Nctid:
NCT00000761
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D015658", "term"=>"HIV Infections"}], "ancestors"=>[{"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D007239", "term"=>"Infections"}, {"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"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M3735", "name"=>"AIDS-Related Complex", "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"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D007372", "term"=>"Interferons"}, {"id"=>"D007371", "term"=>"Interferon-gamma"}], "ancestors"=>[{"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}], "browseLeaves"=>[{"id"=>"M10407", "name"=>"Interferons", "asFound"=>"Duration", "relevance"=>"HIGH"}, {"id"=>"M10406", "name"=>"Interferon-gamma", "asFound"=>"Phenylephrine", "relevance"=>"HIGH"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>20}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1997-10", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-27", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-11-03", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Interferon-gamma, Recombinant", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Kline MW, Fletcher CV, Douglas SD, Fenton T, Shearer WT. Recombinant human interferon-gamma (rIFN-gamma) treatment of HIV-infected children. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:143 (abstract no 424)"}, {"pmid"=>"10225828", "type"=>"BACKGROUND", "citation"=>"Shearer WT, Kline MW, Abramson SL, Fenton T, Starr SE, Douglas SD. Recombinant human gamma interferon in human immunodeficiency virus-infected children: safety, CD4(+)-lymphocyte count, viral load, and neutrophil function (AIDS Clinical Trials Group Protocol 211). Clin Diagn Lab Immunol. 1999 May;6(3):311-5. doi: 10.1128/CDLI.6.3.311-315.1999."}]}, "descriptionModule"=>{"briefSummary"=>"PRIMARY: To determine the safety and toxicity of recombinant interferon gamma-1b ( rIFN-gamma ) in HIV-infected children receiving ongoing zidovudine ( AZT ) or didanosine ( ddI ) therapy. To document HIV-associated defects in neutrophil and/or monocyte function that are improved with rIFN-gamma.\n\nSECONDARY: To determine whether a change in CD4 cell count occurs and to assess virologic status and effects on AZT and ddI pharmacokinetics.\n\nIt is likely that infants and children severely immunocompromised by HIV infection would respond to immunomodulators that augment different portions of the host defense system. Interferon-gamma has been shown to benefit children with severely compromised nonspecific immunity and may thus be of benefit to those with HIV infection.", "detailedDescription"=>"It is likely that infants and children severely immunocompromised by HIV infection would respond to immunomodulators that augment different portions of the host defense system. Interferon-gamma has been shown to benefit children with severely compromised nonspecific immunity and may thus be of benefit to those with HIV infection.\n\nPatients are treated with subcutaneous rIFN-gamma 3 times a week for 24 weeks and are then followed for an additional 12 weeks."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"17 years", "minimumAge"=>"1 year", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nRequired:\n\n* AZT or ddI therapy.\n* PCP prophylaxis.\n\nAllowed:\n\n* Antipyretics.\n* Antiemetics.\n* Antihistamines.\n* Decongestants.\n* Skin creams and lotions.\n* Immunizations according to current recommendations.\n\nPatients must have:\n\n* Class P-2 symptomatic HIV infection.\n* Ongoing AZT or ddI therapy of 6 months or longer duration.\n\nExclusion Criteria\n\nConcurrent Medication:\n\nExcluded:\n\n* Antiretroviral therapy other than AZT or ddI.\n* Chemotherapy for active malignancy.\n* Amphotericin B for systemic fungal infections.\n\nPatients with the following prior conditions are excluded:\n\n* History of congestive heart failure or arrhythmias.\n* History of congenital heart disease.\n* History of seizure disorder requiring anticonvulsant medication. (NOTE:\n\nHistory of uncomplicated febrile seizures does not exclude.)\n\nPrior Medication:\n\nExcluded within 8 weeks prior to study entry:\n\n* Immunomodulators other than IVIG.\n\nPrior Treatment:\n\nExcluded:\n\n* Red blood cell transfusion within 4 weeks prior to study entry.\n\nRequired:\n\n* Ongoing AZT or ddI therapy of 6 weeks or longer duration.\n* Ongoing PCP prophylaxis for more than 6 weeks duration.\n\nOngoing alcohol or drug use."}, "identificationModule"=>{"nctId"=>"NCT00000761", "briefTitle"=>"Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children", "orgStudyIdInfo"=>{"id"=>"ACTG 211"}, "secondaryIdInfos"=>[{"id"=>"11188", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Interferon gamma-1b", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"191044318", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"The Children's Hosp. of Philadelphia IMPAACT CRS", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"77030", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Texas Children's Hosp. CRS", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}], "overallOfficials"=>[{"name"=>"WT Shearer", "role"=>"STUDY_CHAIR"}, {"name"=>"SL Abramson", "role"=>"STUDY_CHAIR"}, {"name"=>"MW Kline", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Genentech, Inc.", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
