacility"=>"Children's Hosp of Washington DC"}, {"LocationZip"=>"20060", "LocationCity"=>"Washington", "LocationState"=>"District of Columbia", "LocationCountry"=>"United States", "LocationFacility"=>"Howard Univ Hosp"}, {"LocationZip"=>"33161", "LocationCity"=>"Miami", "LocationState"=>"Florida", "LocationCountry"=>"United States", "LocationFacility"=>"Univ of Miami (Pediatric)"}, {"LocationZip"=>"606371470", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"Univ of Chicago Children's Hosp"}, {"LocationZip"=>"701122699", "LocationCity"=>"New Orleans", "LocationState"=>"Louisiana", "LocationCountry"=>"United States", "LocationFacility"=>"Tulane Univ / Charity Hosp of New Orleans"}, {"LocationZip"=>"70112", "LocationCity"=>"New Orleans", "LocationState"=>"Louisiana", "LocationCountry"=>"United States", "LocationFacility"=>"Univ Hosp"}, {"LocationZip"=>"212874933", "LocationCity"=>"Baltimore", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"Johns Hopkins Hosp - Pediatric"}, {"LocationZip"=>"021155724", "LocationCity"=>"Boston", "LocationState"=>"Massachusetts", "LocationCountry"=>"United States", "LocationFacility"=>"Children's Hosp of Boston"}, {"LocationZip"=>"02115", "LocationCity"=>"Boston", "LocationState"=>"Massachusetts", "LocationCountry"=>"United States", "LocationFacility"=>"Brigham and Women's Hosp"}, {"LocationZip"=>"01199", "LocationCity"=>"Springfield", "LocationState"=>"Massachusetts", "LocationCountry"=>"United States", "LocationFacility"=>"Baystate Med Ctr of Springfield"}, {"LocationZip"=>"071032714", "LocationCity"=>"Newark", "LocationState"=>"New Jersey", "LocationCountry"=>"United States", "LocationFacility"=>"Univ of Medicine & Dentistry of New Jersey / Univ Hosp"}, {"LocationZip"=>"10457", "LocationCity"=>"Bronx", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Bronx Lebanon Hosp Ctr"}, {"LocationZip"=>"10016", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Bellevue Hosp / New York Univ Med Ctr"}, {"LocationZip"=>"10029", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Mount Sinai Med Ctr / Pediatrics"}, {"LocationZip"=>"10032", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Columbia Presbyterian Med Ctr"}, {"LocationZip"=>"10032", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Incarnation Children's Ctr / Columbia Presbyterian Med Ctr"}, {"LocationZip"=>"14642", "LocationCity"=>"Rochester", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Univ of Rochester Medical Center"}, {"LocationZip"=>"13210", "LocationCity"=>"Syracuse", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"SUNY Health Sciences Ctr at Syracuse / Pediatrics"}, {"LocationZip"=>"277103499", "LocationCity"=>"Durham", "LocationState"=>"North Carolina", "LocationCountry"=>"United States", "LocationFacility"=>"Duke Univ Med Ctr"}, {"LocationZip"=>"432052696", "LocationCity"=>"Columbus", "LocationState"=>"Ohio", "LocationCountry"=>"United States", "LocationFacility"=>"Columbus Children's Hosp"}, {"LocationZip"=>"009367344", "LocationCity"=>"San Juan", "LocationCountry"=>"Puerto Rico", "LocationFacility"=>"San Juan City Hosp"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Bardeguez AD", "OverallOfficialRole"=>"Study Chair"}, {"OverallOfficialName"=>"Pitt J", "OverallOfficialRole"=>"Study Chair"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}}}}}}
