Nctid:
NCT00000634
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000015658", "term"=>"HIV Infections"}], "ancestors"=>[{"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D000003141", "term"=>"Communicable Diseases"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000015229", "term"=>"Sexually Transmitted Diseases, Viral"}, {"id"=>"D000012749", "term"=>"Sexually Transmitted Diseases"}, {"id"=>"D000016180", "term"=>"Lentivirus Infections"}, {"id"=>"D000012192", "term"=>"Retroviridae Infections"}, {"id"=>"D000012327", "term"=>"RNA Virus Infections"}, {"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000007153", "term"=>"Immunologic Deficiency Syndromes"}, {"id"=>"D000007154", "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"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency 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"}], "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"=>"D000019829", "term"=>"Nevirapine"}], "ancestors"=>[{"id"=>"D000018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D000019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000000998", "term"=>"Antiviral Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000019380", "term"=>"Anti-HIV Agents"}, {"id"=>"D000044966", "term"=>"Anti-Retroviral Agents"}, {"id"=>"D000065701", "term"=>"Cytochrome P-450 CYP3A Inducers"}, {"id"=>"D000065693", "term"=>"Cytochrome P-450 Enzyme Inducers"}], "browseLeaves"=>[{"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M21717", "name"=>"Nevirapine", "asFound"=>"Bladder Cancer", "relevance"=>"HIGH"}, {"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"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>6}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2011-02", "lastUpdateSubmitDate"=>"2011-02-25", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2011-03-01", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"1995-06", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["Benzodiazepines", "Drug Evaluation", "Drugs, Investigational", "Acquired Immunodeficiency Syndrome", "Antiviral Agents"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"8843207", "type"=>"BACKGROUND", "citation"=>"Luzuriaga K, Bryson Y, McSherry G, Robinson J, Stechenberg B, Scott G, Lamson M, Cort S, Sullivan JL. Pharmacokinetics, safety, and activity of nevirapine in human immunodeficiency virus type 1-infected children. J Infect Dis. 1996 Oct;174(4):713-21. doi: 10.1093/infdis/174.4.713."}]}, "descriptionModule"=>{"briefSummary"=>"To generate initial information on the pharmacokinetics (blood levels) and dose proportionality of nevirapine (BI-RG-587) plasma levels in HIV-infected children; to assess the safety and tolerance of single rising oral doses of nevirapine in HIV-infected children; and to confirm that the single doses that achieve certain plasma levels in adults achieve similar levels in HIV-infected children.\n\nTest tube studies have shown that nevirapine (BI-RG-587) inhibits replication (reproduction) of HIV. Nevirapine works with zidovudine (AZT) and is active against strains of the virus that are resistant to AZT. Studies of the drug in HIV-infected adults showed no serious adverse effects.", "detailedDescription"=>"Test tube studies have shown that nevirapine (BI-RG-587) inhibits replication (reproduction) of HIV. Nevirapine works with zidovudine (AZT) and is active against strains of the virus that are resistant to AZT. Studies of the drug in HIV-infected adults showed no serious adverse effects.\n\nTwo doses, given by mouth, are evaluated: Three patients receive the lower dose, and 7 days after the third patient receives the lower dose, three additional patients receive the higher dose. After dosing, blood is drawn at 1, 2, 4, 8, 24, 48, 96, 168 hours to measure blood levels of the drug."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"13 years", "minimumAge"=>"2 months", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Intravenous gammaglobulin. Pneumocystis prophylaxis according to published guidelines.\n\nPatients must have the following:\n\n* HIV infection.\n* Parent or guardian must be available to give written informed consent.\n\nExclusion Criteria\n\nConcurrent Medication:\n\nExcluded:\n\n* Zidovudine (AZT).\n* Steroid dependency.\n\nExcluded within 1 hour before and 4 hours after study drug administration:\n\n* Drugs that might interfere with the absorption of study drug (H2 blockers, antacids, carafate, cholestyramine).\n* Benzodiazepines.\n* Alcohol-containing substances.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Requiring supplemental oxygen.\n\nPatients with the following are excluded:\n\n* Active opportunistic or serious bacterial infection.\n* Lymphoid interstitial pneumonitis (LIP) and steroid dependent or requiring supplemental oxygen or have a pretreatment pa02 \\< 70 mm Hg.\n* Pre-existing malignancies.\n\nPrior Medication:\n\nExcluded:\n\n* Zidovudine (AZT) within 7 days prior to administration of study drug.\n\nExcluded for at least 4 weeks prior to drug administration:\n\n* Other approved or investigational antiretroviral agents. All other investigational agents. Biologic response modifiers (e.g., interferon) or immunomodulators. Immunosuppressive agents (including glucocorticoids). Coumadin and other anticoagulant medications.\n\nPrior Treatment:\n\nExcluded:\n\n* Red blood cell transfusion within 4 weeks of study entry.\n\nPatients may not have the following:\n\n* Opportunistic or serious bacterial infection.\n\nZidovudine (AZT) \\> 7 days prior to administration of study drug.\n\nActive alcohol or drug abuse."}, "identificationModule"=>{"nctId"=>"NCT00000634", "briefTitle"=>"A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children", "orgStudyIdInfo"=>{"id"=>"ACTG 165"}, "secondaryIdInfos"=>[{"id"=>"00853"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Nevirapine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"01605", "city"=>"Worcester", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Univ of Massachusetts Med Ctr / Biotech II", "geoPoint"=>{"lat"=>42.26259, "lon"=>-71.80229}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Boehringer Ingelheim", "class"=>"INDUSTRY"}]}}}