The Safety and Effectiveness of Adefovir Dipivoxil in the Treatment of HIV-Infected Patients

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Nctid: NCT00001082

Payload: {"FullStudy"=>{"Rank"=>498251, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000007239", "ConditionMeshTerm"=>"Infections"}, {"ConditionMeshId"=>"D000003141", "ConditionMeshTerm"=>"Communicable Diseases"}, {"ConditionMeshId"=>"D000003586", "ConditionMeshTerm"=>"Cytomegalovirus Infections"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000020969", "ConditionAncestorTerm"=>"Disease Attributes"}, {"ConditionAncestorId"=>"D000010335", "ConditionAncestorTerm"=>"Pathologic Processes"}, {"ConditionAncestorId"=>"D000014777", "ConditionAncestorTerm"=>"Virus Diseases"}, {"ConditionAncestorId"=>"D000006566", "ConditionAncestorTerm"=>"Herpesviridae Infections"}, {"ConditionAncestorId"=>"D000004266", "ConditionAncestorTerm"=>"DNA Virus Infections"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M10283", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafAsFound"=>"Infection", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M6368", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafAsFound"=>"Infection", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M3522", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18250", "ConditionBrowseLeafName"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6791", "ConditionBrowseLeafName"=>"Cytomegalovirus Infections", "ConditionBrowseLeafAsFound"=>"Cytomegalovirus Infections", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M22700", "ConditionBrowseLeafName"=>"Disease Attributes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17522", "ConditionBrowseLeafName"=>"Virus Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9643", "ConditionBrowseLeafName"=>"Herpesviridae Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7442", "ConditionBrowseLeafName"=>"DNA Virus Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T1720", "ConditionBrowseLeafName"=>"Cytomegalic Inclusion Disease", "ConditionBrowseLeafAsFound"=>"Cytomegalovirus Infections", "ConditionBrowseLeafRelevance"=>"high"}]}, "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"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"C000053001", "InterventionMeshTerm"=>"Adefovir"}, {"InterventionMeshId"=>"C000106812", "InterventionMeshTerm"=>"Adefovir dipivoxil"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000998", "InterventionAncestorTerm"=>"Antiviral Agents"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"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"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M4314", "InterventionBrowseLeafName"=>"Antiviral Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M219518", "InterventionBrowseLeafName"=>"Adefovir", "InterventionBrowseLeafAsFound"=>"Laryngoscope", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M341402", "InterventionBrowseLeafName"=>"Adefovir dipivoxil", "InterventionBrowseLeafAsFound"=>"IGF-", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M4214", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20935", "InterventionBrowseLeafName"=>"Reverse Transcriptase Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7951", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T372", "InterventionBrowseLeafName"=>"Carnitine", "InterventionBrowseLeafAsFound"=>"Pass", "InterventionBrowseLeafRelevance"=>"high"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Other Dietary Supplements", "InterventionBrowseBranchAbbrev"=>"Ot"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 3"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"Double", "DesignWhoMaskedList"=>{"DesignWhoMasked"=>["Participant", "Care Provider"]}}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Parallel Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"505"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"December 1996"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"September 2013", "CompletionDateStruct"=>{"CompletionDate"=>"August 1999", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"September 28, 2013", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"August 30, 2001", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"October 1, 2013", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"August 31, 2001", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"January 1999", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Morbidity", "PrimaryOutcomeTimeFrame"=>"Throughout study"}]}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Cytomegalovirus Infections", "Antiviral Agents", "CD4 Lymphocyte Count", "Prodrugs", "Survival", "Adenine"]}, "ConditionList"=>{"Condition"=>["Cytomegalovirus Infections", "HIV Infections"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferenceType"=>"background", "ReferenceCitation"=>"Fisher E, Brosgart C, Cohn D, Chaloner K, Pulling C, Alston B, Schmetter B, El-Sadr W. Placebo (PLC)-controlled, multicenter trial of adefovir dipivoxil (ADV) in patients (pt) with HIV disease. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:160 (abstract no 491)"}, {"ReferenceType"=>"background", "ReferenceCitation"=>"Brosgart C, Fisher E, Pulling C, Chaloner K, Cohn D, Elsadr W, Verheggen R, Schmetter B, Alston B. Prevalence of asymptomatic CMV retinitis (CMVR) in AIDS patients. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:152 (abstract no 453)"}, {"ReferenceType"=>"background", "ReferenceCitation"=>"Fisher E, Brosgart C, Cohn D, Chaloner K, Pulling C, Schmetter B, Alston B, El-Sadr W. Safety of adefovir dipivoxil (ADV) and incidence of proximal renal tubular disorder (PRTD) in a placebo (PLC)-controlled trial in patients (pt) with advanced HIV disease. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:195 (abstract no 678)"}, {"ReferenceType"=>"background", "ReferenceCitation"=>"Brosgart C, Pulling C, Chaloner K, Fisher E, Coakley D, Diggins M, Ivannidis J. Serum carnitine levels in AIDS patients with advanced HIV disease from the CPCRA 039 trial. Int Conf AIDS. 1998;12:1094 (abstract no 60508)"}]}}, "DescriptionModule"=>{"BriefSummary"=>"To evaluate the safety and efficacy of adefovir dipivoxil in prolonging survival of patients with advanced HIV disease. In CMV prophylaxis substudy: To evaluate the efficacy of adefovir dipivoxil in preventing the development of CMV end-organ disease in patients with advanced HIV coinfected with CMV.\n\nThe optimal treatment for HIV infection and the prevention of CMV disease has not been identified. Currently available antiretroviral therapies are hampered by both significant toxicities and the development of resistance. In addition, agents for preventing CMV disease, such as oral ganciclovir, are complicated by poor bioavailability and decreased compliance secondary to toxicities. Moreover, discordant results have been reported regarding the effectiveness of oral ganciclovir for preventing CMV disease. There is a need for newer agents with anti-HIV and anti-herpesvirus activity that have good pharmacokinetic and safety profiles and that will be well tolerated by patients. Adefovir dipivoxil is an oral pro-drug of PMEA, a nucleoside analog with activity against a broad spectrum of retroviruses and herpesviruses, including important human pathogens, such as HIV-1, HIV-2 and CMV. Due to its anti-HIV and anti-herpesvirus activity, adefovir dipivoxil may be able to decrease the incidence of opportunistic herpesvirus infections and prolong survival in patients with advanced HIV infection.", "DetailedDescription"=>"The optimal treatment for HIV infection and the prevention of CMV disease has not been identified. Currently available antiretroviral therapies are hampered by both significant toxicities and the development of resistance. In addition, agents for preventing CMV disease, such as oral ganciclovir, are complicated by poor bioavailability and decreased compliance secondary to toxicities. Moreover, discordant results have been reported regarding the effectiveness of oral ganciclovir for preventing CMV disease. There is a need for newer agents with anti-HIV and anti-herpesvirus activity that have good pharmacokinetic and safety profiles and that will be well tolerated by patients. Adefovir dipivoxil is an oral pro-drug of PMEA, a nucleoside analog with activity against a broad spectrum of retroviruses and herpesviruses, including important human pathogens, such as HIV-1, HIV-2 and CMV. Due to its anti-HIV and anti-herpesvirus activity, adefovir dipivoxil may be able to decrease the incidence of opportunistic herpesvirus infections and prolong survival in patients with advanced HIV infection.\n\nAll patients will be enrolled within the first 18 months of the study. They will be randomized to 1 of 2 groups. Group 1 will be comprised of 1080 patients and will receive adefovir dipivoxil plus L-carnitine and group 2 will be comprised of 1080 patients and will receive a placebo plus L-carnitine. At least the first 400 patients enrolled (200 in each group) will comprise the safety-HIV virology cohort. These patients will have more frequent follow up visits, additional laboratory evaluations, and more intensive safety data information during the first 6 months. NOTE: At least 850 patients who are infected with CMV are followed for the development of CMV end-organ disease in a CMV prophylaxis substudy.\n\nAS PER AMENDMENT 8/7/97: All patients are enrolled in the primary study and randomized to the treatment or placebo regimen. Within the primary study, patients meeting specified criteria may be enrolled in one or more of the following cohorts:\n\nSafety-HIV virology cohort (at least the first 400 patients enrolled in the study regardless of CMV status).\nCMV bDNA cohort (those patients in the safety-HIV virology cohort who are CMV-positive).\nCMV-virology cohort (the first 400 patients in the CMV bDNA cohort enrolled at sites able to obtain CMV urine cultures).\n\nAll patients who are CMV-positive are enrolled in the CMV prophylaxis substudy."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"13 years", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\nChronically administered concomitant therapies for HIV and opportunistic diseases, including chemotherapy for cutaneous Kaposi's sarcoma, must be on these therapies for at least 30 days prior to study entry.\nShort courses of oral antibiotics or other therapies given for a limited period of 3 weeks.\nEpisodic use of IV acyclovir or oral acyclovir > 1g/day for treatment of acute illness is permitted at the clinician's discretion.\n\nPatients must have:\n\nA working diagnosis of HIV infection based on the patient's medical history, behavioral history, clinical signs and symptoms, or results of other laboratory tests.\nCD4+ cell count <= 100 cells/mm3 within 60 days prior to randomization (OR, AS PER AMENDMENT 8/7/97, a CD4+ cell count that is both > 100 and <= 200 cells/mm3 within 60 days prior to randomization and a documented nadir CD4+ cell count <= 50 cells/ mm3 at any time prior to randomization).\nReasonably good health.\nLife expectancy of at least 6 months.\nAccess to a refrigerator for the storage of adefovir dipivoxil.\nSigned informed consent from parent or legal guardian for patients less than 18 years of age.\n\nAS PER AMENDMENT 8/7/97:\n\nCMV serology (IgG) positive (CMV bDNA cohort and CMV-virology cohort).\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms and conditions are excluded:\n\nEvidence of active CMV disease at screening.\nConditions that would require use of medications listed in Exclusion Concurrent Medications.\n\nConcurrent Medication:\n\nExcluded:\n\nAny investigational anti-CMV agent.\nAdenine arabinoside (vidarabine).\nAmantadine hydrochloride (Symmetrel).\nCidofovir (Vistide).\nCMV hyperimmune globulin.\nCytosine arabinoside (cytarabine).\nFamciclovir.\nFoscarnet (phosphonoformic acid).\nGanciclovir (Cytovene).\nGW 1263W94 (Benzamidazole).\nIdoxuridine.\nIntravenous acyclovir.\nISIS 2922 (Anti-sense).\nLobucavir.\nMSL109.\nOral acyclovir > 1 g/day.\nValacyclovir.\n\nPatients with the following prior conditions are excluded:\n\nHistory of CMV end-organ disease.\n\nPrior Medication:\n\nExcluded within 2 weeks of randomization:\n\nAny investigational anti-CMV agent.\nAdenine arabinoside (vidarabine).\nAmantadine hydrochloride (Symmetrel).\nCidofovir (Vistide).\nCMV hyperimmune globulin.\nCytosine arabinoside (cytarabine).\nFamciclovir.\nGanciclovir (Cytovene).\nGW 1263W94 (Benzamidazole).\nIdoxuridine.\nIntravenous acyclovir.\nISIS 2922 (Anti-sense).\nLobucavir.\nMSL109.\nOral acyclovir > 1 g/day.\nValacyclovir.\n\nExcluded within 60 days prior to study entry:\n\nFoscarnet."}, "IdentificationModule"=>{"NCTId"=>"NCT00001082", "BriefTitle"=>"The Safety and Effectiveness of Adefovir Dipivoxil in the Treatment of HIV-Infected Patients", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Adefovir Dipivoxil (Bis-POM PMEA) in Prolonging Survival of HIV-Infected Individuals With a CD4+ Cell Count of <= 100/mm3 or With a CD4+ Cell Count Both > 100 and <= 200/mm3 and a Nadir CD4+ Cell Count of <= 50/mm3", "OrgStudyIdInfo"=>{"OrgStudyId"=>"CPCRA 039"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"11589", "SecondaryIdType"=>"Registry Identifier", "SecondaryIdDomain"=>"DAIDS ES"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"1", "ArmGroupDescription"=>"Participants will receive adefovir dipivoxil and L-carnitine", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Levocarnitine", "Drug: Adefovir dipivoxil"]}}, {"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"2", "ArmGroupDescription"=>"Participants will receive adefovir dipivoxil placebo and L-carnitine.", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Levocarnitine", "Drug: Adefovir dipivoxil placebo"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Levocarnitine", "InterventionType"=>"Drug", "InterventionDescription"=>"500 mg tablet taken orally daily", "InterventionOtherNameList"=>{"InterventionOtherName"=>["L-carnitine"]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["1", "2"]}}, {"InterventionName"=>"Adefovir dipivoxil", "InterventionType"=>"Drug", "InterventionDescription"=>"120 mg tablet taken orally daily", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["1"]}}, {"InterventionName"=>"Adefovir dipivoxil placebo", "InterventionType"=>"Drug", "InterventionDescription"=>"Oral placebo tablet taken daily", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["2"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"94110", "LocationCity"=>"San Francisco", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Community Consortium / UCSF"}, {"LocationZip"=>"80204", "LocationCity"=>"Denver", "LocationState"=>"Colorado", "LocationCountry"=>"United States", "LocationFacility"=>"Denver CPCRA / Denver Public Hlth"}, {"LocationZip"=>"20422", "LocationCity"=>"Washington", "LocationState"=>"District of Columbia", "LocationCountry"=>"United States", "LocationFacility"=>"Washington Reg AIDS Prog / Dept of Infect Dis"}, {"LocationZip"=>"30308", "LocationCity"=>"Atlanta", "LocationState"=>"Georgia", "LocationCountry"=>"United States", "LocationFacility"=>"AIDS Research Consortium of Atlanta"}, {"LocationZip"=>"60657", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"AIDS Research Alliance - Chicago"}, {"LocationZip"=>"70112", "LocationCity"=>"New Orleans", "LocationState"=>"Louisiana", "LocationCountry"=>"United States", "LocationFacility"=>"Louisiana Comm AIDS Rsch Prog / Tulane Univ Med"}, {"LocationZip"=>"48201", "LocationCity"=>"Detroit", "LocationState"=>"Michigan", "LocationCountry"=>"United States", "LocationFacility"=>"Wayne State Univ - WSU/DMC / Univ Hlth Ctr"}, {"LocationZip"=>"48202", "LocationCity"=>"Detroit", "LocationState"=>"Michigan", "LocationCountry"=>"United States", "LocationFacility"=>"Henry Ford Hosp"}, {"LocationZip"=>"08103", "LocationCity"=>"Camden", "LocationState"=>"New Jersey", "LocationCountry"=>"United States", "LocationFacility"=>"Southern New Jersey AIDS Cln Trials / Dept of Med"}, {"LocationZip"=>"07103", "LocationCity"=>"Newark", "LocationState"=>"New Jersey", "LocationCountry"=>"United States", "LocationFacility"=>"North Jersey Community Research Initiative"}, {"LocationZip"=>"87131", "LocationCity"=>"Albuquerque", "LocationState"=>"New Mexico", "LocationCountry"=>"United States", "LocationFacility"=>"Partners in Research / New Mexico"}, {"LocationZip"=>"10037", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Harlem AIDS Treatment Grp / Harlem Hosp Ctr"}, {"LocationZip"=>"97210", "LocationCity"=>"Portland", "LocationState"=>"Oregon", "LocationCountry"=>"United States", "LocationFacility"=>"The Research and Education Group"}, {"LocationZip"=>"19107", "LocationCity"=>"Philadelphia", "LocationState"=>"Pennsylvania", "LocationCountry"=>"United States", "LocationFacility"=>"Philadelphia FIGHT"}, {"LocationZip"=>"23298", "LocationCity"=>"Richmond", "LocationState"=>"Virginia", "LocationCountry"=>"United States", "LocationFacility"=>"Richmond AIDS Consortium / Div of Infect Diseases"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Brosgart C", "OverallOfficialRole"=>"Study Chair"}, {"OverallOfficialName"=>"Fisher E", "OverallOfficialRole"=>"Study Chair"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}