Nctid:
NCT00002044
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D015658", "term"=>"HIV Infections"}, {"id"=>"D000163", "term"=>"Acquired Immunodeficiency Syndrome"}, {"id"=>"D015526", "term"=>"AIDS Dementia Complex"}, {"id"=>"D003704", "term"=>"Dementia"}, {"id"=>"D009468", "term"=>"Neuromuscular Diseases"}, {"id"=>"D007153", "term"=>"Immunologic Deficiency Syndromes"}], "ancestors"=>[{"id"=>"D001927", "term"=>"Brain Diseases"}, {"id"=>"D002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D019965", "term"=>"Neurocognitive Disorders"}, {"id"=>"D001523", "term"=>"Mental Disorders"}, {"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"=>"D007154", "term"=>"Immune System Diseases"}, {"id"=>"D012897", "term"=>"Slow Virus Diseases"}], "browseLeaves"=>[{"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M6904", "name"=>"Dementia", "asFound"=>"Dementia", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "asFound"=>"Human Immunodeficiency Virus (HIV)", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"Human Immunodeficiency Virus (HIV)", "relevance"=>"HIGH"}, {"id"=>"M12411", "name"=>"Neuromuscular Diseases", "asFound"=>"Neuromuscular Diseases", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "asFound"=>"Immunodeficiency", "relevance"=>"HIGH"}, {"id"=>"M18170", "name"=>"AIDS Dementia Complex", "asFound"=>"AIDS Dementia Complex", "relevance"=>"HIGH"}, {"id"=>"M3735", "name"=>"AIDS-Related Complex", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M21836", "name"=>"Neurocognitive Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "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"=>"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"}, {"id"=>"T247", "name"=>"AIDS Dementia Complex", "asFound"=>"AIDS Dementia Complex", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D015215", "term"=>"Zidovudine"}], "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"=>"M17920", "name"=>"Zidovudine", "asFound"=>"Corticosteroid", "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"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1995-02", "lastUpdateSubmitDate"=>"2005-06-23", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2005-06-24", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Pilot Projects", "Neuromuscular Diseases", "Drug Evaluation", "Acquired Immunodeficiency Syndrome", "AIDS Dementia Complex", "AIDS-Related Complex", "Zidovudine"], "conditions"=>["AIDS Dementia Complex", "Neuromuscular Diseases", "HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this pilot study is to evaluate the efficacy of Retrovir (AZT) in the treatment of AIDS-related dementia and various neuromuscular complications. HIV is both a lymphotropic and neurotropic virus which can affect both the central and peripheral nervous systems (CNS, PNS). There is evidence that the CNS and PNS may harbor the virus in a latent state, with the potential for continuous reinfection of other body systems. Therefore, effective therapeutic efforts against HIV infection should provide effective antiviral activity within the nervous system."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"70 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* Past or present renal disease.\n* Significant bone marrow suppression.\n* Blood transfusion within the past month.\n* Liver dysfunction.\n* Evidence of an underlying, severe infection.\n* Evidence of an active life-threatening opportunistic infection at study entry.\n* Severe malabsorption (patients with recent significant weight loss must have a serum carotene level of \\> 75 IU/ml).\n* Evidence of nervous system dysfunction being caused by factors other than HIV infection, particularly by cerebral toxoplasmosis, lymphoma, cryptococcal meningitis, chronic alcohol abuse, lead poisoning, cytomegalovirus (CMV) infection (patients with retinal CMV infection or other evidence of CMV dementia), syphilis, or progressive multifocal leukoencephalopathy.\n* Other known causes of nerve or muscle disease.\n* Hypersensitivity to zidovudine (AZT).\n* Lymphoma or other tumor requiring cytotoxic chemotherapy.\n\nConcurrent Treatment:\n\nAllowed:\n\n* Electron beam therapy to an area of less than 100 cm2.\n\nPatients with the following are excluded:\n\n* Past or present renal disease.\n* Significant bone marrow suppression.\n* Blood transfusion within the past month.\n* Liver dysfunction.\n* Evidence of an underlying, severe infection.\n* Evidence of an active life-threatening opportunistic infection at study entry.\n* Severe malabsorption (patients with recent significant weight loss must have a serum carotene level of \\> 75 IU/ml).\n* Evidence of nervous system dysfunction being caused by factors other than HIV infection, particularly by cerebral toxoplasmosis, lymphoma, cryptococcal meningitis, chronic alcohol abuse, lead poisoning, cytomegalovirus (CMV) infection (patients with retinal CMV infection or other evidence of CMV dementia), syphilis, or progressive multifocal leukoencephalopathy.\n* Other known causes of nerve or muscle disease.\n* Hypersensitivity to zidovudine (AZT).\n* Lymphoma or other tumor requiring cytotoxic chemotherapy.\n\nPatients with AIDS (CDC surveillance definition) or AIDS related complex (ARC).\n\n* All patients must have either:\n* Dementia as defined by a progressive cognitive impairment in the absence of altered consciousness that is thought to be causally related to HIV infection. Patients in this study will fall into the lower 20 percent (or less) of a normal sample of formal neuropsychological testing.\n* OR\n* One of the following neuromuscular diseases thought to be related to HIV infection:\n* Demyelinating polyneuropathy, axonal polyneuropathy, inflammatory myopathy, or unexplained progressive muscle weakness.\n* Capacity to give informed consent or a person with durable power of attorney who can give informed consent.\n* Life expectancy = or \\> 4 months.\n\nExclusion Criteria\n\nConcurrent Medication:\n\nExcluded:\n\n* Cytotoxic chemotherapy.\n* Steroids.\n* Interferon.\n* Immunomodulating agents.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Radiation therapy (except electron beam therapy to an area of less than 100 cm2).\n\nPrior Medication:\n\nExcluded within 4 weeks of study entry:\n\n* Cytotoxic chemotherapy.\n* Any retroviral drug including but not limited to zidovudine (AZT), ribavirin, HPA 23, AL721, or phosphonoformate.\n* Steroids.\n* Interferon.\n* Immunomodulating agents.\n* An anticipated need for any of these agents within the next 16 weeks.\n\nPrior Treatment:\n\nExcluded within 1 month of study entry:\n\n* Radiation therapy (except electron beam therapy to an area of less than 100 cm2).\n* Blood transfusion."}, "identificationModule"=>{"nctId"=>"NCT00002044", "briefTitle"=>"A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases", "orgStudyIdInfo"=>{"id"=>"014D"}, "secondaryIdInfos"=>[{"id"=>"14"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Zidovudine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"27709", "city"=>"Research Triangle Park", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Glaxo Wellcome Inc", "geoPoint"=>{"lat"=>35.90567, "lon"=>-78.90497}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Glaxo Wellcome", "class"=>"INDUSTRY"}}}}
