Nctid:
NCT00000650
Payload:
{"FullStudy"=>{"Rank"=>498680, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000015658", "ConditionMeshTerm"=>"HIV Infections"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000086982", "ConditionAncestorTerm"=>"Blood-Borne Infections"}, {"ConditionAncestorId"=>"D000003141", "ConditionAncestorTerm"=>"Communicable Diseases"}, {"ConditionAncestorId"=>"D000007239", "ConditionAncestorTerm"=>"Infections"}, {"ConditionAncestorId"=>"D000015229", "ConditionAncestorTerm"=>"Sexually Transmitted Diseases, Viral"}, {"ConditionAncestorId"=>"D000012749", "ConditionAncestorTerm"=>"Sexually Transmitted Diseases"}, {"ConditionAncestorId"=>"D000016180", "ConditionAncestorTerm"=>"Lentivirus Infections"}, {"ConditionAncestorId"=>"D000012192", "ConditionAncestorTerm"=>"Retroviridae Infections"}, {"ConditionAncestorId"=>"D000012327", "ConditionAncestorTerm"=>"RNA Virus Infections"}, {"ConditionAncestorId"=>"D000014777", "ConditionAncestorTerm"=>"Virus Diseases"}, {"ConditionAncestorId"=>"D000091662", "ConditionAncestorTerm"=>"Genital Diseases"}, {"ConditionAncestorId"=>"D000091642", "ConditionAncestorTerm"=>"Urogenital Diseases"}, {"ConditionAncestorId"=>"D000007153", "ConditionAncestorTerm"=>"Immunologic Deficiency Syndromes"}, {"ConditionAncestorId"=>"D000007154", "ConditionAncestorTerm"=>"Immune System Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M16355", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10283", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6368", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3522", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18250", "ConditionBrowseLeafName"=>"HIV Infections", "ConditionBrowseLeafAsFound"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M10199", "ConditionBrowseLeafName"=>"Immunologic Deficiency Syndromes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2593", "ConditionBrowseLeafName"=>"Blood-Borne Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15558", "ConditionBrowseLeafName"=>"Sexually Transmitted Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17933", "ConditionBrowseLeafName"=>"Sexually Transmitted Diseases, Viral", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18640", "ConditionBrowseLeafName"=>"Lentivirus Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15026", "ConditionBrowseLeafName"=>"Retroviridae Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17522", "ConditionBrowseLeafName"=>"Virus Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15149", "ConditionBrowseLeafName"=>"RNA Virus Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2876", "ConditionBrowseLeafName"=>"Genital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2875", "ConditionBrowseLeafName"=>"Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10200", "ConditionBrowseLeafName"=>"Immune System Diseases", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000004050", "InterventionMeshTerm"=>"Ditiocarb"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000276", "InterventionAncestorTerm"=>"Adjuvants, Immunologic"}, {"InterventionAncestorId"=>"D000007155", "InterventionAncestorTerm"=>"Immunologic Factors"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000000998", "InterventionAncestorTerm"=>"Antiviral Agents"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"InterventionAncestorId"=>"D000002614", "InterventionAncestorTerm"=>"Chelating Agents"}, {"InterventionAncestorId"=>"D000064449", "InterventionAncestorTerm"=>"Sequestering Agents"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M7239", "InterventionBrowseLeafName"=>"Ditiocarb", "InterventionBrowseLeafAsFound"=>"Post-PV MF", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3628", "InterventionBrowseLeafName"=>"Adjuvants, Immunologic", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M10201", "InterventionBrowseLeafName"=>"Immunologic Factors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4314", "InterventionBrowseLeafName"=>"Antiviral Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4214", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M5860", "InterventionBrowseLeafName"=>"Chelating Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Not Applicable"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignMaskingInfo"=>{"DesignMasking"=>"None (Open Label)"}, "DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"12"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"October 2021", "CompletionDateStruct"=>{"CompletionDate"=>"September 1996", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"October 26, 2021", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"August 30, 2001", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"October 27, 2021", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"August 31, 2001", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Drug Evaluation", "Ditiocarb", "Acquired Immunodeficiency Syndrome"]}, "ConditionList"=>{"Condition"=>["HIV Infections"]}}, "DescriptionModule"=>{"BriefSummary"=>"To determine, in HIV-infected patients, the magnitude and duration of the biological effects of ditiocarb sodium (sodium diethyldithiocarbamate; DTC) that may be relevant to treatment of HIV infection.\n\nDTC has been studied in previous clinical trials in HIV-infected patients with the suggestion of delay in disease progression to AIDS and improvement in CD4 counts while on the drug.", "DetailedDescription"=>"DTC has been studied in previous clinical trials in HIV-infected patients with the suggestion of delay in disease progression to AIDS and improvement in CD4 counts while on the drug.\n\nTwo groups of patients, one group asymptomatic and the other with AIDS diagnosis, are enrolled in the study. All patients receive DTC intravenously once a week for two weeks. Drugs are given on days 1 and 8. Blood samples are drawn on days 1, 3, 5, 8, 10, and 12."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"50 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nPatients must:\n\nHave HIV infection.\nBe asymptomatic (group 1) or have AIDS (group 2).\nBe able to understand and follow instructions.\n\nConcurrent Medication:\n\nAllowed:\n\nGROUP 2:\n\nAnti-HIV therapy.\nSystemic prophylaxis or maintenance therapy for any AIDS-defining opportunistic infection excluding agents considered immunomodulators or immunosuppressants.\nTopical nystatin.\nClotrimazole troches.\nAcyclovir.\nDapsone.\nTrimethoprim / sulfamethoxazole (T/S).\nFluconazole.\nKetoconazole.\nAerosolized pentamidine.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\nALL PATIENTS:\n\nKnown hypersensitivity to disulfiram or diethyldithiocarbamate (DTC).\nTransfusion dependence.\n\nGROUP 1 PATIENTS ONLY:\n\nOral candidiasis documented by morphology or by a response to antifungal therapy.\nOral hairy leukoplakia.\nOccurrence of herpes zoster in a single dermatomal distribution.\nRecurrent seborrheic dermatitis.\nUnintentional weight loss in excess of 10 pounds or 10 percent of usual body weight within 2 years prior to study.\nUnexplained temperature above 38 degrees C on more than 5 consecutive days or on more than 10 days in any 30 days within 2 years of expected study entry.\nUnexplained diarrhea defined by two or more stools/day for at least 14 days during a 120-day interval.\nEvidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, renal, or dermatologic disease as demonstrated by history, physical, and laboratory evaluation.\n\nGROUP 2 PATIENTS ONLY:\n\nConcurrent neoplasms other than Kaposi's sarcoma or basal cell carcinoma of the skin.\nDiagnosis of an acute opportunistic infection within 3 weeks of study entry or had treatment initiated for an opportunistic infection within 3 weeks of study entry.\n\nConcurrent Medication:\n\nExcluded:\n\nALL PATIENTS:\n\nRecombinant erythropoietin.\n\nGROUP 1:\n\nAntiretroviral medications.\n\nGROUP 2:\n\nImmunomodulators or immunosuppressants.\n\nConcurrent Treatment:\n\nExcluded:\n\nRequirement for blood transfusions more than once a month.\n\nPatients with the following prior conditions are excluded:\n\nGROUP 1 PATIENTS ONLY:\n\nOral candidiasis documented by morphology or by a response to antifungal therapy.\nOral hairy leukoplakia.\nOccurrence of herpes zoster in a single dermatomal distribution.\nRecurrent seborrheic dermatitis.\nUnintentional weight loss in excess of 10 pounds or 10 percent of usual body weight within 2 years prior to study.\nUnexplained temperature above 38 degrees C on more than 5 consecutive days or on more than 10 days in any 30-day period within 2 years of expected study entry.\nUnexplained diarrhea defined by two or more stools/day for at least 14 days during a 120-day interval.\nEvidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, renal, or dermatologic disease as demonstrated by history, physical, and laboratory evaluation.\n\nGROUP 2 PATIENTS ONLY:\n\nDiagnosis of an acute opportunistic infection within 3 weeks of study entry or had treatment initiated for an opportunistic infection within 3 weeks of study entry.\n\nPrior Medication:\n\nExcluded:\n\nALL PATIENTS:\n\nCorticosteroids, cytotoxic agents, or immunomodulating agents within 30 days prior to study entry.\nChronic Antabuse (disulfiram) therapy.\n\nGROUP 1 ONLY:\n\nAntiretrovial medications within 1 week prior to study entry.\n\nPrior Treatment:\n\nExcluded:\n\nTransfusion within 7 days of study entry.\nRadiation therapy within 30 days prior to study entry.\n\nUnable to refrain from the use of alcohol for the duration of the study."}, "IdentificationModule"=>{"NCTId"=>"NCT00000650", "BriefTitle"=>"An Assessment of the In Vivo Biological Effects of Diethyldithiocarbamate (DTC) in HIV-Infected Patients", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"An Assessment of the In Vivo Biological Effects of Diethyldithiocarbamate (DTC) in HIV-Infected Patients", "OrgStudyIdInfo"=>{"OrgStudyId"=>"ACTG 166"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"11141", "SecondaryIdType"=>"Registry Identifier", "SecondaryIdDomain"=>"DAIDS ES Registry Number"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Ditiocarb sodium", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"21287", "LocationCity"=>"Baltimore", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"Johns Hopkins Adult AIDS CRS"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"PS Lietman", "OverallOfficialRole"=>"Study Chair"}, {"OverallOfficialName"=>"P Barditch-Crovo", "OverallOfficialRole"=>"Study Chair"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"Connaught Laboratories", "CollaboratorClass"=>"INDUSTRY"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}