Nctid:
NCT00000955
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D015658", "term"=>"HIV Infections"}, {"id"=>"D014376", "term"=>"Tuberculosis"}, {"id"=>"D000163", "term"=>"Acquired Immunodeficiency Syndrome"}, {"id"=>"D007153", "term"=>"Immunologic Deficiency Syndromes"}], "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"=>"D007154", "term"=>"Immune System Diseases"}, {"id"=>"D009164", "term"=>"Mycobacterium Infections"}, {"id"=>"D000193", "term"=>"Actinomycetales Infections"}, {"id"=>"D016908", "term"=>"Gram-Positive Bacterial Infections"}, {"id"=>"D001424", "term"=>"Bacterial Infections"}, {"id"=>"D001423", "term"=>"Bacterial Infections and Mycoses"}, {"id"=>"D012897", "term"=>"Slow Virus Diseases"}], "browseLeaves"=>[{"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M10018", "name"=>"Hypersensitivity", "relevance"=>"LOW"}, {"id"=>"M17127", "name"=>"Tuberculosis", "asFound"=>"Tuberculosis", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "asFound"=>"Human Immunodeficiency Virus (HIV) Infection", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"Human Immunodeficiency Virus (HIV) Infection", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "asFound"=>"Immunodeficiency", "relevance"=>"HIGH"}, {"id"=>"M12825", "name"=>"Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M19410", "name"=>"AIDS-Related Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M10019", "name"=>"Hypersensitivity, Delayed", "relevance"=>"LOW"}, {"id"=>"M3735", "name"=>"AIDS-Related Complex", "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"=>"M12119", "name"=>"Mycobacterium Infections", "relevance"=>"LOW"}, {"id"=>"M4722", "name"=>"Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M19252", "name"=>"Gram-Positive Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M12136", "name"=>"Mycoses", "relevance"=>"LOW"}, {"id"=>"M4721", "name"=>"Bacterial Infections and Mycoses", "relevance"=>"LOW"}, {"id"=>"M15700", "name"=>"Slow Virus Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"SCREENING", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>864}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2013-09", "completionDateStruct"=>{"date"=>"1992-12", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2013-09-28", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2013-10-01", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"1992-12", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"To estimate the percentage of HIV-infected individuals who demonstrate the booster effect", "timeFrame"=>"Throughout study"}], "secondaryOutcomes"=>[{"measure"=>"To determine the relationships among the booster effect, CD4+ cell count, and other HIV-related patient characteristics", "timeFrame"=>"Throughout study"}, {"measure"=>"To determine the relationship of boosting to CD4+ cell counts, HIV exposure categories, demographics, and TB risk categories", "timeFrame"=>"Throughout study"}, {"measure"=>"To determine the relationship of induration size after the first PPD skin test to that after the second PPD skin test", "timeFrame"=>"After the second PPD skin test"}]}, "conditionsModule"=>{"keywords"=>["Tuberculosis", "Immunologic Tests", "Tuberculin", "Tuberculin Test", "AIDS-Related Opportunistic Infections", "Injections, Intradermal", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex", "Hypersensitivity, Delayed"], "conditions"=>["HIV Infections", "Tuberculosis"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Thompson C, Gordin F, Muth K, Daniels K, Matts J, Maiatico G, Deyton L. Two stage tuberculin (PPD) skin testing in individuals with HIV infection. Int Conf AIDS. 1992 Jul 19-24;8(3):140 (abstract no PuB 7546)"}, {"pmid"=>"7881675", "type"=>"BACKGROUND", "citation"=>"Webster CT, Gordin FM, Matts JP, Korvick JA, Miller C, Muth K, Brown LS, Besch CL, Kumi JO, Salveson C, et al. Two-stage tuberculin skin testing in individuals with human immunodeficiency virus infection. Community Programs for Clinical Research on AIDS. Am J Respir Crit Care Med. 1995 Mar;151(3 Pt 1):805-8. doi: 10.1164/ajrccm.151.3.7881675."}]}, "descriptionModule"=>{"briefSummary"=>"To quantitate in an HIV-infected population the percentage of patients demonstrating the \"booster\" phenomenon (attainment of a positive response to a second tuberculin purified protein derivative skin test when the first skin test was negative); to determine the relationship between the booster phenomenon and CD4-positive lymphocyte cell counts; to detect any relationship between the booster phenomenon and HIV exposure category.\n\nThe accuracy of skin testing to detect Mycobacterium tuberculosis (MTb) infection is dependent upon the host's ability to mount a delayed-type hypersensitivity (DTH) reaction; however, the DTH response may be impaired or absent in patients with impaired cell-mediated immunity, a classic characteristic of HIV infection. Patients in whom immunity is diminished, but not absent, may test negative the first time a purified protein derivative skin test for MTb is administered, but if the same skin test is repeated, a positive DTH response may then be elicited. This occurrence is known as the \"booster\" phenomenon.", "detailedDescription"=>"The accuracy of skin testing to detect Mycobacterium tuberculosis (MTb) infection is dependent upon the host's ability to mount a delayed-type hypersensitivity (DTH) reaction; however, the DTH response may be impaired or absent in patients with impaired cell-mediated immunity, a classic characteristic of HIV infection. Patients in whom immunity is diminished, but not absent, may test negative the first time a purified protein derivative skin test for MTb is administered, but if the same skin test is repeated, a positive DTH response may then be elicited. This occurrence is known as the \"booster\" phenomenon.\n\nPatients who have had a negative purified protein derivative (PPD) skin test for M. tuberculosis within 7-28 days prior to study entry will receive a second PPD test by the Mantoux method (5 TU intradermally to the volar aspect of the forearm). Skin tests will be read 48-72 hours after application. Patients with a positive skin test (defined as an induration, or small hard knot, of 5 mm or greater forming beneath the skin) will be referred to their primary physicians for further evaluation."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"13 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have:\n\n* HIV infection.\n* Negative PPD skin test within previous 7-28 days.\n\nExclusion Criteria\n\nConcurrent Medication:\n\nExcluded:\n\n* Steroids.\n* Live viral vaccines.\n* Antihistamines.\n* Chemoprophylaxis or chemotherapy for suspected or confirmed tuberculosis.\n\nPatients with the following prior conditions are excluded:\n\n* History of documented positive PPD skin test.\n* History of tuberculosis or who are presently receiving chemoprophylaxis or chemotherapy for suspected or confirmed tuberculosis.\n* History of sensitivity to tuberculin or components of PPD.\n\nPrior Medication:\n\nExcluded:\n\n* Live viral vaccine within the past 4 weeks.\n* Steroid therapy within the past 4 weeks.\n* Antihistamines within the past week.\n* Chemoprophylaxis or chemotherapy for suspected or confirmed tuberculosis."}, "identificationModule"=>{"nctId"=>"NCT00000955", "briefTitle"=>"Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection", "orgStudyIdInfo"=>{"id"=>"CPCRA 008"}, "secondaryIdInfos"=>[{"id"=>"11560", "type"=>"REGISTRY", "domain"=>"DAIDS ES"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"OTHER", "label"=>"A", "description"=>"All eligible study participants", "interventionNames"=>["Drug: Tuberculin Purified Protein Derivative"]}], "interventions"=>[{"name"=>"Tuberculin Purified Protein Derivative", "type"=>"DRUG", "description"=>"Administered intradermally at 5 TU per 0.1 mL", "armGroupLabels"=>["A"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"06519", "city"=>"New Haven", "state"=>"Connecticut", "country"=>"United States", "facility"=>"Hill Health Corp", "geoPoint"=>{"lat"=>41.30815, "lon"=>-72.92816}}, {"zip"=>"19899", "city"=>"Wilmington", "state"=>"Delaware", "country"=>"United States", "facility"=>"Wilmington Hosp / Med Ctr of Delaware", "geoPoint"=>{"lat"=>39.74595, "lon"=>-75.54659}}, {"zip"=>"20422", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Veterans Administration Med Ctr / Regional AIDS Program", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"60657", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"AIDS Research Alliance - Chicago", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"70112", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Louisiana Comm AIDS Rsch Prog / Tulane Univ Med", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"48201", "city"=>"Detroit", "state"=>"Michigan", "country"=>"United States", "facility"=>"Comprehensive AIDS Alliance of Detroit", "geoPoint"=>{"lat"=>42.33143, "lon"=>-83.04575}}, {"zip"=>"48202", "city"=>"Detroit", "state"=>"Michigan", "country"=>"United States", "facility"=>"Henry Ford Hosp", "geoPoint"=>{"lat"=>42.33143, "lon"=>-83.04575}}, {"zip"=>"07103", "city"=>"Newark", "state"=>"New Jersey", "country"=>"United States", "facility"=>"North Jersey Community Research Initiative", "geoPoint"=>{"lat"=>40.73566, "lon"=>-74.17237}}, {"zip"=>"10456", "city"=>"Bronx", "state"=>"New York", "country"=>"United States", "facility"=>"Bronx Lebanon Hosp Ctr", "geoPoint"=>{"lat"=>40.84985, "lon"=>-73.86641}}, {"zip"=>"11201", "city"=>"Brooklyn", "state"=>"New York", "country"=>"United States", "facility"=>"Addiction Research and Treatment Corp", "geoPoint"=>{"lat"=>40.6501, "lon"=>-73.94958}}, {"zip"=>"10011", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Clinical Directors Network of Region II", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10037", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Harlem AIDS Treatment Group / Harlem Hosp Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"97210", "city"=>"Portland", "state"=>"Oregon", "country"=>"United States", "facility"=>"Portland Veterans Adm Med Ctr / Rsch & Education Grp", "geoPoint"=>{"lat"=>45.52345, "lon"=>-122.67621}}, {"zip"=>"23298", "city"=>"Richmond", "state"=>"Virginia", "country"=>"United States", "facility"=>"Richmond AIDS Consortium", "geoPoint"=>{"lat"=>37.55376, "lon"=>-77.46026}}], "overallOfficials"=>[{"name"=>"Thompson C", "role"=>"STUDY_CHAIR"}, {"name"=>"Gordin F", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Warner Lambert - Parke Davis", "class"=>"INDUSTRY"}], "responsibleParty"=>{"oldNameTitle"=>"Rona Siskind", "oldOrganization"=>"DAIDS"}}}}
