Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients With AIDS

Launched by PFIZER · Aug 30, 2001

Nctid: NCT00001017

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000000163", "term"=>"Acquired Immunodeficiency Syndrome"}, {"id"=>"D000016919", "term"=>"Meningitis, Cryptococcal"}, {"id"=>"D000008581", "term"=>"Meningitis"}], "ancestors"=>[{"id"=>"D000003141", "term"=>"Communicable Diseases"}, {"id"=>"D000015658", "term"=>"HIV Infections"}, {"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D000015229", "term"=>"Sexually Transmitted Diseases, Viral"}, {"id"=>"D000012749", "term"=>"Sexually Transmitted Diseases"}, {"id"=>"D000016180", "term"=>"Lentivirus Infections"}, {"id"=>"D000012192", "term"=>"Retroviridae Infections"}, {"id"=>"D000012327", "term"=>"RNA Virus Infections"}, {"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000007153", "term"=>"Immunologic Deficiency Syndromes"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}, {"id"=>"D000090862", "term"=>"Neuroinflammatory Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000012897", "term"=>"Slow Virus Diseases"}, {"id"=>"D000016921", "term"=>"Meningitis, Fungal"}, {"id"=>"D000020314", "term"=>"Central Nervous System Fungal Infections"}, {"id"=>"D000009181", "term"=>"Mycoses"}, {"id"=>"D000001423", "term"=>"Bacterial Infections and Mycoses"}, {"id"=>"D000003453", "term"=>"Cryptococcosis"}, {"id"=>"D000002494", "term"=>"Central Nervous System Infections"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M11564", "name"=>"Meningitis", "asFound"=>"Meningitis", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "asFound"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M19263", "name"=>"Meningitis, Cryptococcal", "asFound"=>"Meningitis, Cryptococcal", "relevance"=>"HIGH"}, {"id"=>"M12825", "name"=>"Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M6664", "name"=>"Cryptococcosis", "relevance"=>"LOW"}, {"id"=>"M19410", "name"=>"AIDS-Related Opportunistic Infections", "relevance"=>"LOW"}, {"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"=>"M17522", "name"=>"Virus Diseases", "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"=>"M2803", "name"=>"Neuroinflammatory Diseases", "relevance"=>"LOW"}, {"id"=>"M15700", "name"=>"Slow Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M19265", "name"=>"Meningitis, Fungal", "relevance"=>"LOW"}, {"id"=>"M12136", "name"=>"Mycoses", "relevance"=>"LOW"}, {"id"=>"M22126", "name"=>"Central Nervous System Fungal Infections", "relevance"=>"LOW"}, {"id"=>"M4722", "name"=>"Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M4721", "name"=>"Bacterial Infections and Mycoses", "relevance"=>"LOW"}, {"id"=>"M5743", "name"=>"Central Nervous System Infections", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"T1668", "name"=>"Cryptococcosis", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000015725", "term"=>"Fluconazole"}, {"id"=>"D000000666", "term"=>"Amphotericin B"}, {"id"=>"C000068538", "term"=>"Liposomal amphotericin B"}], "ancestors"=>[{"id"=>"D000000935", "term"=>"Antifungal Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000058888", "term"=>"14-alpha Demethylase Inhibitors"}, {"id"=>"D000065607", "term"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000065088", "term"=>"Steroid Synthesis Inhibitors"}, {"id"=>"D000006727", "term"=>"Hormone Antagonists"}, {"id"=>"D000006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000065688", "term"=>"Cytochrome P-450 CYP2C9 Inhibitors"}, {"id"=>"D000065689", "term"=>"Cytochrome P-450 CYP2C19 Inhibitors"}, {"id"=>"D000000563", "term"=>"Amebicides"}, {"id"=>"D000000981", "term"=>"Antiprotozoal Agents"}, {"id"=>"D000000977", "term"=>"Antiparasitic Agents"}, {"id"=>"D000000900", "term"=>"Anti-Bacterial Agents"}], "browseLeaves"=>[{"id"=>"M4002", "name"=>"Amphotericin B", "asFound"=>"Mobile app", "relevance"=>"HIGH"}, {"id"=>"M255436", "name"=>"Liposomal amphotericin B", "asFound"=>"Mobile app", "relevance"=>"HIGH"}, {"id"=>"M18296", "name"=>"Fluconazole", "asFound"=>"5-fluorouracil", "relevance"=>"HIGH"}, {"id"=>"M6252", "name"=>"Clotrimazole", "relevance"=>"LOW"}, {"id"=>"M11796", "name"=>"Miconazole", "relevance"=>"LOW"}, {"id"=>"M4254", "name"=>"Antifungal Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M30537", "name"=>"Cytochrome P-450 Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}, {"id"=>"M3904", "name"=>"Amebicides", "relevance"=>"LOW"}, {"id"=>"M4298", "name"=>"Antiprotozoal Agents", "relevance"=>"LOW"}, {"id"=>"M4294", "name"=>"Antiparasitic Agents", "relevance"=>"LOW"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"count"=>330}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2002-09", "lastUpdateSubmitDate"=>"2011-03-11", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2011-03-14", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"1991-07", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["AIDS-Related Opportunistic Infections", "Meningitis", "Injections, Intravenous", "Cryptococcosis", "Fluconazole", "Administration, Oral", "Acquired Immunodeficiency Syndrome", "Amphotericin B"], "conditions"=>["Meningitis, Cryptococcal", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"1727236", "type"=>"BACKGROUND", "citation"=>"Saag MS, Powderly WG, Cloud GA, Robinson P, Grieco MH, Sharkey PK, Thompson SE, Sugar AM, Tuazon CU, Fisher JF, et al. Comparison of amphotericin B with fluconazole in the treatment of acute AIDS-associated cryptococcal meningitis. The NIAID Mycoses Study Group and the AIDS Clinical Trials Group. N Engl J Med. 1992 Jan 9;326(2):83-9. doi: 10.1056/NEJM199201093260202."}, {"pmid"=>"1538722", "type"=>"BACKGROUND", "citation"=>"Powderly WG, Saag MS, Cloud GA, Robinson P, Meyer RD, Jacobson JM, Graybill JR, Sugar AM, McAuliffe VJ, Follansbee SE, et al. A controlled trial of fluconazole or amphotericin B to prevent relapse of cryptococcal meningitis in patients with the acquired immunodeficiency syndrome. The NIAID AIDS Clinical Trials Group and Mycoses Study Group. N Engl J Med. 1992 Mar 19;326(12):793-8. doi: 10.1056/NEJM199203193261203."}, {"pmid"=>"8075272", "type"=>"BACKGROUND", "citation"=>"Powderly WG, Cloud GA, Dismukes WE, Saag MS. Measurement of cryptococcal antigen in serum and cerebrospinal fluid: value in the management of AIDS-associated cryptococcal meningitis. Clin Infect Dis. 1994 May;18(5):789-92. doi: 10.1093/clinids/18.5.789."}, {"pmid"=>"1672443", "type"=>"BACKGROUND", "citation"=>"McKinney RE Jr, Maha MA, Connor EM, Feinberg J, Scott GB, Wulfsohn M, McIntosh K, Borkowsky W, Modlin JF, Weintrub P, et al. A multicenter trial of oral zidovudine in children with advanced human immunodeficiency virus disease. The Protocol 043 Study Group. N Engl J Med. 1991 Apr 11;324(15):1018-25. doi: 10.1056/NEJM199104113241503."}]}, "descriptionModule"=>{"briefSummary"=>"To compare the safety and effectiveness of a new drug, fluconazole, with that of the usual therapy, amphotericin B, in the prevention of a relapse of cryptococcal meningitis (CM) in patients with AIDS who have been successfully treated for acute CM in the last 6 months.\n\nCryptococcal meningitis is a life-threatening infectious complication of AIDS. Because relapse after treatment occurs in over 50 percent of cases, chronic maintenance therapy with intravenous (IV) amphotericin B is usually given. However, amphotericin B is not always effective, has toxic effects, and must be given by the intravenous route. Fluconazole is an antifungal agent that can be given orally and has been shown to be effective against cryptococcal infections in animals and against acute CM in a few AIDS patients. Also, the side effects experienced by over 2000 patients or volunteers given fluconazole have seldom been severe enough to require withdrawal of the drug.", "detailedDescription"=>"Cryptococcal meningitis is a life-threatening infectious complication of AIDS. Because relapse after treatment occurs in over 50 percent of cases, chronic maintenance therapy with intravenous (IV) amphotericin B is usually given. However, amphotericin B is not always effective, has toxic effects, and must be given by the intravenous route. Fluconazole is an antifungal agent that can be given orally and has been shown to be effective against cryptococcal infections in animals and against acute CM in a few AIDS patients. Also, the side effects experienced by over 2000 patients or volunteers given fluconazole have seldom been severe enough to require withdrawal of the drug.\n\nPatients accepted in the trial are randomly assigned to fluconazole or amphotericin B. Fluconazole is given orally once a day and amphotericin B is given intravenously once a week. Dosages depend on body weight. Medications may be given with amphotericin B to prevent or reduce discomfort from associated side effects. Patients are treated for 12 months and may continue to receive antiviral therapy, radiation therapy for mucocutaneous Kaposi's sarcoma, or preventive therapy for Pneumocystis carinii pneumonia (PCP) during the study."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\n* HIV infection documented by antibody (ELISA on two occasions or ELISA with Western blot confirmation), p24 antigen testing, or recovery of HIV in culture.\n\nPrior Medication:\n\nRequired:\n\n* Minimum total dose of 15 mg/kg of amphotericin B (either alone or in combination with flucytosine) during primary therapy. End of primary therapy within 6 weeks of start of maintenance therapy.\n* Allowed:\n* Past or present antiviral therapy and prophylaxis for Pneumocystis carinii pneumonia (PCP).\n* Pfizer must be notified if the patient is receiving ganciclovir at entry. Allowed with amphotericin B to treat or prevent side effects.\n* Antipyretics.\n* Hydrocortisone.\n* Meperidine.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* Clinical evidence of acute or chronic meningitis other than cryptococcosis.\n* Allergy or intolerance of imidazoles, azoles, or amphotericin B. Unable to take oral medications reliably.\n\nPatients with the following are excluded:\n\n* Clinical evidence of acute or chronic meningitis other than cryptococcosis.\n* Allergy or intolerance of imidazoles, azoles, or amphotericin B.\n\nPrior Medication:\n\nExcluded for more than 7 days after initiation of primary therapy for cryptococcosis:\n\n* Ketoconazole.\n* Fluconazole.\n* Itraconazole.\n* Miconazole.\n* Any other systemic imidazole or azole.\n* Excluded:\n* Intrathecal amphotericin B.\n* Coumadin-type anticoagulants.\n* Oral hypoglycemics.\n* Barbiturates.\n* Phenytoin.\n* Immunostimulants.\n* Investigational drug or approved (licensed) drugs for investigational indications.\n\nPrior Treatment:\n\nExcluded:\n\n* Lymphocyte replacement."}, "identificationModule"=>{"nctId"=>"NCT00001017", "briefTitle"=>"Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients With AIDS", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"Comparison of Fluconazole (UK-49,858) and Amphotericin B for Maintenance Treatment of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome", "orgStudyIdInfo"=>{"id"=>"ACTG 026"}, "secondaryIdInfos"=>[{"id"=>"056-158"}, {"id"=>"FDA 12E"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Fluconazole", "type"=>"DRUG"}, {"name"=>"Amphotericin B", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90095", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"UCLA CARE Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"331361013", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ of Miami School of Medicine", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"462025250", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Indiana Univ Hosp", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"zip"=>"70112", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Louisiana State Univ School of Medicine", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"70112", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Tulane Univ School of Medicine", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"21287", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Hosp", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"02114", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Harvard (Massachusetts Gen Hosp)", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"02215", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Beth Israel Deaconess - West Campus", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"10465", "city"=>"Bronx", "state"=>"New York", "country"=>"United States", "facility"=>"Jack Weiler Hosp / Bronx Municipal Hosp", "geoPoint"=>{"lat"=>40.84985, "lon"=>-73.86641}}, {"zip"=>"10467", "city"=>"Bronx", "state"=>"New York", "country"=>"United States", "facility"=>"Montefiore Med Ctr / Bronx Municipal Hosp", "geoPoint"=>{"lat"=>40.84985, "lon"=>-73.86641}}, {"zip"=>"10467", "city"=>"Bronx", "state"=>"New York", "country"=>"United States", "facility"=>"North Central Bronx Hosp / Bronx Municipal Hosp", "geoPoint"=>{"lat"=>40.84985, "lon"=>-73.86641}}, {"zip"=>"10468", "city"=>"Bronx", "state"=>"New York", "country"=>"United States", "facility"=>"Bronx Veterans Administration / Mount Sinai Hosp", "geoPoint"=>{"lat"=>40.84985, "lon"=>-73.86641}}, {"zip"=>"14215", "city"=>"Buffalo", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY / Erie County Med Ctr at Buffalo", "geoPoint"=>{"lat"=>42.88645, "lon"=>-78.87837}}, {"zip"=>"11373", "city"=>"Elmhurst", "state"=>"New York", "country"=>"United States", "facility"=>"City Hosp Ctr at Elmhurst / Mount Sinai Hosp", "geoPoint"=>{"lat"=>40.73649, "lon"=>-73.87791}}, {"zip"=>"10003", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Beth Israel Med Ctr / Peter Krueger Clinic", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10016", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Bellevue Hosp / New York Univ Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10021", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Cornell Univ Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10021", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Mem Sloan - Kettering Cancer Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10025", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Saint Luke's - Roosevelt Hosp Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10029", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Mount Sinai Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"14642", "city"=>"Rochester", "state"=>"New York", "country"=>"United States", "facility"=>"Univ of Rochester Medical Center", "geoPoint"=>{"lat"=>43.15478, "lon"=>-77.61556}}, {"zip"=>"117948153", "city"=>"Stony Brook", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY - Stony Brook", "geoPoint"=>{"lat"=>40.92565, "lon"=>-73.14094}}, {"zip"=>"275997215", "city"=>"Chapel Hill", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Univ of North Carolina", "geoPoint"=>{"lat"=>35.9132, "lon"=>-79.05584}}, {"zip"=>"27710", "city"=>"Durham", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Duke Univ Med Ctr", "geoPoint"=>{"lat"=>35.99403, "lon"=>-78.89862}}, {"zip"=>"452670405", "city"=>"Cincinnati", "state"=>"Ohio", "country"=>"United States", "facility"=>"Holmes Hosp / Univ of Cincinnati Med Ctr", "geoPoint"=>{"lat"=>39.12713, "lon"=>-84.51435}}, {"zip"=>"44106", "city"=>"Cleveland", "state"=>"Ohio", "country"=>"United States", "facility"=>"Univ Hosp of Cleveland / Case Western Reserve Univ", "geoPoint"=>{"lat"=>41.4995, "lon"=>-81.69541}}, {"zip"=>"432101228", "city"=>"Columbus", "state"=>"Ohio", "country"=>"United States", "facility"=>"Ohio State Univ Hosp Clinic", "geoPoint"=>{"lat"=>39.96118, "lon"=>-82.99879}}, {"zip"=>"29169", "city"=>"West Columbia", "state"=>"South Carolina", "country"=>"United States", "facility"=>"Julio Arroyo", "geoPoint"=>{"lat"=>33.99349, "lon"=>-81.07398}}], "overallOfficials"=>[{"name"=>"Armstrong D", "role"=>"STUDY_CHAIR"}, {"name"=>"Dismukes W", "role"=>"STUDY_CHAIR"}, {"name"=>"Powderly W", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Pfizer", "class"=>"INDUSTRY"}, "collaborators"=>[{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}]}}}