Nctid:
NCT00001035
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000003141", "term"=>"Communicable Diseases"}, {"id"=>"D000006506", "term"=>"Hepatitis A"}, {"id"=>"D000006526", "term"=>"Hepatitis C"}, {"id"=>"D000015658", "term"=>"HIV Infections"}, {"id"=>"D000000163", "term"=>"Acquired Immunodeficiency Syndrome"}, {"id"=>"D000006505", "term"=>"Hepatitis"}], "ancestors"=>[{"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000008107", "term"=>"Liver Diseases"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000006525", "term"=>"Hepatitis, Viral, Human"}, {"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000004769", "term"=>"Enterovirus Infections"}, {"id"=>"D000010850", "term"=>"Picornaviridae Infections"}, {"id"=>"D000012327", "term"=>"RNA Virus Infections"}, {"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D000018178", "term"=>"Flaviviridae Infections"}, {"id"=>"D000015229", "term"=>"Sexually Transmitted Diseases, Viral"}, {"id"=>"D000012749", "term"=>"Sexually Transmitted Diseases"}, {"id"=>"D000016180", "term"=>"Lentivirus Infections"}, {"id"=>"D000012192", "term"=>"Retroviridae Infections"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000007153", "term"=>"Immunologic Deficiency Syndromes"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}, {"id"=>"D000012897", "term"=>"Slow Virus Diseases"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M9592", "name"=>"Hepatitis A", "asFound"=>"Hepatitis", "relevance"=>"HIGH"}, {"id"=>"M9591", "name"=>"Hepatitis", "asFound"=>"Hepatitis", "relevance"=>"HIGH"}, {"id"=>"M9611", "name"=>"Hepatitis C", "asFound"=>"Hepatitis C", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M12825", "name"=>"Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M19410", "name"=>"AIDS-Related Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M11107", "name"=>"Liver Diseases", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M9610", "name"=>"Hepatitis, Viral, Human", "relevance"=>"LOW"}, {"id"=>"M7930", "name"=>"Enterovirus Infections", "relevance"=>"LOW"}, {"id"=>"M13745", "name"=>"Picornaviridae Infections", "relevance"=>"LOW"}, {"id"=>"M15149", "name"=>"RNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M2593", "name"=>"Blood-Borne Infections", "relevance"=>"LOW"}, {"id"=>"M20324", "name"=>"Flaviviridae 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"=>"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"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000007372", "term"=>"Interferons"}, {"id"=>"D000016898", "term"=>"Interferon-alpha"}, {"id"=>"D000077190", "term"=>"Interferon alpha-2"}, {"id"=>"D000015215", "term"=>"Zidovudine"}, {"id"=>"D000016049", "term"=>"Didanosine"}, {"id"=>"D000016047", "term"=>"Zalcitabine"}], "ancestors"=>[{"id"=>"D000000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000000998", "term"=>"Antiviral Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000007155", "term"=>"Immunologic Factors"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000000963", "term"=>"Antimetabolites"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D000019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000019380", "term"=>"Anti-HIV Agents"}, {"id"=>"D000044966", "term"=>"Anti-Retroviral Agents"}], "browseLeaves"=>[{"id"=>"M10407", "name"=>"Interferons", "asFound"=>"Continuous", "relevance"=>"HIGH"}, {"id"=>"M19243", "name"=>"Interferon-alpha", "asFound"=>"Extension", "relevance"=>"HIGH"}, {"id"=>"M1685", "name"=>"Interferon alpha-2", "asFound"=>"Monoclonal Antibody", "relevance"=>"HIGH"}, {"id"=>"M17920", "name"=>"Zidovudine", "asFound"=>"Tract", "relevance"=>"HIGH"}, {"id"=>"M18548", "name"=>"Didanosine", "asFound"=>"Catheter ablation", "relevance"=>"HIGH"}, {"id"=>"M18546", "name"=>"Zalcitabine", "asFound"=>"Route of administration: Intravenous", "relevance"=>"HIGH"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "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"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>10}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2012-04", "completionDateStruct"=>{"date"=>"1996-09", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2012-04-27", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2012-04-30", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["AIDS-Related Opportunistic Infections", "Interferon Alfa-2b", "Zalcitabine", "Didanosine", "Drug Therapy, Combination", "Acquired Immunodeficiency Syndrome", "Zidovudine", "Hepatitis C"], "conditions"=>["HIV Infections", "Hepatitis C"]}, "descriptionModule"=>{"briefSummary"=>"To investigate the toxicity of interferon alfa-2b ( IFN alfa-2b ) in combination with nucleoside analog therapy in HIV-positive patients with chronic hepatitis C. To determine the efficacy of treatment with IFN alfa-2b for chronic hepatitis C in patients with advanced HIV infections treated with nucleoside analog therapy.\n\nIFN alfa-2b has HIV inhibitory properties and has also been approved for treatment of chronic hepatitis C. Studies have shown that IFN alfa-2b is effective in asymptomatic HIV-positive patients with chronic hepatitis C, but the drug's benefit against hepatitis C in patients with advanced HIV infection has not been determined.", "detailedDescription"=>"IFN alfa-2b has HIV inhibitory properties and has also been approved for treatment of chronic hepatitis C. Studies have shown that IFN alfa-2b is effective in asymptomatic HIV-positive patients with chronic hepatitis C, but the drug's benefit against hepatitis C in patients with advanced HIV infection has not been determined.\n\nPatients receive interferon alpha-2b subcutaneously 3 times weekly for 6 months. If no response is seen after 18 weeks of therapy or if an initial response is followed by relapse while on therapy, dose is increased. Patients who require a dose escalation should continue on IFN alfa-2b for an additional 6 months. All patients will also receive available nucleoside analog therapy ( zidovudine, didanosine, zalcitabine ) at currently accepted doses as clinically appropriate."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"13 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Treatment or suppression of opportunistic infections with standard drugs.\n* Pneumovax, HIB, tetanus, influenza, and hepatitis B vaccines.\n* Clinically indicated antibiotics.\n* Short courses of steroids (\\< 21 days) for acute problems not related to hepatitis C.\n* Other regularly prescribed medications such as analgesics, nonsteroidal anti-inflammatory agents, antipyretics, allergy medications, and oral contraceptives.\n\nPatients must have:\n\n* HIV positivity.\n* Documented hepatitis C virus.\n* CD4 count \\<= 200 cells/mm3.\n* No severe liver disease (Grade C Childs-Pugh classification) or chronic liver disease not caused by hepatitis C.\n* Willingness to be followed for the duration of treatment and follow-up period.\n\nPrior Medication:\n\nAllowed:\n\n* Prior AZT, ddI, and ddC.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Hepatitis B (HBsAg positive).\n* Autoimmune hepatitis (FANA titer \\>= 1:160 and anti-smooth muscle antibody titer \\>= 1:160).\n* Wilson's disease.\n* alpha-1 antitrypsin deficiency.\n* Hemochromatosis.\n* Malignancy requiring systemic chemotherapy.\n\nConcurrent Medication:\n\nExcluded:\n\n* Nonnucleoside analog therapy for HIV.\n* Biologic response modifiers.\n* Systemic cytotoxic chemotherapy.\n* Chronic systemic steroid use.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Radiation therapy other than local irradiation to the skin.\n\nPrior Medication:\n\nExcluded:\n\n* Prednisone within 12 weeks prior to study entry (if patient has received prior daily doses for 1 month or longer duration).\n* Acute therapy for an infection within 2 weeks prior to study entry."}, "identificationModule"=>{"nctId"=>"NCT00001035", "briefTitle"=>"The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Phase I Pilot Study of the Safety and Efficacy of Interferon Alfa-2b (IFN Alfa-2b) in Combination With Nucleoside Analog Therapy in Patients With Combined Hepatitis C (HCV) and Advanced Human Immunodeficiency Virus (HIV) Infections", "orgStudyIdInfo"=>{"id"=>"ACTG 203P"}, "secondaryIdInfos"=>[{"id"=>"11180", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Interferon alfa-2b", "type"=>"DRUG"}, {"name"=>"Zidovudine", "type"=>"DRUG"}, {"name"=>"Zalcitabine", "type"=>"DRUG"}, {"name"=>"Didanosine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"USC CRS", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"462025250", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Indiana Univ. School of Medicine, Infectious Disease Research Clinic", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"zip"=>"10016", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"NY Univ. HIV/AIDS CRS", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}], "overallOfficials"=>[{"name"=>"Gill JC", "role"=>"STUDY_CHAIR"}, {"name"=>"Eyster ME", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Schering-Plough", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
