Nctid:
NCT00000664
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D015658", "term"=>"HIV Infections"}, {"id"=>"D006679", "term"=>"HIV Seropositivity"}], "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"=>"M9742", "name"=>"HIV Seropositivity", "asFound"=>"HIV-Positive", "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"=>"D015215", "term"=>"Zidovudine"}, {"id"=>"D007376", "term"=>"Interleukin-2"}], "ancestors"=>[{"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D018712", "term"=>"Analgesics, Non-Narcotic"}, {"id"=>"D000700", "term"=>"Analgesics"}, {"id"=>"D018689", "term"=>"Sensory System Agents"}, {"id"=>"D018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000963", "term"=>"Antimetabolites"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D019380", "term"=>"Anti-HIV Agents"}, {"id"=>"D044966", "term"=>"Anti-Retroviral Agents"}], "browseLeaves"=>[{"id"=>"M10411", "name"=>"Interleukin-2", "asFound"=>"Temperature", "relevance"=>"HIGH"}, {"id"=>"M17920", "name"=>"Zidovudine", "asFound"=>"Underwent", "relevance"=>"HIGH"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}, {"id"=>"M20786", "name"=>"Analgesics, Non-Narcotic", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}, {"id"=>"M25428", "name"=>"Anti-Retroviral Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"count"=>26}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1994-12", "lastUpdateSubmitDate"=>"2008-08-01", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2008-08-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Polyethylene Glycols", "Interleukin-2", "Drug Evaluation", "Zidovudine"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"8095058", "type"=>"BACKGROUND", "citation"=>"Wood R, Montoya JG, Kundu SK, Schwartz DH, Merigan TC. Safety and efficacy of polyethylene glycol-modified interleukin-2 and zidovudine in human immunodeficiency virus type 1 infection: a phase I/II study. J Infect Dis. 1993 Mar;167(3):519-25. doi: 10.1093/infdis/167.3.519."}]}, "descriptionModule"=>{"briefSummary"=>"To determine the safety of polyethylene glycolated IL-2 (PEG IL2) administered weekly or biweekly (per amendment) in a setting of oral zidovudine (AZT). To determine the effect of PEG IL2 in combination with AZT on parameters assessing the immune system as well as HIV virus and antibody titers. To evaluate a chronic dosing study phase offered to patients who complete the initial 25-week regimen.\n\nRecent research has focused on enhancing cell-mediated immunity and reducing or eliminating viral replication (reproduction and growth). A main thrust of current treatment is the combination of antiviral drugs that may be more effective when combined than when each is used alone.", "detailedDescription"=>"Recent research has focused on enhancing cell-mediated immunity and reducing or eliminating viral replication (reproduction and growth). A main thrust of current treatment is the combination of antiviral drugs that may be more effective when combined than when each is used alone.\n\nFour groups are studied for a period of at least 25 weeks. Patients are observed for a minimum of 6 hours after infusion of PEG IL2. The 4 groups of patients are: Group A - asymptomatic with T4 count \\> 400 cells/mm3 (7 patients); Group B - asymptomatic with T4 count between 200 and 400 cells/mm3 (7 patients); Group C - asymptomatic with T4 count \\< 200 cells/mm3 (5 patients); Group D - diagnosed as having AIDS related complex (ARC) or AIDS (7 patients). All patients receive AZT. After a minimum 2-week period of AZT, patients receive an infusion of PEG IL-2 at 3 consecutive weekly intervals, followed by a 3-week period of AZT alone. This cycle (3 weeks of AZT and PEG IL-2 followed by 3 weeks of AZT alone) is repeated a total of three times (for a total of 18 weeks) followed by 8 weeks of AZT alone.\n\nPER AMENDMENT: Ten patients may qualify for one of two groups: Group 1 - T4 count 200 - 400 cells/mm3 and meet all criteria established for Group B of the original protocol; Group 2 - T4 count \\< 200 cells/mm3 and meet all criteria established for Groups C and D of original protocol. Patients will receive an amended schedule of PEG IL2 IV every other week for eight doses, with dose escalation every other week for eight weeks permitted only in Group 2 patients who failed to show a 20 percent rise in T4 count at week 9 and who suffered no CNS or other adverse events at the lower dose.\n\nPER ADDITIONAL AMENDMENT: Up to 10 additional patients may be treated at each dose of PEG IL2 on the biweekly schedule. Patients who respond to treatment on the biweekly schedule are eligible for an additional 9 weeks at their current dose."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Prophylactic pentamidine for Pneumocystis carinii pneumonia (PCP).\n* Topical steroids.\n\nPatients must:\n\n* Be HIV positive. Fit one of the zidovudine use groups listed in Disease Status. Be able to give informed consent.\n\nAllowed:\n\n* Basal cell carcinoma of the skin, in situ carcinoma of the cervix, Kaposi's sarcoma.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Major organ allograft.\n* Significant cardiac disease or central nervous system lesions.\n* Known previous intolerance to zidovudine (AZT) at 500 mg/day.\n* Active opportunistic infections. Score of \\> 0.5 on the ACTG AIDS dementia complex staging test. Any focal abnormality on neurologic exam.\n\nConcurrent Medication:\n\nExcluded:\n\n* Chemotherapy, hormonal therapy, or other immunotherapy.\n* Other investigational drugs, agents, or devices.\n* Beta-blockers.\n* Steroids other than topical.\n* Antihypertensive medication other than diuretics.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Radiation therapy.\n\nPatients with the following are excluded:\n\n* History of seizures. Concurrent neoplasms not specifically allowed.\n* Concomitant conditions listed in Exclusion Co-existing Conditions.\n\nPrior Medication:\n\nExcluded within 30 days prior to study entry:\n\n* Anti-HIV medication other than zidovudine (AZT).\n* Immunomodulators.\n* Systemic steroids.\n* Interferons.\n* Interleukins.\n* Other chemotherapy.\n\nPrior Treatment:\n\nExcluded within 30 days prior to study entry:\n\n* Radiation therapy.\n\nExcluded within 4 weeks prior to study entry:\n\n* Groups B, C, D\n* Transfusions.\n\nActive substance abuse."}, "identificationModule"=>{"nctId"=>"NCT00000664", "briefTitle"=>"Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine in HIV Positive, Asymptomatic and Symptomatic Individuals", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine in HIV Positive, Asymptomatic and Symptomatic Individuals", "orgStudyIdInfo"=>{"id"=>"ACTG 141"}, "secondaryIdInfos"=>[{"id"=>"CS-PG89-36"}, {"id"=>"FDA 70A"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Interleukin-2, Polyethylene Glycolated", "type"=>"DRUG"}, {"name"=>"Zidovudine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"94305", "city"=>"Stanford", "state"=>"California", "country"=>"United States", "facility"=>"Stanford Univ School of Medicine", "geoPoint"=>{"lat"=>37.42411, "lon"=>-122.16608}}], "overallOfficials"=>[{"name"=>"TC Merigan", "role"=>"STUDY_CHAIR"}, {"name"=>"J Korvick", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}}}}
