Nctid:
NCT00001758
Payload:
{"FullStudy"=>{"Rank"=>491955, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"May 02, 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"=>"M10283", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6368", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18250", "ConditionBrowseLeafName"=>"HIV Infections", "ConditionBrowseLeafAsFound"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M3522", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "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"=>"M16355", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10199", "ConditionBrowseLeafName"=>"Immunologic Deficiency Syndromes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10200", "ConditionBrowseLeafName"=>"Immune System Diseases", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"C000098320", "InterventionMeshTerm"=>"Efavirenz"}, {"InterventionMeshId"=>"C000106538", "InterventionMeshTerm"=>"Abacavir"}, {"InterventionMeshId"=>"C000095108", "InterventionMeshTerm"=>"Amprenavir"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000018894", "InterventionAncestorTerm"=>"Reverse Transcriptase Inhibitors"}, {"InterventionAncestorId"=>"D000019384", "InterventionAncestorTerm"=>"Nucleic Acid Synthesis Inhibitors"}, {"InterventionAncestorId"=>"D000004791", "InterventionAncestorTerm"=>"Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000000998", "InterventionAncestorTerm"=>"Antiviral Agents"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"InterventionAncestorId"=>"D000065688", "InterventionAncestorTerm"=>"Cytochrome P-450 CYP2C9 Inhibitors"}, {"InterventionAncestorId"=>"D000065607", "InterventionAncestorTerm"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000065689", "InterventionAncestorTerm"=>"Cytochrome P-450 CYP2C19 Inhibitors"}, {"InterventionAncestorId"=>"D000065695", "InterventionAncestorTerm"=>"Cytochrome P-450 CYP2B6 Inducers"}, {"InterventionAncestorId"=>"D000065693", "InterventionAncestorTerm"=>"Cytochrome P-450 Enzyme Inducers"}, {"InterventionAncestorId"=>"D000065701", "InterventionAncestorTerm"=>"Cytochrome P-450 CYP3A Inducers"}, {"InterventionAncestorId"=>"D000019380", "InterventionAncestorTerm"=>"Anti-HIV Agents"}, {"InterventionAncestorId"=>"D000044966", "InterventionAncestorTerm"=>"Anti-Retroviral Agents"}, {"InterventionAncestorId"=>"D000000904", "InterventionAncestorTerm"=>"Antibiotics, Antitubercular"}, {"InterventionAncestorId"=>"D000000995", "InterventionAncestorTerm"=>"Antitubercular Agents"}, {"InterventionAncestorId"=>"D000000900", "InterventionAncestorTerm"=>"Anti-Bacterial Agents"}, {"InterventionAncestorId"=>"D000017320", "InterventionAncestorTerm"=>"HIV Protease Inhibitors"}, {"InterventionAncestorId"=>"D000084762", "InterventionAncestorTerm"=>"Viral Protease Inhibitors"}, {"InterventionAncestorId"=>"D000011480", "InterventionAncestorTerm"=>"Protease Inhibitors"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M350770", "InterventionBrowseLeafName"=>"Abacavir", "InterventionBrowseLeafAsFound"=>"Exchange", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M340137", "InterventionBrowseLeafName"=>"Efavirenz", "InterventionBrowseLeafAsFound"=>"Loading dose", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M25428", "InterventionBrowseLeafName"=>"Anti-Retroviral Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M339956", "InterventionBrowseLeafName"=>"Amprenavir", "InterventionBrowseLeafAsFound"=>"Thoracolumbar", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M20935", "InterventionBrowseLeafName"=>"Reverse Transcriptase Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7951", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4314", "InterventionBrowseLeafName"=>"Antiviral Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4214", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M30537", "InterventionBrowseLeafName"=>"Cytochrome P-450 Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M21350", "InterventionBrowseLeafName"=>"Anti-HIV Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4222", "InterventionBrowseLeafName"=>"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4311", "InterventionBrowseLeafName"=>"Antitubercular Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4224", "InterventionBrowseLeafName"=>"Antibiotics, Antitubercular", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M19609", "InterventionBrowseLeafName"=>"HIV Protease Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M14343", "InterventionBrowseLeafName"=>"Protease Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"25"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"November 1997"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"August 2003", "CompletionDateStruct"=>{"CompletionDate"=>"August 2003"}, "LastUpdateSubmitDate"=>"March 3, 2008", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"March 4, 2008", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Antiretroviral", "HIV-1", "1592U89", "141W94", "DMP 266"]}, "ConditionList"=>{"Condition"=>["HIV Infection"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"7594659", "ReferenceType"=>"background", "ReferenceCitation"=>"Livington DJ, Pazhanisamy S, Porter DJ, Partaledis JA, Tung RD, Painter GR. Weak binding of VX-478 to human plasma proteins and implications for anti-human immunodeficiency virus therapy. J Infect Dis. 1995 Nov;172(5):1238-45. doi: 10.1093/infdis/172.5.1238."}, {"ReferencePMID"=>"7636964", "ReferenceType"=>"background", "ReferenceCitation"=>"Partaledis JA, Yamaguchi K, Tisdale M, Blair EE, Falcione C, Maschera B, Myers RE, Pazhanisamy S, Futer O, Cullinan AB, et al. In vitro selection and characterization of human immunodeficiency virus type 1 (HIV-1) isolates with reduced sensitivity to hydroxyethylamino sulfonamide inhibitors of HIV-1 aspartyl protease. J Virol. 1995 Sep;69(9):5228-35. doi: 10.1128/JVI.69.9.5228-5235.1995."}, {"ReferencePMID"=>"7486905", "ReferenceType"=>"background", "ReferenceCitation"=>"Tisdale M, Myers RE, Maschera B, Parry NR, Oliver NM, Blair ED. Cross-resistance analysis of human immunodeficiency virus type 1 variants individually selected for resistance to five different protease inhibitors. Antimicrob Agents Chemother. 1995 Aug;39(8):1704-10. doi: 10.1128/AAC.39.8.1704."}]}}, "DescriptionModule"=>{"BriefSummary"=>"This study will continue to treat and collect safety and efficacy data on patients who participated in Glaxo-Wellcome's multi-center study on combination therapy with abacavir, amprenavir and efavirenz (A Phase II Study Evaluating the Safety and Antiviral Activity of Combination Therapy with 1592U89, 141W94 and DMP 266 (Sustiva) in HIV-1 Infected Subjects with Detectable [greater than 400 Copies/mL] HIV-1 Plasma RNA Despite Treatment with a Protease Inhibitor-Containing Regimen).\n\nHIV-infected patients 18 years of age and older who participated in the above study at the NIH site may be eligible for the current study. Participants will be followed every 3 months with a general health evaluation and laboratory tests. This is a NIH study, and information will not be provided to Glaxo Wellcome", "DetailedDescription"=>"In this open-label, single-arm study, HIV-1 infected patients who had, at study entry, a viral burden of at least 500 copies/mL despite 20 weeks of treatment with a protease inhibitor receive combination therapy with three antiretroviral agents that were investigational at the start of study but have since been approved: abacavir, amprenavir, and efavirenz. At the end of 16 weeks, the addition of other antiretroviral agents to the study regimen was permitted. This was originally a multi-center study, but it has been closed at all other sites. It remains open at the NIH to continue to provide therapy to subjects who have received benefit as determined by a decline in viral load from baseline. Safety and viral load data continue to be collected."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"INCLUSION/EXCLUSION CRITERIA:\n\nSubjects who were previously enrolled in this protocol when it was a multi-center study and who signed the new informed consent were enrolled. There has been and will be no other new enrollment. Thus, subjects who were not previously enrolled are excluded.\n\nSubjects are adults infected with HIV-1 who had, prior to study enrollment, a plasma viral load of at least 500 copies/mL despite at least 20 weeks of treatment with a protease inhibitor and without change in protease inhibitor therapy in the 12 weeks prior to enrollment."}, "IdentificationModule"=>{"NCTId"=>"NCT00001758", "BriefTitle"=>"Continued Antiretroviral Therapy With Abacavir, Amprenavir and Efavirenz", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Continued Salvage Anti-Retroviral Therapy With Abacavir, Amprenavir, and Efavirenz", "OrgStudyIdInfo"=>{"OrgStudyId"=>"980031"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"98-I-0031"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Abacavir", "InterventionType"=>"Drug"}, {"InterventionName"=>"Amprenavir", "InterventionType"=>"Drug"}, {"InterventionName"=>"Efavirenz", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}}}}}}
