Nctid:
NCT00000690
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "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"=>"D003911", "term"=>"Dextrans"}], "ancestors"=>[{"id"=>"D000925", "term"=>"Anticoagulants"}, {"id"=>"D010952", "term"=>"Plasma Substitutes"}, {"id"=>"D001802", "term"=>"Blood Substitutes"}], "browseLeaves"=>[{"id"=>"M7106", "name"=>"Dextrans", "asFound"=>"Gemcitabine 1000 mg", "relevance"=>"HIGH"}, {"id"=>"M4244", "name"=>"Anticoagulants", "relevance"=>"LOW"}, {"id"=>"M13842", "name"=>"Plasma Substitutes", "relevance"=>"LOW"}, {"id"=>"M5083", "name"=>"Blood Substitutes", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anticoagulants", "abbrev"=>"AnCoag"}, {"name"=>"Blood Substitutes", "abbrev"=>"BlSubst"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>6}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1989-10", "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"=>["Reference Values", "Infusions, Intravenous", "Intestinal Absorption", "Dextran Sulfate", "Administration, Oral", "Blood Coagulation"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"1810188", "type"=>"BACKGROUND", "citation"=>"Flexner C, Barditch-Crovo PA, Kornhauser DM, Farzadegan H, Nerhood LJ, Chaisson RE, Bell KM, Lorentsen KJ, Hendrix CW, Petty BG, et al. Pharmacokinetics, toxicity, and activity of intravenous dextran sulfate in human immunodeficiency virus infection. Antimicrob Agents Chemother. 1991 Dec;35(12):2544-50. doi: 10.1128/AAC.35.12.2544."}, {"pmid"=>"9989768", "type"=>"BACKGROUND", "citation"=>"Hiebert LM, Wice SM, Jaques LB, Williams KE, Conly JM. Orally administered dextran sulfate is absorbed in HIV-positive individuals. J Lab Clin Med. 1999 Feb;133(2):161-70. doi: 10.1016/s0022-2143(99)90009-4."}, {"pmid"=>"2476054", "type"=>"BACKGROUND", "citation"=>"Lorentsen KJ, Hendrix CW, Collins JM, Kornhauser DM, Petty BG, Klecker RW, Flexner C, Eckel RH, Lietman PS. Dextran sulfate is poorly absorbed after oral administration. Ann Intern Med. 1989 Oct 1;111(7):561-6. doi: 10.7326/0003-4819-111-7-561."}]}, "descriptionModule"=>{"briefSummary"=>"To evaluate how the drug dextran sulfate (DS) is absorbed by the stomach and intestines when taken by mouth. To evaluate its effect on blood coagulation.\n\nDS has been reported to have anti-HIV activity. However, it is not known how much of the drug is absorbed into the bloodstream and can be used by the body when DS is taken by mouth.", "detailedDescription"=>"DS has been reported to have anti-HIV activity. However, it is not known how much of the drug is absorbed into the bloodstream and can be used by the body when DS is taken by mouth.\n\nOn 2nd day of hospitalization, each volunteer receives an oral dose of DS. Over the next 24 hours, 15 blood samples are obtained (from 15 separate needle sticks). On 4th day, each volunteer is given an injection of DS into vein. 18 blood samples are obtained. Blood is withdrawn before the infusion, at the end of the infusion, and 30 and 60 minutes after the infusion. All urine is collected."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT"], "maximumAge"=>"40 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Exclusion Criteria\n\nCo-existing Condition:\n\nVolunteers with any of the following are excluded:\n\n* Disorders of coagulation or disorders of plasma lipids.\n* Allergy to dextran sulfate, other sulfates, other dextrans.\n\nConcurrent Medication:\n\nExcluded:\n\n* Volunteers who anticipate need for medication during study.\n\nVolunteers with any of the following are excluded:\n\n* Disorders of coagulation or disorders of plasma lipids.\n* Allergy to dextran sulfate, other sulfates, other dextrans.\n\nPrior Medication:\n\nExcluded within 2 weeks of study entry:\n\n* Any medication.\n\nRisk Behavior:\n\nExcluded:\n\n* Ingestion of alcohol within 48 hours prior to study.\n* History of recent drug or alcohol abuse.\n* Disorders of coagulation or disorders of plasma lipids.\n* Allergy to dextran sulfate, other sulfates, other dextrans.\n\nVolunteers selected are:\n\n* In good general health as determined by screening history, physical examination, and laboratory panel within established limits of normal for hospital laboratory.\n* Consenting volunteers.\n* Available for 6 days of continuous hospitalization."}, "identificationModule"=>{"nctId"=>"NCT00000690", "briefTitle"=>"Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers", "orgStudyIdInfo"=>{"id"=>"ACTG 078"}, "secondaryIdInfos"=>[{"id"=>"11053", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Dextran sulfate", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"21287", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Hosp", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}], "overallOfficials"=>[{"name"=>"P Lietman", "role"=>"STUDY_CHAIR"}, {"name"=>"KJ Lorentsen", "role"=>"STUDY_CHAIR"}, {"name"=>"CW Hendrix", "role"=>"STUDY_CHAIR"}, {"name"=>"JM Collins", "role"=>"STUDY_CHAIR"}, {"name"=>"DM Kornhauser", "role"=>"STUDY_CHAIR"}, {"name"=>"BG Petty", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
