Nctid:
NCT00000851
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "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"=>"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"=>"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"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System 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"=>"D016049", "term"=>"Didanosine"}, {"id"=>"D018119", "term"=>"Stavudine"}], "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"}], "browseLeaves"=>[{"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M17920", "name"=>"Zidovudine", "relevance"=>"LOW"}, {"id"=>"M20272", "name"=>"Stavudine", "asFound"=>"Twenty", "relevance"=>"HIGH"}, {"id"=>"M18548", "name"=>"Didanosine", "asFound"=>"Circulation", "relevance"=>"HIGH"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "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"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>198}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1998-10", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-27", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-11-04", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Didanosine", "Drug Therapy, Combination", "Antiviral Agents", "Stavudine"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"10224206", "type"=>"BACKGROUND", "citation"=>"Kline MW, Van Dyke RB, Lindsey JC, Gwynne M, Culnane M, Diaz C, Yogev R, McKinney RE Jr, Abrams EJ, Mofenson LM. Combination therapy with stavudine (d4T) plus didanosine (ddI) in children with human immunodeficiency virus infection. The Pediatric AIDS Clinical Trials Group 327 Team. Pediatrics. 1999 May;103(5):e62. doi: 10.1542/peds.103.5.e62."}, {"pmid"=>"21037891", "type"=>"BACKGROUND", "citation"=>"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."}]}, "descriptionModule"=>{"briefSummary"=>"To evaluate the safety and determine the pharmacokinetic disposition of stavudine (d4T) alone and in combination with didanosine (ddI), and whether concurrent administration alters the disposition of either drug. To compare d4T versus d4T plus ddI with respect to short and long term changes from baseline in plasma HIV RNA concentrations. To determine the relationship, if any, between drug exposure and viral burden.\n\nIn a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the three children with baseline counts greater than 50 cells/micro liter experienced a 20% increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the same regimen for children with less advanced HIV disease should be undertaken.", "detailedDescription"=>"In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the three children with baseline counts greater than 50 cells/micro liter experienced a 20% increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the same regimen for children with less advanced HIV disease should be undertaken.\n\nEligible subjects receiving d4T will be assigned in an open manner to Arm 1, and subjects who have been receiving zidovudine (AZT) will be assigned in a randomized, double blind manner to Arms 2 and 3. Each subject will receive study drug for 48 weeks as follows: Arm 1 - d4T plus ddI, Arm 2 - d4T alone, Arm 3 - d4T plus ddI."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"10 years", "minimumAge"=>"6 months", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must:\n\n* Be on-study, on-treatment in ACTG 240, or receiving AZT monotherapy by prescription for at least 6 months immediately preceding enrollment.\n* Have laboratory evidence of HIV-1 infection \\< 18 months - 2 positive viral tests \\>= 18 months - 2 positive viral tests or 2 or more positive tests for HIV antibody\n* Have parent or legal guardian willing to sign a consent.\n\nPrior Medication: Required:\n\n* On-study, on-treatment in ACTG 240 (D4T or AZT) or receiving AZT monotherapy by prescription for at least six months immediately preceding this trial.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with any of the following symptoms or conditions are excluded:\n\n* Intractable diarrhea or vomiting.\n* Current clinical or laboratory Grade 3 or worse toxicities.\n\nConcurrent Medication:\n\nExcluded:\n\n* Concurrent use of antiretroviral agents other than those provided by the study, immunomodulators (other than IVIG or corticosteroids), or other investigational drugs except for those in ACTG 254 and ACTG 219.\n* Chemotherapy for active malignancy.\n\nPatients with any of the following prior conditions are excluded:\n\n* Reached an ACTG 240 defined endpoint, or are permanently off ACTG 240 study treatment.\n* Prescription AZT recipients may not have received \\> 6 weeks of d4T or ddI previously.\n* Subjects who have had chemotherapy for active malignancy.\n\nPrior Medication:\n\nExcluded:\n\n* Prescription AZT recipients may not have received \\> 6 weeks of d4T or ddI previously."}, "identificationModule"=>{"nctId"=>"NCT00000851", "briefTitle"=>"Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"Trial of Stavudine (d4T) Plus Didanosine (ddI) in Children on Long-Term Stavudine Monotherapy, and Stavudine Versus Stavudine Plus Didanosine in Children on Long-Term Zidovudine Monotherapy: A Rollover Protocol for ACTG 240 Participants and Children Receiving Prescription Zidovudine", "orgStudyIdInfo"=>{"id"=>"ACTG 327"}, "secondaryIdInfos"=>[{"id"=>"11300", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Stavudine", "type"=>"DRUG"}, {"name"=>"Didanosine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90502", "city"=>"Torrance", "state"=>"California", "country"=>"United States", "facility"=>"Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases", "geoPoint"=>{"lat"=>33.83585, "lon"=>-118.34063}}, {"city"=>"Aurora", "state"=>"Colorado", "country"=>"United States", "facility"=>"Univ. of Colorado Denver NICHD CRS", "geoPoint"=>{"lat"=>39.72943, "lon"=>-104.83192}}, {"zip"=>"06032", "city"=>"Farmington", "state"=>"Connecticut", "country"=>"United States", "facility"=>"Univ. of Connecticut Health Ctr., Dept. of Ped.", "geoPoint"=>{"lat"=>41.71982, "lon"=>-72.83204}}, {"city"=>"Hartford", "state"=>"Connecticut", "country"=>"United States", "facility"=>"Connecticut Children's Med. Ctr.", "geoPoint"=>{"lat"=>41.76371, "lon"=>-72.68509}}, {"zip"=>"20010", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Children's National Med. Ctr., ACTU", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"20060", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Howard Univ. Washington DC NICHD CRS", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"32209", "city"=>"Jacksonville", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ. of Florida Jacksonville NICHD CRS", "geoPoint"=>{"lat"=>30.33218, "lon"=>-81.65565}}, {"zip"=>"33161", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ. of Miami Ped. Perinatal HIV/AIDS CRS", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Cook County Hosp.", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60614", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Chicago Children's CRS", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60637", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"70112", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Tulane/LSU Maternal/Child CRS", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"21201", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"02115", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"HMS - Children's Hosp. Boston, Div. of Infectious Diseases", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"48201", "city"=>"Detroit", "state"=>"Michigan", "country"=>"United States", "facility"=>"Children's Hospital of Michigan NICHD CRS", "geoPoint"=>{"lat"=>42.33143, "lon"=>-83.04575}}, {"zip"=>"08903", "city"=>"New Brunswick", "state"=>"New Jersey", "country"=>"United States", "facility"=>"UMDNJ - Robert Wood Johnson", "geoPoint"=>{"lat"=>40.48622, "lon"=>-74.45182}}, {"city"=>"Newark", "state"=>"New Jersey", "country"=>"United States", "facility"=>"NJ Med. School CRS", "geoPoint"=>{"lat"=>40.73566, "lon"=>-74.17237}}, {"zip"=>"10457", "city"=>"Bronx", "state"=>"New York", "country"=>"United States", "facility"=>"Bronx-Lebanon Hosp. IMPAACT CRS", "geoPoint"=>{"lat"=>40.84985, "lon"=>-73.86641}}, {"zip"=>"11203", "city"=>"Brooklyn", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS", "geoPoint"=>{"lat"=>40.6501, "lon"=>-73.94958}}, {"zip"=>"11021", "city"=>"Great Neck", "state"=>"New York", "country"=>"United States", "facility"=>"North Shore-Long Island Jewish Health System, Dept. of Peds.", "geoPoint"=>{"lat"=>40.80066, "lon"=>-73.72846}}, {"zip"=>"11040", "city"=>"New Hyde Park", "state"=>"New York", "country"=>"United States", "facility"=>"Schneider Children's Hosp., Div. of Infectious Diseases", "geoPoint"=>{"lat"=>40.7351, "lon"=>-73.68791}}, {"zip"=>"10029", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Metropolitan Hosp. NICHD CRS", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10032", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Columbia IMPAACT CRS", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10032", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Incarnation Children's Ctr.", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10037", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Harlem Hosp. Ctr. NY NICHD CRS", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"city"=>"Rochester", "state"=>"New York", "country"=>"United States", "facility"=>"Strong Memorial Hospital Rochester NY NICHD CRS", "geoPoint"=>{"lat"=>43.15478, "lon"=>-77.61556}}, {"city"=>"Stony Brook", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY Stony Brook NICHD CRS", "geoPoint"=>{"lat"=>40.92565, "lon"=>-73.14094}}, {"zip"=>"27710", "city"=>"Durham", "state"=>"North Carolina", "country"=>"United States", "facility"=>"DUMC Ped. CRS", "geoPoint"=>{"lat"=>35.99403, "lon"=>-78.89862}}, {"zip"=>"19134", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"St. Christopher's Hosp. for Children", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"29425", "city"=>"Charleston", "state"=>"South Carolina", "country"=>"United States", "facility"=>"Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases", "geoPoint"=>{"lat"=>32.77657, "lon"=>-79.93092}}, {"zip"=>"75235", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"Children's Med. Ctr. Dallas", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"77030", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Texas Children's Hosp. CRS", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"00956", "city"=>"Bayamon", "country"=>"Puerto Rico", "facility"=>"Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.", "geoPoint"=>{"lat"=>18.39856, "lon"=>-66.15572}}, {"zip"=>"00936", "city"=>"San Juan", "country"=>"Puerto Rico", "facility"=>"San Juan City Hosp. PR NICHD CRS", "geoPoint"=>{"lat"=>18.46633, "lon"=>-66.10572}}, {"zip"=>"00936", "city"=>"San Juan", "country"=>"Puerto Rico", "facility"=>"Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS", "geoPoint"=>{"lat"=>18.46633, "lon"=>-66.10572}}], "overallOfficials"=>[{"name"=>"Kline M", "role"=>"STUDY_CHAIR"}, {"name"=>"Van Dyke R", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
