Nctid:
NCT00002388
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"=>"C106538", "term"=>"Abacavir"}], "ancestors"=>[{"id"=>"D018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"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"=>"M350770", "name"=>"Abacavir", "asFound"=>"Suspicion", "relevance"=>"HIGH"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "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"=>"M25428", "name"=>"Anti-Retroviral Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>48}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1998-11", "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"=>["HIV-1", "Reverse Transcriptase Inhibitors", "Anti-HIV Agents"], "conditions"=>["HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to see if it is safe to give 1592U89 to HIV-infected patients. This study also examines the effect 1592U89 has on plasma viral load (the level of HIV in the blood).", "detailedDescription"=>"Cohorts of 8 patients are entered sequentially into 1 of 6 1592U89 dosing regimens. All patients receive 12 weeks of monotherapy during the initial 12-week treatment phase.\n\nOn completion of the treatment phase, patients are offered continuation therapy with 1592U89 for a minimum of 12 weeks."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\nProphylaxis for opportunistic infections.\n\nPatients must have:\n\n* HIV-1 infection.\n* CD4 cell count 100 - 500 cells/mm3 within 3 to 5 weeks prior to study drug administration.\n* No active diagnosis of AIDS (other than non-visceral Kaposi's sarcoma) according to the 1993 CDC AIDS surveillance definition.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions and symptoms are excluded:\n\n* Malabsorption syndrome or other gastrointestinal dysfunction that may interfere with drug absorption.\n* Chronic disease such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that in the opinion of the investigator, would compromise the safety of the patient.\n\nConcurrent Medication:\n\nExcluded:\n\n* Immunomodulating agents.\n* Chemotherapeutic agents.\n* Antiretroviral therapy. NOTE:\n* Patients who elect to continue study treatment into the extended phase may, after consultation with their primary physician, combine 1592U89 at a recommended dose of 300 mg bid with other licensed antiretroviral drugs.\n\nConcurrent Treatment:\n\nExcluded:\n\nRadiation therapy.\n\nPatients with the following prior conditions are excluded:\n\n* History of clinically relevant hepatitis or pancreatitis within 6 months prior to study drug administration.\n* History of hypersensitivity, anaphylactic, or idiosyncratic reaction to nucleoside analogs.\n\nPrior Medication:\n\nExcluded:\n\n* Treatment with immunomodulating or cytotoxic chemotherapeutic agents within six weeks prior to study drug administration.\n* Antiretroviral therapy within 2 weeks prior to administration of study drugs.\n\nPrior Treatment:\n\nExcluded:\n\nRadiation therapy within six weeks prior to study drug administration. Current alcohol or illicit controlled substance use that in the opinion of the investigator, may interfere with the patient's ability to complete the study."}, "identificationModule"=>{"nctId"=>"NCT00002388", "briefTitle"=>"A Study of 1592U89 in HIV-Infected Patients", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Study to Evaluate the Single-Dose and Steady-State Pharmacokinetics/Dynamics of 1592U89 and Its Active Moiety, 1144U88 5'-Triphosphate (1144U88-TP) Following Six Different Dosing Regimens of 1592U89 in HIV-1 Infected Subjects", "orgStudyIdInfo"=>{"id"=>"238G"}, "secondaryIdInfos"=>[{"id"=>"CNAA1004"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Abacavir sulfate", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"60201", "city"=>"Evanston", "state"=>"Illinois", "country"=>"United States", "facility"=>"Evanston Hosp / Clinical Pharmacology Unit", "geoPoint"=>{"lat"=>42.04114, "lon"=>-87.69006}}, {"zip"=>"02115", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Fenway Community Health Ctr / Research Dept", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"12208", "city"=>"Albany", "state"=>"New York", "country"=>"United States", "facility"=>"Albany Med College / Albany Med Ctr Hosp", "geoPoint"=>{"lat"=>42.65258, "lon"=>-73.75623}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Glaxo Wellcome", "class"=>"INDUSTRY"}}}}