Nctid:
NCT00000778
Payload:
{"FullStudy"=>{"Rank"=>474120, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 01, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000014376", "ConditionMeshTerm"=>"Tuberculosis"}, {"ConditionMeshId"=>"D000014397", "ConditionMeshTerm"=>"Tuberculosis, Pulmonary"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000007239", "ConditionAncestorTerm"=>"Infections"}, {"ConditionAncestorId"=>"D000009164", "ConditionAncestorTerm"=>"Mycobacterium Infections"}, {"ConditionAncestorId"=>"D000000193", "ConditionAncestorTerm"=>"Actinomycetales Infections"}, {"ConditionAncestorId"=>"D000016908", "ConditionAncestorTerm"=>"Gram-Positive Bacterial Infections"}, {"ConditionAncestorId"=>"D000001424", "ConditionAncestorTerm"=>"Bacterial Infections"}, {"ConditionAncestorId"=>"D000001423", "ConditionAncestorTerm"=>"Bacterial Infections and Mycoses"}, {"ConditionAncestorId"=>"D000012141", "ConditionAncestorTerm"=>"Respiratory Tract Infections"}, {"ConditionAncestorId"=>"D000008171", "ConditionAncestorTerm"=>"Lung Diseases"}, {"ConditionAncestorId"=>"D000012140", "ConditionAncestorTerm"=>"Respiratory Tract Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M9973", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6058", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M16045", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M16817", "ConditionBrowseLeafName"=>"Tuberculosis", "ConditionBrowseLeafAsFound"=>"Tuberculosis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M17940", "ConditionBrowseLeafName"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9889", "ConditionBrowseLeafName"=>"Immunologic Deficiency Syndromes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3212", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M16837", "ConditionBrowseLeafName"=>"Tuberculosis, Pulmonary", "ConditionBrowseLeafAsFound"=>"Pulmonary Tuberculosis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M12515", "ConditionBrowseLeafName"=>"Opportunistic Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M19100", "ConditionBrowseLeafName"=>"AIDS-Related Opportunistic Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11809", "ConditionBrowseLeafName"=>"Mycobacterium Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4412", "ConditionBrowseLeafName"=>"Bacterial Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18942", "ConditionBrowseLeafName"=>"Gram-Positive Bacterial Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11826", "ConditionBrowseLeafName"=>"Mycoses", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4411", "ConditionBrowseLeafName"=>"Bacterial Infections and Mycoses", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14668", "ConditionBrowseLeafName"=>"Respiratory Tract Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10858", "ConditionBrowseLeafName"=>"Lung Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14667", "ConditionBrowseLeafName"=>"Respiratory Tract 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"}, {"ConditionBrowseBranchName"=>"Respiratory Tract (Lung and Bronchial) Diseases", "ConditionBrowseBranchAbbrev"=>"BC08"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000011736", "InterventionMeshTerm"=>"Pyridoxine"}, {"InterventionMeshId"=>"D000025101", "InterventionMeshTerm"=>"Vitamin B 6"}, {"InterventionMeshId"=>"D000064704", "InterventionMeshTerm"=>"Levofloxacin"}, {"InterventionMeshId"=>"D000007538", "InterventionMeshTerm"=>"Isoniazid"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000892", "InterventionAncestorTerm"=>"Anti-Infective Agents, Urinary"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"InterventionAncestorId"=>"D000000900", "InterventionAncestorTerm"=>"Anti-Bacterial Agents"}, {"InterventionAncestorId"=>"D000059005", "InterventionAncestorTerm"=>"Topoisomerase II Inhibitors"}, {"InterventionAncestorId"=>"D000059003", "InterventionAncestorTerm"=>"Topoisomerase Inhibitors"}, {"InterventionAncestorId"=>"D000004791", "InterventionAncestorTerm"=>"Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000000970", "InterventionAncestorTerm"=>"Antineoplastic Agents"}, {"InterventionAncestorId"=>"D000065609", "InterventionAncestorTerm"=>"Cytochrome P-450 CYP1A2 Inhibitors"}, {"InterventionAncestorId"=>"D000065607", "InterventionAncestorTerm"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000000995", "InterventionAncestorTerm"=>"Antitubercular Agents"}, {"InterventionAncestorId"=>"D000054872", "InterventionAncestorTerm"=>"Fatty Acid Synthesis Inhibitors"}, {"InterventionAncestorId"=>"D000000960", "InterventionAncestorTerm"=>"Hypolipidemic Agents"}, {"InterventionAncestorId"=>"D000000963", "InterventionAncestorTerm"=>"Antimetabolites"}, {"InterventionAncestorId"=>"D000057847", "InterventionAncestorTerm"=>"Lipid Regulating Agents"}, {"InterventionAncestorId"=>"D000014803", "InterventionAncestorTerm"=>"Vitamin B Complex"}, {"InterventionAncestorId"=>"D000014815", "InterventionAncestorTerm"=>"Vitamins"}, {"InterventionAncestorId"=>"D000018977", "InterventionAncestorTerm"=>"Micronutrients"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M10260", "InterventionBrowseLeafName"=>"Isoniazid", "InterventionBrowseLeafAsFound"=>"Stomach", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M30060", "InterventionBrowseLeafName"=>"Levofloxacin", "InterventionBrowseLeafAsFound"=>"Fixation", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M14279", "InterventionBrowseLeafName"=>"Pyridoxine", "InterventionBrowseLeafAsFound"=>"Fermentation", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M14273", "InterventionBrowseLeafName"=>"Pyridoxal", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M22716", "InterventionBrowseLeafName"=>"Vitamin B 6", "InterventionBrowseLeafAsFound"=>"Fermentation", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M17636", "InterventionBrowseLeafName"=>"Ofloxacin", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17248", "InterventionBrowseLeafName"=>"Vitamins", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17236", "InterventionBrowseLeafName"=>"Vitamin B Complex", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3904", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3912", "InterventionBrowseLeafName"=>"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7641", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M30227", "InterventionBrowseLeafName"=>"Cytochrome P-450 Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4001", "InterventionBrowseLeafName"=>"Antitubercular Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3968", "InterventionBrowseLeafName"=>"Hypolipidemic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3971", "InterventionBrowseLeafName"=>"Antimetabolites", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M28573", "InterventionBrowseLeafName"=>"Lipid Regulating Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M8308", "InterventionBrowseLeafName"=>"Folic Acid", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20699", "InterventionBrowseLeafName"=>"Micronutrients", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M16575", "InterventionBrowseLeafName"=>"Trace Elements", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T461", "InterventionBrowseLeafName"=>"Pyridoxine", "InterventionBrowseLeafAsFound"=>"Protease Inhibitors", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"T459", "InterventionBrowseLeafName"=>"Pyridoxal", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T474", "InterventionBrowseLeafName"=>"Vitamin B6", "InterventionBrowseLeafAsFound"=>"Fermentation", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"T446", "InterventionBrowseLeafName"=>"Folic Acid", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T448", "InterventionBrowseLeafName"=>"Folate", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T475", "InterventionBrowseLeafName"=>"Vitamin B9", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"Lipid Regulating Agents", "InterventionBrowseBranchAbbrev"=>"Lipd"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"Micronutrients", "InterventionBrowseBranchAbbrev"=>"Micro"}, {"InterventionBrowseBranchName"=>"Hematinics", "InterventionBrowseBranchAbbrev"=>"Hemat"}, {"InterventionBrowseBranchName"=>"Vitamins", "InterventionBrowseBranchAbbrev"=>"Vi"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"44"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"June 1995", "LastUpdateSubmitDate"=>"August 6, 2008", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"August 30, 2001", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"August 8, 2008", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"August 31, 2001", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Isoniazid", "Tuberculosis, Pulmonary", "Pyridoxine", "Ofloxacin", "AIDS-Related Opportunistic Infections", "Drug Evaluation", "Acquired Immunodeficiency Syndrome", "Sputum", "Colony Count, Microbial"]}, "ConditionList"=>{"Condition"=>["HIV Infections", "Tuberculosis"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferenceType"=>"background", "ReferenceCitation"=>"El-Sadr WM, Perlman DC, Matts JP, Nelson E, Cohn D, Telzak E, Chirgwin K, Salomon N, Olibrice M, Hafner R. Outcome of an induction regimen for the treatment of HIV-related tuberculosis (TB): evaluation of the addition of a quinolone. Int Conf AIDS. 1996 Jul 7-12;11(1):327 (abstract no TuB2358)"}]}}, "DescriptionModule"=>{"BriefSummary"=>"To evaluate the methodology for rapidly determining the early bactericidal activity (EBA), tolerance, and pharmacokinetics of isoniazid and levofloxacin in the treatment of pulmonary tuberculosis (TB).\n\nTraditionally, in trials for treatment of TB, a new drug is administered in combination with two or more other antituberculous agents of known effectiveness over a long period of time. In this setting, it is difficult to determine the effect of any single drug or dose level. Development of new agents for the treatment of TB may be accelerated by a methodology in which a new agent could be evaluated for activity by administering it as a single agent over a short time period. This study utilizes a method to measure the amount of bacteria present each day in the lungs.", "DetailedDescription"=>"Traditionally, in trials for treatment of TB, a new drug is administered in combination with two or more other antituberculous agents of known effectiveness over a long period of time. In this setting, it is difficult to determine the effect of any single drug or dose level. Development of new agents for the treatment of TB may be accelerated by a methodology in which a new agent could be evaluated for activity by administering it as a single agent over a short time period. This study utilizes a method to measure the amount of bacteria present each day in the lungs.\n\nAn initial cohort of patients receive isoniazid (with pyridoxine) daily for 5 days. Sputum samples are collected daily for determination of the EBA (decline in colony-forming units/ml sputum). If the methodology is validated, additional patients are randomized to receive one of two doses of levofloxacin daily for 5 days, with determination of EBA. All patients are hospitalized for 2 days of baseline evaluation and 5 days of treatment."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed in all patients:\n\nAntacids if administered more than 2 hours before or after study drug.\n\nAllowed in isoniazid patients:\n\nAnticonvulsant therapy if blood levels are monitored.\n\nAllowed in levofloxacin patients:\n\nAcceptable medications other than antacids if administered at least 2 hours before or 1 hour after study drug.\nAnticonvulsant therapy, theophylline, or warfarin if doses are monitored.\n\nPatients must have:\n\nPresumptive active pulmonary TB.\nNo clinical evidence of central nervous system or miliary tuberculosis.\n\nNOTE:\n\nBoth HIV-positive and HIV-negative patients are eligible.\n\nNOTE:\n\nPregnant women may be enrolled in the isoniazid cohort only.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\nActive or suspected MAI infection.\nActive or suspected hepatitis.\nAny other serious acute infection, diabetes, chronic obstructive pulmonary disease, malignancy requiring chemotherapy, or major organ dysfunction.\nExtreme illness or toxic appearance.\nPregnancy (if entering the levofloxacin portion of the study).\n\nConcurrent Medication:\n\nExcluded:\n\nAll standard TB therapies.\nClofazimine.\nRifabutin.\nQuinolones.\nAminoglycosides.\nCorticosteroids.\nPentoxifylline.\nColony-stimulating factors.\nInterferons.\nInterleukins.\nDisulfiram (patients receiving isoniazid).\n\nPatients with the following prior conditions are excluded:\n\nHistory of treatment-limiting intolerance or known hypersensitivity to isoniazid (in patients receiving isoniazid) or to quinolones (in patients receiving levofloxacin).\nVomiting or diarrhea >= grade 2 at screening or within 2 days prior to screening.\nHistory of drug-resistant TB (in patients receiving isoniazid).\n\nPrior Medication:\n\nExcluded:\n\nAny prior treatment or prophylaxis for TB if enrolling on the isoniazid cohort.\nAny anti-TB drug within the past 12 weeks, including standard drugs against TB as well as clofazimine, rifabutin, and all quinolones and aminoglycosides.\nCorticosteroids, pentoxifylline, colony-stimulating factors, interferons, or interleukins within the past 12 weeks.\n\nKnown risk factors for multi-drug resistant (MDR) TB, including:\n\nDomicile, shelter, or prison exposure to a known case of MDR TB within the past 6 months.\nResidence in a specific domicile, shelter, or prison cell block within 6 months of a known outbreak of MDR TB.\nHospitalization, within the past 6 months, on a medical service or unit in which nosocomial transmission of MDR TB is known to have occurred."}, "IdentificationModule"=>{"NCTId"=>"NCT00000778", "BriefTitle"=>"A Pilot Study of Methodology to Rapidly Evaluate Drugs for Bactericidal Activity, Tolerance, and Pharmacokinetics in the Treatment of Pulmonary Tuberculosis Using Isoniazid and Levofloxacin", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"A Pilot Study of Methodology to Rapidly Evaluate Drugs for Bactericidal Activity, Tolerance, and Pharmacokinetics in the Treatment of Pulmonary Tuberculosis Using Isoniazid and Levofloxacin", "OrgStudyIdInfo"=>{"OrgStudyId"=>"DATRI 008"}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Isoniazid", "InterventionType"=>"Drug"}, {"InterventionName"=>"Pyridoxine hydrochloride", "InterventionType"=>"Drug"}, {"InterventionName"=>"Levofloxacin", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"352336505", "LocationCity"=>"Birmingham", "LocationState"=>"Alabama", "LocationCountry"=>"United States", "LocationFacility"=>"Univ of Alabama at Birmingham"}, {"LocationZip"=>"900951793", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"UCLA Med Ctr"}, {"LocationZip"=>"90502", "LocationCity"=>"Torrance", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Harbor - UCLA Med Ctr"}, {"LocationZip"=>"33316", "LocationCity"=>"Fort Lauderdale", "LocationState"=>"Florida", "LocationCountry"=>"United States", "LocationFacility"=>"Broward Gen Med Ctr"}, {"LocationZip"=>"33136", "LocationCity"=>"Miami", "LocationState"=>"Florida", "LocationCountry"=>"United States", "LocationFacility"=>"Univ of Miami / Jackson Memorial Hosp"}, {"LocationZip"=>"60622", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"Univ of Illinois"}, {"LocationZip"=>"701122699", "LocationCity"=>"New Orleans", "LocationState"=>"Louisiana", "LocationCountry"=>"United States", "LocationFacility"=>"Tulane Univ Med School"}, {"LocationZip"=>"75235", "LocationCity"=>"Dallas", "LocationState"=>"Texas", "LocationCountry"=>"United States", "LocationFacility"=>"Univ of Texas Southwestern Med Ctr of Dallas"}, {"LocationZip"=>"77550", "LocationCity"=>"Galveston", "LocationState"=>"Texas", "LocationCountry"=>"United States", "LocationFacility"=>"Univ TX Galveston"}, {"LocationZip"=>"77030", "LocationCity"=>"Houston", "LocationState"=>"Texas", "LocationCountry"=>"United States", "LocationFacility"=>"Baylor College of Medicine / Houston Veterans Adm Med Ctr"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Hafner R", "OverallOfficialRole"=>"Study Chair"}, {"OverallOfficialName"=>"Cohn J", "OverallOfficialRole"=>"Study Chair"}, {"OverallOfficialName"=>"Egorin M", "OverallOfficialRole"=>"Study Chair"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}}}}}}