Nctid:
NCT00002106
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-11-01"}, "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"=>"D011899", "term"=>"Ranitidine"}, {"id"=>"C073340", "term"=>"Ranitidine bismuth citrate"}], "ancestors"=>[{"id"=>"D000897", "term"=>"Anti-Ulcer Agents"}, {"id"=>"D005765", "term"=>"Gastrointestinal Agents"}, {"id"=>"D006635", "term"=>"Histamine H2 Antagonists"}, {"id"=>"D006633", "term"=>"Histamine Antagonists"}, {"id"=>"D018494", "term"=>"Histamine Agents"}, {"id"=>"D018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M14745", "name"=>"Ranitidine", "asFound"=>"Secondary outcome measures", "relevance"=>"HIGH"}, {"id"=>"M252088", "name"=>"Ranitidine bismuth citrate", "asFound"=>"Secondary outcome measures", "relevance"=>"HIGH"}, {"id"=>"M21320", "name"=>"Citric Acid", "relevance"=>"LOW"}, {"id"=>"M1837", "name"=>"Sodium Citrate", "relevance"=>"LOW"}, {"id"=>"M5011", "name"=>"Bismuth", "relevance"=>"LOW"}, {"id"=>"M226511", "name"=>"Bismuth tripotassium dicitrate", "relevance"=>"LOW"}, {"id"=>"M4188", "name"=>"Antacids", "relevance"=>"LOW"}, {"id"=>"M4219", "name"=>"Anti-Ulcer Agents", "relevance"=>"LOW"}, {"id"=>"M8881", "name"=>"Gastrointestinal Agents", "relevance"=>"LOW"}, {"id"=>"M9708", "name"=>"Histamine", "relevance"=>"LOW"}, {"id"=>"M9711", "name"=>"Histamine H2 Antagonists", "relevance"=>"LOW"}, {"id"=>"M212144", "name"=>"Histamine phosphate", "relevance"=>"LOW"}, {"id"=>"M9709", "name"=>"Histamine Antagonists", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}, {"id"=>"T382", "name"=>"Citrate", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anticoagulants", "abbrev"=>"AnCoag"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"count"=>104}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1994-05", "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"=>["Ranitidine"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Bartlett JA, Berry PS, Bockmon KW, Stein A, Johnson J, Quinn JB, Weinhold KJ. A placebo controlled trial of ranitidine in HIV infection. Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:149"}]}, "descriptionModule"=>{"briefSummary"=>"To evaluate the effect of ranitidine on immunologic indicators in asymptomatic HIV-1 infected patients with CD4 counts of 400-700 cells/mm3.", "detailedDescription"=>"Patients are randomized to receive either ranitidine or matching placebo bid for 16 weeks, with follow-up every 4 weeks through week 20."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have:\n\n* Asymptomatic HIV-1 infection.\n* CD4 count of 400-700 cells/mm3.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Significant illness.\n* Acute illness at randomization.\n* Hemodialysis.\n\nPrior Medication:\n\nExcluded:\n\n* Antiretroviral use within 60 days prior to study entry."}, "identificationModule"=>{"nctId"=>"NCT00002106", "briefTitle"=>"A Pilot Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multicenter Trial to Evaluate the Effect of Ranitidine on Immunologic Indicators in Asymptomatic HIV-1 Infected Subjects With a CD4 Cell Count Between 400-700 Cells/mm3", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Pilot Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multicenter Trial to Evaluate the Effect of Ranitidine on Immunologic Indicators in Asymptomatic HIV-1 Infected Subjects With a CD4 Cell Count Between 400-700 Cells/mm3", "orgStudyIdInfo"=>{"id"=>"135A"}, "secondaryIdInfos"=>[{"id"=>"RAN-809"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Ranitidine hydrochloride", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"91403", "city"=>"Sherman Oaks", "state"=>"California", "country"=>"United States", "facility"=>"Pacific Oaks Med Group", "geoPoint"=>{"lat"=>34.15112, "lon"=>-118.44925}}, {"zip"=>"33146", "city"=>"Coral Gables", "state"=>"Florida", "country"=>"United States", "facility"=>"Community Research Initiative", "geoPoint"=>{"lat"=>25.72149, "lon"=>-80.26838}}, {"zip"=>"27710", "city"=>"Durham", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Duke Univ Med Ctr", "geoPoint"=>{"lat"=>35.99403, "lon"=>-78.89862}}, {"zip"=>"77006", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Houston Clinical Research Network", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Glaxo Wellcome", "class"=>"INDUSTRY"}}}}