Nctid:
NCT00000961
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D015658", "term"=>"HIV Infections"}, {"id"=>"D000163", "term"=>"Acquired Immunodeficiency Syndrome"}], "ancestors"=>[{"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D015229", "term"=>"Sexually Transmitted Diseases, Viral"}, {"id"=>"D012749", "term"=>"Sexually Transmitted Diseases"}, {"id"=>"D016180", "term"=>"Lentivirus Infections"}, {"id"=>"D012192", "term"=>"Retroviridae Infections"}, {"id"=>"D012327", "term"=>"RNA Virus Infections"}, {"id"=>"D014777", "term"=>"Virus Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D007153", "term"=>"Immunologic Deficiency Syndromes"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}, {"id"=>"D012897", "term"=>"Slow Virus Diseases"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M2593", "name"=>"Blood-Borne Infections", "relevance"=>"LOW"}, {"id"=>"M15558", "name"=>"Sexually Transmitted Diseases", "relevance"=>"LOW"}, {"id"=>"M17933", "name"=>"Sexually Transmitted Diseases, Viral", "relevance"=>"LOW"}, {"id"=>"M18640", "name"=>"Lentivirus Infections", "relevance"=>"LOW"}, {"id"=>"M15026", "name"=>"Retroviridae Infections", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M15149", "name"=>"RNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M15700", "name"=>"Slow Virus Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D015215", "term"=>"Zidovudine"}, {"id"=>"D007106", "term"=>"Immune Sera"}], "ancestors"=>[{"id"=>"D000963", "term"=>"Antimetabolites"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D019380", "term"=>"Anti-HIV Agents"}, {"id"=>"D044966", "term"=>"Anti-Retroviral Agents"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M4225", "name"=>"Antibodies", "relevance"=>"LOW"}, {"id"=>"M10184", "name"=>"Immunoglobulins", "relevance"=>"LOW"}, {"id"=>"M19117", "name"=>"Immunoglobulins, Intravenous", "relevance"=>"LOW"}, {"id"=>"M8836", "name"=>"gamma-Globulins", "relevance"=>"LOW"}, {"id"=>"M20191", "name"=>"Rho(D) Immune Globulin", "relevance"=>"LOW"}, {"id"=>"M10154", "name"=>"Immune Sera", "asFound"=>"Not confirmed", "relevance"=>"HIGH"}, {"id"=>"M17920", "name"=>"Zidovudine", "asFound"=>"Underwent", "relevance"=>"HIGH"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}, {"id"=>"M25428", "name"=>"Anti-Retroviral Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"count"=>112}}, "statusModule"=>{"overallStatus"=>"TERMINATED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "lastUpdateSubmitDate"=>"2021-10-28", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-11-04", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"1991-05", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["Drug Therapy, Combination", "Zidovudine"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"7935655", "type"=>"BACKGROUND", "citation"=>"Spector SA, Gelber RD, McGrath N, Wara D, Barzilai A, Abrams E, Bryson YJ, Dankner WM, Livingston RA, Connor EM. A controlled trial of intravenous immune globulin for the prevention of serious bacterial infections in children receiving zidovudine for advanced human immunodeficiency virus infection. Pediatric AIDS Clinical Trials Group. N Engl J Med. 1994 Nov 3;331(18):1181-7. doi: 10.1056/NEJM199411033311802."}]}, "descriptionModule"=>{"briefSummary"=>"To determine the safety and tolerance of hyperimmune anti-HIV intravenous immunoglobulin (HIVIG) and of zidovudine (AZT) in infants with established HIV infection; to get preliminary evidence for the effectiveness of this type of treatment in preventing the advance of disease in HIV infected infants. HIVIG may be an effective agent that either alone or in combination with AZT will prevent progression of clinical disease.", "detailedDescription"=>"HIVIG may be an effective agent that either alone or in combination with AZT will prevent progression of clinical disease.\n\nParticipants are randomized to receive either oral AZT or HIVIG. Patients may receive treatment for a maximum of 48 weeks. Patients are evaluated during treatment at weeks 2, 4, and every 4 weeks thereafter. Infants who are receiving HIVIG initially are treated with the appropriate age-adjusted dose of oral AZT in addition to HIVIG if they meet clinical disease progression criteria. All participants who have completed 48 weeks of treatment or who are discontinued from treatment are followed every 3 months for an additional 48 weeks. This follow-up may be conducted over the telephone."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"3 months", "minimumAge"=>"1 day", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Recommended:\n* Standard immunizations. Should repeat MMR 3 months after discontinuing study.\n* Benadryl and/or aspirin.\n* Pneumocystis carinii pneumonia prophylaxis.\n* Systemic ketoconazole and acyclovir, or oral nystatin for acute therapy.\n* Aerosol ribavirin for short-term treatment of RSV.\n\nConcurrent Treatment:\n\nAllowed:\n\n* Blood transfusion.\n\nPatients must have the following:\n\n* Parent or guardian available to give written informed consent.\n* Protocol requires prior Institutional Review Board (IRB) approval before any subject is entered into study.\n\nPrior Medication:\n\nAllowed:\n\n* Gammaglobulin, intravenous (IV) or intramuscular (IM).\n* Immunoglobulin, IV (IVIG).\n* Maternal antiretroviral treatment during pregnancy.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Symptomatic of any class P-2 symptoms (except lymphadenopathy at time of study entry.\n* Presence of serious acute infection requiring parenteral treatment at time of study entry.\n\nConcurrent Medication:\n\nExcluded:\n\n* Prophylaxis for oral candidiasis or otitis media or other infections.\n* Immunoglobulin therapy (except single dose or for hypogammaglobulinemia).\n* Ketoconazole, acyclovir, or nystatin for prophylaxis.\n\nPatients with the following are excluded:\n\n* Symptomatic of any class P-2 symptoms (except lymphadenopathy at time of study entry.\n* Presence of serious acute infection requiring parenteral treatment at time of study entry.\n\nPrior Medication:\n\nExcluded:\n\n* Antiretroviral treatment or experimental treatment within 2 weeks of entry."}, "identificationModule"=>{"nctId"=>"NCT00000961", "briefTitle"=>"The Safety and Effectiveness of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HVIG) Plus Zidovudine in HIV-Infected Infants", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Phase II Study to Evaluate the Safety, Tolerance and Efficacy of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HIVIG) and of Zidovudine (ZDV) in Infants With Documented HIV Infections", "orgStudyIdInfo"=>{"id"=>"ACTG 131"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Anti-HIV Immune Serum Globulin (Human)", "type"=>"DRUG"}, {"name"=>"Zidovudine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"overallOfficials"=>[{"name"=>"Connor E", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Abbott", "class"=>"INDUSTRY"}, {"name"=>"Glaxo Wellcome", "class"=>"INDUSTRY"}]}}}
