Nctid:
NCT00002157
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D019247", "term"=>"HIV Wasting Syndrome"}, {"id"=>"D019282", "term"=>"Wasting Syndrome"}, {"id"=>"D013577", "term"=>"Syndrome"}, {"id"=>"D002100", "term"=>"Cachexia"}], "ancestors"=>[{"id"=>"D004194", "term"=>"Disease"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D015658", "term"=>"HIV Infections"}, {"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"}, {"id"=>"D015431", "term"=>"Weight Loss"}, {"id"=>"D001836", "term"=>"Body Weight Changes"}, {"id"=>"D001835", "term"=>"Body Weight"}, {"id"=>"D013851", "term"=>"Thinness"}, {"id"=>"D008659", "term"=>"Metabolic Diseases"}, {"id"=>"D009748", "term"=>"Nutrition Disorders"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "asFound"=>"Syndrome", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M21265", "name"=>"Wasting Syndrome", "asFound"=>"Wasting Syndrome", "relevance"=>"HIGH"}, {"id"=>"M5363", "name"=>"Cachexia", "asFound"=>"Wasting Syndrome", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M21232", "name"=>"HIV Wasting Syndrome", "asFound"=>"HIV Wasting Syndrome", "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"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M18102", "name"=>"Weight Loss", "relevance"=>"LOW"}, {"id"=>"M5114", "name"=>"Body Weight", "relevance"=>"LOW"}, {"id"=>"M5115", "name"=>"Body Weight Changes", "relevance"=>"LOW"}, {"id"=>"M16614", "name"=>"Thinness", "relevance"=>"LOW"}, {"id"=>"M11639", "name"=>"Metabolic Diseases", "relevance"=>"LOW"}, {"id"=>"M12684", "name"=>"Nutrition Disorders", "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"}, {"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D013792", "term"=>"Thalidomide"}], "ancestors"=>[{"id"=>"D007166", "term"=>"Immunosuppressive Agents"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D007917", "term"=>"Leprostatic Agents"}, {"id"=>"D000900", "term"=>"Anti-Bacterial Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D020533", "term"=>"Angiogenesis Inhibitors"}, {"id"=>"D043924", "term"=>"Angiogenesis Modulating Agents"}, {"id"=>"D006133", "term"=>"Growth Substances"}, {"id"=>"D006131", "term"=>"Growth Inhibitors"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}], "browseLeaves"=>[{"id"=>"M16559", "name"=>"Thalidomide", "asFound"=>"Expression", "relevance"=>"HIGH"}, {"id"=>"M10212", "name"=>"Immunosuppressive Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M22318", "name"=>"Angiogenesis Inhibitors", "relevance"=>"LOW"}, {"id"=>"M9231", "name"=>"Growth Inhibitors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1998-12", "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"=>["Acquired Immunodeficiency Syndrome", "Cachexia", "Thalidomide"], "conditions"=>["HIV Infections", "HIV Wasting Syndrome"]}, "descriptionModule"=>{"briefSummary"=>"To allow patients with HIV-associated wasting to receive thalidomide treatment at 1 of 2 doses. To gain safety and efficacy data from a broader base of patients with HIV-associated wasting in order to support Celgene's pivotal placebo-controlled study.", "detailedDescription"=>"Patients are randomized to receive thalidomide at 1 of 2 doses for 12 weeks initially, with response assessed at weeks 2, 4, 8, and 12. Patients failing the low dose will be eligible to increase the dose to the higher dose. Treatment may continue indefinitely. After 12 weeks, patients continuing treatment are evaluated every 2 months for up to 6 additional months, then every 6 months thereafter."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Antiretroviral therapy.\n* Prophylaxis or treatment for opportunistic infection.\n\nPatients must have:\n\nHIV-associated wasting.\n\nPrior Medication:\n\nAllowed:\n\n* Prior enrollment on Celgene's placebo-controlled thalidomide study, provided patient meets specified criteria for not continuing on that study."}, "identificationModule"=>{"nctId"=>"NCT00002157", "briefTitle"=>"Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome", "orgStudyIdInfo"=>{"id"=>"230B"}, "secondaryIdInfos"=>[{"id"=>"W-002"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Thalidomide", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"07059", "city"=>"Warren", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Celgene Corp", "geoPoint"=>{"lat"=>40.60822, "lon"=>-74.51803}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Celgene Corporation", "class"=>"INDUSTRY"}}}}
