Nctid:
NCT00000684
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D015658", "term"=>"HIV Infections"}, {"id"=>"D000163", "term"=>"Acquired Immunodeficiency Syndrome"}, {"id"=>"D007153", "term"=>"Immunologic Deficiency Syndromes"}], "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"=>"D007154", "term"=>"Immune System Diseases"}, {"id"=>"D012897", "term"=>"Slow Virus Diseases"}], "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", "asFound"=>"Human Immunodeficiency Virus", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"Human Immunodeficiency Virus", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "asFound"=>"Immunodeficiency", "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"=>"M15149", "name"=>"RNA Virus 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"=>"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"=>"Healthcare Workers", "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"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>10}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1991-04", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-26", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-11-03", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Infusions, Intravenous", "Dextran Sulfate", "Acquired Immunodeficiency Syndrome"], "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."}]}, "descriptionModule"=>{"briefSummary"=>"To determine the safety and effectiveness of dextran sulfate when it is administered intravenously at the maximum tolerated dose (MTD) as a treatment for HIV infection in AIDS patients. The effect of dextran sulfate on platelet survival will also be assessed in 3 patients to help determine the mechanism of thrombocytopenia (low platelets) noted in all patients receiving intravenous dextran sulfate in this study.\n\nDextran sulfate appears to inhibit HIV in experiments in the test tube, but studies conducted in humans to determine its effect on HIV when dextran sulfate is given orally have not been conclusive. It is hoped that this study will show that dextran sulfate administered intravenously", "detailedDescription"=>"Dextran sulfate appears to inhibit HIV in experiments in the test tube, but studies conducted in humans to determine its effect on HIV when dextran sulfate is given orally have not been conclusive. It is hoped that this study will show that dextran sulfate administered intravenously will have antiviral effects in patients who are infected with HIV.\n\nFollowing tests for evaluation, patients are hospitalized for 14 days. They are admitted to the hospital in the afternoon and, starting the next morning, receive a continuous infusion of dextran sulfate through an intravenous line for 14 days. The infusion is adjusted to maintain an activated partial thromboplastin time (APTT) of 50 to 65 seconds. Blood is withdrawn 5 times on the first day that patients receive dextran sulfate and at least once a day thereafter for safety. Patients' clinical condition, blood clotting, and blood platelets are monitored very closely."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"19 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Acetaminophen.\n\nPatients must have:\n\n-\n\nClinically documented AIDS or AIDS-related complex (ARC) defined as CDC group IVA or history of any of the findings that define CDC group IV subgroup C-2:\n\n* oral candidiasis, oral hairy leukoplakia, multidermatomal herpes zoster, recurrent nontyphoidal Salmonella bacteremia, or nocardiosis.\n\nPrior Medication:\n\nAllowed:\n\n* Acetaminophen.\n\nExclusion Criteria\n\nConcurrent Treatment:\n\nExcluded:\n\n* Intramuscular injections.\n\nPatients will be excluded from the study for the following reasons:\n\n* Acute illness requiring hospitalization or antiviral drug therapy for treatment.\n* Volunteers who have taken any antiviral medications, anticoagulants, antiplatelet medications, or any nonsteroidal anti-inflammatory drugs, except acetaminophen, within 2 weeks of study entry, or those who anticipate the need for such medication during the study.\n* Positive stool guaiac at screening.\n* Disorders of coagulation or any known contraindication to anticoagulation, including but not limited to gastrointestinal or other serious bleeding, major trauma or surgery within the past 2 months, stroke or suspicion of central nervous system (CNS) bleeding, Kaposi sarcoma (with or without proven gastrointestinal involvement), and any known CNS lesions that might be prone to bleed.\n* Allergy to dextran sulfate or heparin.\n* Acute or asymptomatic HIV infection.\n\nPrior Medication:\n\nExcluded:\n\n* Antiviral medications.\n* Anticoagulants.\n* Antiplatelet medications.\n* Any nonsteroidal anti-inflammatory drugs (except acetaminophen).\n\nPrior Treatment:\n\nExcluded:\n\n* Hospitalization for acute illness.\n\nPatients may not have any of the following diseases or symptoms:\n\n* Allergy to dextran sulfate or heparin.\n* Acute or asymptomatic HIV infection.\n* Acute illness requiring hospitalization.\n* Chronic anemia requiring transfusion within the past month.\n* Disorders of coagulation or any known contraindication to anticoagulation, including but not limited to gastrointestinal or other serious bleeding, major trauma or surgery within the past 2 months, stroke or suspicion of central nervous system (CNS) bleeding, Kaposi's sarcoma, and any known CNS lesions which might be prone to bleed."}, "identificationModule"=>{"nctId"=>"NCT00000684", "briefTitle"=>"Continuous High-Dose Intravenous Dextran Sulfate in Human Immunodeficiency Virus-Infected Individuals", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"Continuous High-Dose Intravenous Dextran Sulfate in Human Immunodeficiency Virus-Infected Individuals", "orgStudyIdInfo"=>{"id"=>"ACTG 105"}, "secondaryIdInfos"=>[{"id"=>"11080", "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 Adult AIDS CRS", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}], "overallOfficials"=>[{"name"=>"Lietman PS", "role"=>"STUDY_CHAIR"}, {"name"=>"Flexner CW", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
