Nctid:
NCT00002287
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D015658", "term"=>"HIV Infections"}, {"id"=>"D000163", "term"=>"Acquired Immunodeficiency Syndrome"}], "ancestors"=>[{"id"=>"D020969", "term"=>"Disease Attributes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D000086982", "term"=>"Blood-Borne 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"}, {"id"=>"D012897", "term"=>"Slow Virus Diseases"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "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"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "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"=>"1989-08", "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"=>["Health Manpower", "Accidents, Occupational", "Zidovudine"], "conditions"=>["HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"To evaluate the safety and effectiveness of Retrovir (AZT) when used as prophylaxis for health care workers at risk for HIV infection from exposure to HIV-contaminated blood or blood components."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"13 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Exclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* A prior history of a malignancy other than cutaneous basal cell or cervical carcinomas.\n* Other significant, chronic underlying medical illness which, in the physician's judgment, would impair study completion.\n* Evidence of compromised bone marrow function (lab results) with a blood transfusion within the last month.\n* Liver dysfunction as indicated by lab results.\n\nPatients are excluded if there is a prior diagnosis of HIV infection by one of the following criteria:\n\n* HIV antibody positive by ELISA and Western blot assays or by other certified test method. (Patients who are ELISA positive but Western blot or other confirmatory tests are negative may continue in study).\n* HIV antigen positive.\n* Clinical symptoms which lead to a diagnosis by a licensed physician of AIDS or AIDS related complex or AIDS-related dementia. Also excluded are individuals who have experienced similar HIV exposure as described in this protocol in the past month and individuals who have previously been enrolled in this study. The purpose of these exclusions is to eliminate possible seroconversion in an individual that could be attributed to HIV exposure other than the single exposure experienced just prior to entry into the study.\n\nPrior Medication:\n\nExcluded within 4 weeks of study entry:\n\n* Any potentially myelosuppressive drug.\n* Nephrotoxic agent.\n* Other experimental therapy.\n\nExposure of a health care worker to HIV-contaminated blood or blood component within 5 days prior to beginning therapy, defined as one of the following:\n\n* Penetrating wound from needle recently removed from patient or sample container (e.g., blood bag, blood tube) or from sharp object visibly contaminated with HIV-positive blood or blood component. In the case of needlesticks or cuts with sharp objects, blood or blood component must not have been exposed to the air for more than 1 hour. If actual infusion of blood occurs, the 1-hour time limit does not apply.\n* Hypodermic needles should come in contact with the blood and blood component from an HIV source but need not be visibly contaminated with blood to be considered a source of contamination.\n* Significant exposure to HIV-positive blood or blood component as the result of splash on abraded skin.\n* Significant exposure to HIV-positive blood or blood component as the result of splash on mucous membranes.\n* Participant must be able to give informed consent.\n\nActive drug or alcohol abuse sufficient in the physician's opinion to prevent compliance with the study regimen."}, "identificationModule"=>{"nctId"=>"NCT00002287", "briefTitle"=>"A Study of Retrovir in the Prevention of HIV Infection in Health Care Workers Accidentally Exposed to the Virus", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Placebo-Controlled Trial to Evaluate Retrovir in Preventing Infection With the Human Immunodeficiency Virus (HIV) in Health Care Workers After Accidental Exposure", "orgStudyIdInfo"=>{"id"=>"014I"}, "secondaryIdInfos"=>[{"id"=>"20"}]}, "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"}}}}
