Nctid:
NCT00000646
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D009336", "term"=>"Necrosis"}], "ancestors"=>[{"id"=>"D010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M21265", "name"=>"Wasting Syndrome", "relevance"=>"LOW"}, {"id"=>"M5363", "name"=>"Cachexia", "relevance"=>"LOW"}, {"id"=>"M12284", "name"=>"Necrosis", "asFound"=>"Necrosis", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "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"=>"D010431", "term"=>"Pentoxifylline"}], "ancestors"=>[{"id"=>"D010726", "term"=>"Phosphodiesterase Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D010975", "term"=>"Platelet Aggregation Inhibitors"}, {"id"=>"D011837", "term"=>"Radiation-Protective Agents"}, {"id"=>"D020011", "term"=>"Protective Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D014665", "term"=>"Vasodilator Agents"}, {"id"=>"D016166", "term"=>"Free Radical Scavengers"}, {"id"=>"D000975", "term"=>"Antioxidants"}], "browseLeaves"=>[{"id"=>"M13342", "name"=>"Pentoxifylline", "asFound"=>"Precision", "relevance"=>"HIGH"}, {"id"=>"M13629", "name"=>"Phosphodiesterase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M13865", "name"=>"Platelet Aggregation Inhibitors", "relevance"=>"LOW"}, {"id"=>"M21869", "name"=>"Protective Agents", "relevance"=>"LOW"}, {"id"=>"M14684", "name"=>"Radiation-Protective Agents", "relevance"=>"LOW"}, {"id"=>"M17412", "name"=>"Vasodilator Agents", "relevance"=>"LOW"}, {"id"=>"M4292", "name"=>"Antioxidants", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Vasodilator Agents", "abbrev"=>"VaDiAg"}, {"name"=>"Platelet Aggregation Inhibitors", "abbrev"=>"PlAggInh"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>54}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1993-03", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-26", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-11-02", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Pentoxifylline", "Virus Replication", "Tumor Necrosis Factor", "Drug Evaluation", "Acquired Immunodeficiency Syndrome", "Cachexia", "Drug Synergism"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Dezube BJ, Lederman MM, Pardee AB, Chapman B, Korvick J, Crumpacker CS. Pentoxifylline (Trental, PTX) decreases tumor necrosis factor (TNF) & may decrease HIV replication in AIDS patients. ACTG #160 Team. Int Conf AIDS. 1993 Jun 6-11;9(1):492 (abstract no PO-B28-2142)"}, {"pmid"=>"8099612", "type"=>"BACKGROUND", "citation"=>"Dezube BJ, Pardee AB, Chapman B, Beckett LA, Korvick JA, Novick WJ, Chiurco J, Kasdan P, Ahlers CM, Ecto LT, et al. Pentoxifylline decreases tumor necrosis factor expression and serum triglycerides in people with AIDS. NIAID AIDS Clinical Trials Group. J Acquir Immune Defic Syndr (1988). 1993 Jul;6(7):787-94."}, {"type"=>"BACKGROUND", "citation"=>"Dezube BJ, Pardee AB, Chapman B, Beckett L, Korvick J, Ahlers CM, Ecto L, Chatis P, Crumpacker CS. Pentoxifylline (trental) decreases tumor necrosis factor (TNF) and HIV replication in patients with AIDS. ACTG #160 Team. AIDS Clinical Trial Group. Int Conf AIDS. 1992 Jul 19-24;8(1):Mo8 (abstract no MoB 0019)"}, {"pmid"=>"7769305", "type"=>"BACKGROUND", "citation"=>"Dezube BJ, Lederman MM, Spritzler JG, Chapman B, Korvick JA, Flexner C, Dando S, Mattiacci MR, Ahlers CM, Zhang L, et al. High-dose pentoxifylline in patients with AIDS: inhibition of tumor necrosis factor production. National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group. J Infect Dis. 1995 Jun;171(6):1628-32. doi: 10.1093/infdis/171.6.1628."}, {"pmid"=>"1403638", "type"=>"BACKGROUND", "citation"=>"Dezube BJ, Pardee AB, Beckett LA, Ahlers CM, Ecto L, Allen-Ryan J, Anisowicz A, Sager R, Crumpacker CS. Cytokine dysregulation in AIDS: in vivo overexpression of mRNA of tumor necrosis factor-alpha and its correlation with that of the inflammatory cytokine GRO. J Acquir Immune Defic Syndr (1988). 1992;5(11):1099-104."}]}, "descriptionModule"=>{"briefSummary"=>"To determine whether pentoxifylline lowers tumor necrosis factor (TNF) levels in AIDS patients. Pentoxifylline decreases tumor necrosis factor (TNF), and therefore should decrease such TNF-intensified events as cachexia, enhanced HIV expression, and inhibition of zidovudine (AZT) activity.", "detailedDescription"=>"Pentoxifylline decreases tumor necrosis factor (TNF), and therefore should decrease such TNF-intensified events as cachexia, enhanced HIV expression, and inhibition of zidovudine (AZT) activity.\n\nTwenty-seven AIDS patients with elevated TNF and less than 300 CD4 cells are given pentoxifylline 3 times a day for 8 weeks. If no significant changes are seen in virologic, immunologic, or related measures, 27 additional patients are given a higher dose of pentoxifylline 3 times a day for eight weeks."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nRequired:\n\n* Zidovudine (AZT), didanosine (ddI), dideoxycytidine (ddC), or a combination thereof, at current dosage for the 8 weeks of study treatment.\n* Prophylaxis (e.g., aerosolized pentamidine, trimethoprim / sulfamethoxazole (TMP / SMX), dapsone for Pneumocystis carinii pneumonia (PCP) if CD4 cell count is \\< 200 cells/mm3\n\nAllowed:\n\n* Concurrent maintenance therapy for opportunistic infections.\n\nPrior Medication: Required:\n\n* Zidovudine (AZT), didanosine (ddI), dideoxycytidine (ddC), or a combination thereof, for at least 2 months.\n\nPatients must have the following:\n\n* Diagnosis of AIDS.\n* Documented HIV seropositivity.\n* Ability to give informed consent and willingness to comply with visit schedule and all procedures.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Lymphoma or visceral Kaposi's sarcoma.\n* Active peptic ulcer or bleeding disorder.\n* Hemophilia. Known intolerance to pentoxifylline, theophylline, or caffeine.\n\nConcurrent Medication:\n\nExcluded:\n\n* Warfarin and heparin.\n* Biological response modifiers (e.g., erythropoietin, interferon, G-CSF, GM-CSF).\n\nCytotoxic chemotherapy.\n\n* Megestrol acetate. Corticosteroids.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Radiation therapy. Blood products or transfusions.\n\nPatients with the following are excluded:\n\n* Presence of an active opportunistic infection.\n* Major surgery within 30 days of study treatment.\n\nPrior Medication:\n\nExcluded:\n\n* Biological response modifiers (including interferon, interleukin), corticosteroids, or megestrol acetate within 14 days of first (screening) TNF level.\n* Erythropoietin dependency or within 30 days of study treatment.\n\nPrior Treatment:\n\nExcluded:\n\n* Transfusion or blood product dependency or use within 30 days of study treatment."}, "identificationModule"=>{"nctId"=>"NCT00000646", "briefTitle"=>"Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS", "orgStudyIdInfo"=>{"id"=>"ACTG 160"}, "secondaryIdInfos"=>[{"id"=>"11135", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Pentoxifylline", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"02215", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Beth Israel Deaconess - East Campus A0102 CRS", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"city"=>"Cleveland", "state"=>"Ohio", "country"=>"United States", "facility"=>"Case CRS", "geoPoint"=>{"lat"=>41.4995, "lon"=>-81.69541}}], "overallOfficials"=>[{"name"=>"Dezube B", "role"=>"STUDY_CHAIR"}, {"name"=>"Crumpacker C", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Hoechst Marion Roussel", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
