Nctid:
NCT00000671
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D015658", "term"=>"HIV Infections"}, {"id"=>"D000163", "term"=>"Acquired Immunodeficiency Syndrome"}], "ancestors"=>[{"id"=>"D020969", "term"=>"Disease Attributes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D015229", "term"=>"Sexually Transmitted Diseases, Viral"}, {"id"=>"D012749", "term"=>"Sexually Transmitted Diseases"}, {"id"=>"D016180", "term"=>"Lentivirus Infections"}, {"id"=>"D012192", "term"=>"Retroviridae Infections"}, {"id"=>"D012327", "term"=>"RNA Virus Infections"}, {"id"=>"D014777", "term"=>"Virus Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D007153", "term"=>"Immunologic Deficiency Syndromes"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}, {"id"=>"D012897", "term"=>"Slow Virus Diseases"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "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"=>"M15700", "name"=>"Slow Virus Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D015215", "term"=>"Zidovudine"}, {"id"=>"D016049", "term"=>"Didanosine"}], "ancestors"=>[{"id"=>"D000963", "term"=>"Antimetabolites"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D019380", "term"=>"Anti-HIV Agents"}, {"id"=>"D044966", "term"=>"Anti-Retroviral Agents"}], "browseLeaves"=>[{"id"=>"M17920", "name"=>"Zidovudine", "asFound"=>"Corticosteroid", "relevance"=>"HIGH"}, {"id"=>"M18548", "name"=>"Didanosine", "asFound"=>"Hearing aid", "relevance"=>"HIGH"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}, {"id"=>"M25428", "name"=>"Anti-Retroviral Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>750}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1992-08", "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"=>"1992-03", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["Didanosine", "Zidovudine"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"7506280", "type"=>"BACKGROUND", "citation"=>"Smith MS, Koerber KL, Pagano JS. Long-term persistence of zidovudine resistance mutations in plasma isolates of human immunodeficiency virus type 1 of dideoxyinosine-treated patients removed from zidovudine therapy. J Infect Dis. 1994 Jan;169(1):184-8. doi: 10.1093/infdis/169.1.184."}, {"pmid"=>"8028406", "type"=>"BACKGROUND", "citation"=>"Bozzette SA, Hays RD, Berry SH, Kanouse DE. A Perceived Health Index for use in persons with advanced HIV disease: derivation, reliability, and validity. Med Care. 1994 Jul;32(7):716-31. doi: 10.1097/00005650-199407000-00005."}, {"pmid"=>"7712235", "type"=>"BACKGROUND", "citation"=>"Fiscus SA, Heggem-Snow A, Troiani L, Wallmark E, Folds JD, Sheff B, van der Horst CM. Transient high titers of HIV-1 in plasma and progression of disease. J Acquir Immune Defic Syndr Hum Retrovirol. 1995 May 1;9(1):51-7."}, {"pmid"=>"8843206", "type"=>"BACKGROUND", "citation"=>"Coombs RW, Welles SL, Hooper C, Reichelderfer PS, D'Aquila RT, Japour AJ, Johnson VA, Kuritzkes DR, Richman DD, Kwok S, Todd J, Jackson JB, DeGruttola V, Crumpacker CS, Kahn J. Association of plasma human immunodeficiency virus type 1 RNA level with risk of clinical progression in patients with advanced infection. AIDS Clinical Trials Group (ACTG) 116B/117 Study Team. ACTG Virology Committee Resistance and HIV-1 RNA Working Groups. J Infect Dis. 1996 Oct;174(4):704-12. doi: 10.1093/infdis/174.4.704."}, {"pmid"=>"8229656", "type"=>"BACKGROUND", "citation"=>"Richardson D, Liou SH, Kahn JO. Uric acid and didanosine compliance in AIDS clinical trials: an analysis of AIDS Clinical Trials Group protocols 116A and 116B/117. J Acquir Immune Defic Syndr (1988). 1993 Nov;6(11):1212-23."}, {"type"=>"BACKGROUND", "citation"=>"Kozal M, Winters M, Shafer R, Kroodsma K, Katzenstein D, Merigan T. Behavior of codon 74 and 215 pol gene mutations in 62 AZT experienced patients on ddI monotherapy. Natl Conf Hum Retroviruses Relat Infect (1st). 1993 Dec 12-16;55"}, {"pmid"=>"7518658", "type"=>"BACKGROUND", "citation"=>"Kozal MJ, Kroodsma K, Winters MA, Shafer RW, Efron B, Katzenstein DA, Merigan TC. Didanosine resistance in HIV-infected patients switched from zidovudine to didanosine monotherapy. Ann Intern Med. 1994 Aug 15;121(4):263-8. doi: 10.7326/0003-4819-121-4-199408150-00005."}, {"pmid"=>"8775802", "type"=>"BACKGROUND", "citation"=>"Schooley RT. Correlation between viral load measurements and outcome in clinical trials of antiviral drugs. AIDS. 1995 Dec;9 Suppl 2:S15-S19."}, {"pmid"=>"1353607", "type"=>"BACKGROUND", "citation"=>"Kahn JO, Lagakos SW, Richman DD, Cross A, Pettinelli C, Liou SH, Brown M, Volberding PA, Crumpacker CS, Beall G, et al. A controlled trial comparing continued zidovudine with didanosine in human immunodeficiency virus infection. The NIAID AIDS Clinical Trials Group. N Engl J Med. 1992 Aug 27;327(9):581-7. doi: 10.1056/NEJM199208273270901."}, {"pmid"=>"8845446", "type"=>"BACKGROUND", "citation"=>"Richman DD. Clinical significance of drug resistance in human immunodeficiency virus. Clin Infect Dis. 1995 Oct;21 Suppl 2:S166-9. doi: 10.1093/clinids/21.supplement_2.s166."}]}, "descriptionModule"=>{"briefSummary"=>"To compare the effectiveness and toxicity of didanosine (ddI) and zidovudine (AZT) in patients with AIDS or advanced AIDS-related complex (ARC) who have tolerated AZT therapy for 12 months or longer. Per amendment, asymptomatic patients with CD4 counts less than 200 cells/mm3 are eligible.\n\nAZT is effective in reducing mortality in patients with AIDS who receive the drug after the first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC. However, AZT therapy has been associated with significant toxicities. In addition, the effectiveness of AZT appears to decrease during the second and third years of therapy. For these reasons, the development of alternative therapy that would be at least as effective but less toxic is of great importance. The drug ddI is an antiviral agent that inhibits replication of HIV with less apparent toxicity than AZT. Studies indicate that ddI remains active in the body for at least 12 hours; thus benefits of ddI might be achieved with a low frequency of drug administration.", "detailedDescription"=>"AZT is effective in reducing mortality in patients with AIDS who receive the drug after the first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC. However, AZT therapy has been associated with significant toxicities. In addition, the effectiveness of AZT appears to decrease during the second and third years of therapy. For these reasons, the development of alternative therapy that would be at least as effective but less toxic is of great importance. The drug ddI is an antiviral agent that inhibits replication of HIV with less apparent toxicity than AZT. Studies indicate that ddI remains active in the body for at least 12 hours; thus benefits of ddI might be achieved with a low frequency of drug administration.\n\nTwo dose levels of ddI, each adjusted depending on patient's weight at study entry, are compared with a variable dosage regimen of AZT (the dose which the patient is tolerating at the time of study entry). Randomization is stratified by baseline CD4 cell count (less than 100 or 100-300) and Medical Center. This study continues for at least 12 months after the entry of the first subject. Patients randomized to AZT will receive orally. All patients randomized to AZT also receive a ddI placebo at 12 hour intervals. Patients randomized to ddI receive AZT placebo."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"12 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nRequired:\n\n* Aerosolized pentamidine (300 mg every 4 weeks).\n\nAllowed:\n\n* Chronic suppressive treatment for toxoplasmosis, Pneumocystis carinii pneumonia (PCP), cryptococcal meningitis, herpes simplex virus infection.\n* Ganciclovir for patients developing cytomegalovirus (CMV) infection while in study.\n* Erythropoietin for patients under the relevant treatment IND.\n* Treatment of opportunistic infections with other than sulfonamide-containing regimens.\n* Aspirin, acetaminophen, or non-steroidal anti-inflammatory agents is discouraged, but is permitted for as short a period of time as possible.\n* Chronic use of trimethoprim - sulfamethoxazole or other sulfonamide preparations is not encouraged while on study.\n\nPatients must:\n\n* Have had the diagnosis of AIDS or advanced AIDS related complex (ARC).\n* Have received AZT therapy for at least 12 months, with a minimal daily dose of 500 mg/day and with no more than 60 days off AZT therapy within the 12 month period; medical records with documentation of AZT dosing must be provided.\n* Provide informed consent (guardian as appropriate).\n* Be available for follow-up for at least 6 months.\n* Have the inclusion laboratory values within approximately 14 days of initiating therapy (except for CD4 cell counts).\n* Patients whose AIDS-defining condition is Kaposi's sarcoma alone must have CD4 cell counts \\< 300 cells/mm3.\n\nAllowed:\n\n* Positive blood culture for Mycobacterium avium or Cytomegalovirus.\n* Prior history of toxoplasmosis, Herpes simplex, Cryptococcus, or Pneumocystis carinii pneumonia (PCP) requiring chronic suppressive therapy.\n* Occasional premature atrial or ventricular contractions.\n\nPrior Medication:\n\nRequired:\n\n* Zidovudine (AZT) therapy for at least 12 months, with a minimal daily dose of 500 mg/day, and with no more than 60 days off AZT therapy within the 12-month period (documentation of AZT dosing must be provided).\n\nAllowed:\n\n* Intralesional agents.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* Psychological or emotional problems sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy.\n* AIDS-dementia complex = or \\> stage 2.\n* Active AIDS defining opportunistic infections not specifically allowed.\n* Intractable diarrhea.\n* Grade 2 neuropathy, based on the Neuropathy Targeted Symptom Questionnaire, or any moderate abnormality indicative of peripheral neuropathy, particularly impaired sensation of sharp pain, light touch, or vibration in the lower extremities, distal extremity weakness, or distal extremity hyperreflexia.\n* Prior history of acute pancreatitis within past 2 years or chronic pancreatitis.\n* History of seizures within past 2 years or currently requiring anticonvulsants for control.\n* History of past or current heart disease.\n* Malignancy likely in the investigator's opinion to require cytotoxic chemotherapy during the expected course of this trial.\n* Life expectancy \\< 3 months.\n\nConcurrent Medication:\n\nExcluded:\n\n* Isoniazid (INH). Neurotoxic drugs. Oral acidifying agents.\n\nPatients with the following are excluded:\n\n* Psychological or emotional problems sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy.\n* AIDS-dementia complex = or \\> stage 2.\n* Active AIDS defining opportunistic infections not specifically allowed.\n* Intractable diarrhea.\n* Prior history of acute pancreatitis within past 2 years or chronic pancreatitis.\n* History of seizures within past 2 years or currently requiring anticonvulsants for control.\n* History of past or current heart disease.\n* Malignancy likely in the investigator's opinion to require cytotoxic chemotherapy during the expected course of this trial.\n* Life expectancy = or \\< 3 months.\n* Previous participation in any study of ddI, ddC or d4T.\n\nPrior Medication:\n\nExcluded:\n\n* Ganciclovir (DHPG).\n* Excluded within 1 month of study entry:\n* ddI and any other antiretroviral drug or investigational anti-HIV agent except for zidovudine (AZT).\n\nInterferons.\n\n* Immunomodulating drugs.\n* Cytotoxic agents not specifically allowed.\n* Neurotoxic drugs.\n\nExcluded within 3 months of study entry:\n\n* Ribavirin.\n\nPrior Treatment:\n\nExcluded within 14 days of study randomization:\n\n* Blood transfusion.\n\nActive alcohol or drug abuse that is sufficient, in investigator's opinion, to prevent adequate compliance with study therapy."}, "identificationModule"=>{"nctId"=>"NCT00000671", "briefTitle"=>"A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment", "orgStudyIdInfo"=>{"id"=>"ACTG 117"}, "secondaryIdInfos"=>[{"id"=>"070V1"}, {"id"=>"AI454-009"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Zidovudine", "type"=>"DRUG"}, {"name"=>"Didanosine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"900276016", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Children's Hosp of Los Angeles/UCLA Med Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"90033", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Los Angeles County - USC Med Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"900481804", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Cedars Sinai / UCLA Med Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"90095", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"UCLA CARE Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"905022004", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Harbor - UCLA Med Ctr / UCLA School of Medicine", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"94304", "city"=>"Palo Alto", "state"=>"California", "country"=>"United States", "facility"=>"Palo Alto Veterans Adm Med Ctr / Stanford Univ", "geoPoint"=>{"lat"=>37.44188, "lon"=>-122.14302}}, {"zip"=>"921036325", "city"=>"San Diego", "state"=>"California", "country"=>"United States", "facility"=>"Univ of California / San Diego Treatment Ctr", "geoPoint"=>{"lat"=>32.71533, "lon"=>-117.15726}}, {"zip"=>"941102859", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"San Francisco AIDS Clinic / San Francisco Gen Hosp", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"94115", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Stanford at Kaiser / Kaiser Permanente Med Ctr", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"94305", "city"=>"Stanford", "state"=>"California", "country"=>"United States", "facility"=>"Stanford Univ School of Medicine", "geoPoint"=>{"lat"=>37.42411, "lon"=>-122.16608}}, {"zip"=>"91342", "city"=>"Sylmar", "state"=>"California", "country"=>"United States", "facility"=>"Olive View Med Ctr", "geoPoint"=>{"lat"=>34.30778, "lon"=>-118.44925}}, {"zip"=>"91342", "city"=>"Sylmar", "state"=>"California", "country"=>"United States", "facility"=>"Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr", "geoPoint"=>{"lat"=>34.30778, "lon"=>-118.44925}}, {"zip"=>"90502", "city"=>"Torrance", "state"=>"California", "country"=>"United States", "facility"=>"Harbor UCLA Med Ctr", "geoPoint"=>{"lat"=>33.83585, "lon"=>-118.34063}}, {"zip"=>"80262", "city"=>"Denver", "state"=>"Colorado", "country"=>"United States", "facility"=>"Mountain States Regional Hemophilia Ctr / Univ of Colorado", "geoPoint"=>{"lat"=>39.73915, "lon"=>-104.9847}}, {"zip"=>"80262", "city"=>"Denver", "state"=>"Colorado", "country"=>"United States", "facility"=>"Univ of Colorado Health Sciences Ctr", "geoPoint"=>{"lat"=>39.73915, "lon"=>-104.9847}}, {"zip"=>"20037", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"George Washington Univ Med Ctr", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"33316", "city"=>"Fort Lauderdale", "state"=>"Florida", "country"=>"United States", "facility"=>"G E Morey Jr", "geoPoint"=>{"lat"=>26.12231, "lon"=>-80.14338}}, {"zip"=>"331361013", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ of Miami School of Medicine", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"60611", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Northwestern Univ Med School", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Rush Presbyterian - Saint Luke's Med Ctr", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60141", "city"=>"Hines", "state"=>"Illinois", "country"=>"United States", "facility"=>"Edward Hines Veterans Administration Hosp", "geoPoint"=>{"lat"=>41.85364, "lon"=>-87.8395}}, {"zip"=>"462025250", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Indiana Univ Hosp", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"zip"=>"67214", "city"=>"Wichita", "state"=>"Kansas", "country"=>"United States", "facility"=>"Univ of Kansas School of Medicine", "geoPoint"=>{"lat"=>37.69224, "lon"=>-97.33754}}, {"zip"=>"70112", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Louisiana Comprehensive Hemophilia Care Ctr", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"70112", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Louisiana State Univ Med Ctr / Tulane Med School", "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"=>"02114", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Harvard (Massachusetts Gen Hosp)", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"02118", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Boston Med Ctr", "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"=>"02215", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Beth Israel Deaconess Med Ctr", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"01199", "city"=>"Springfield", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Baystate Med Ctr of Springfield", "geoPoint"=>{"lat"=>42.10148, "lon"=>-72.58981}}, {"zip"=>"01605", "city"=>"Worcester", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Med Ctr of Central Massachusetts", "geoPoint"=>{"lat"=>42.26259, "lon"=>-71.80229}}, {"zip"=>"01655", "city"=>"Worcester", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Univ of Massachusetts Med Ctr", "geoPoint"=>{"lat"=>42.26259, "lon"=>-71.80229}}, {"zip"=>"55455", "city"=>"Minneapolis", "state"=>"Minnesota", "country"=>"United States", "facility"=>"Univ of Minnesota", "geoPoint"=>{"lat"=>44.97997, "lon"=>-93.26384}}, {"zip"=>"68105", "city"=>"Omaha", "state"=>"Nebraska", "country"=>"United States", "facility"=>"Nebraska Regional Hemophilia Ctr", "geoPoint"=>{"lat"=>41.25626, "lon"=>-95.94043}}, {"zip"=>"10461", "city"=>"Bronx", "state"=>"New York", "country"=>"United States", "facility"=>"Bronx Municipal Hosp Ctr/Jacobi Med Ctr", "geoPoint"=>{"lat"=>40.84985, "lon"=>-73.86641}}, {"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"=>"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 Hemophilia Ctr / Mount Sinai Med 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"=>"13210", "city"=>"Syracuse", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY / State Univ of New York", "geoPoint"=>{"lat"=>43.04812, "lon"=>-76.14742}}, {"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"=>"27103", "city"=>"Winston-Salem", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Bowman Gray School of Medicine / Wake Forest Univ", "geoPoint"=>{"lat"=>36.09986, "lon"=>-80.24422}}, {"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"=>"43699", "city"=>"Toledo", "state"=>"Ohio", "country"=>"United States", "facility"=>"Med College of Ohio", "geoPoint"=>{"lat"=>41.66394, "lon"=>-83.55521}}, {"zip"=>"170330850", "city"=>"Hershey", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Milton S Hershey Med Ctr", "geoPoint"=>{"lat"=>40.28592, "lon"=>-76.65025}}, {"zip"=>"19104", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Univ of Pennsylvania", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"15219", "city"=>"Pittsburgh", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Hemophilia Ctr of Western PA / Univ of Pittsburgh", "geoPoint"=>{"lat"=>40.44062, "lon"=>-79.99589}}, {"city"=>"Pittsburgh", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Univ of Pittsburgh Med School", "geoPoint"=>{"lat"=>40.44062, "lon"=>-79.99589}}, {"zip"=>"29169", "city"=>"West Columbia", "state"=>"South Carolina", "country"=>"United States", "facility"=>"Julio Arroyo", "geoPoint"=>{"lat"=>33.99349, "lon"=>-81.07398}}, {"zip"=>"37920", "city"=>"Knoxville", "state"=>"Tennessee", "country"=>"United States", "facility"=>"Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr", "geoPoint"=>{"lat"=>35.96064, "lon"=>-83.92074}}, {"zip"=>"77030", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Hermann Hosp / Univ Texas Health Science Ctr", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"23666", "city"=>"Hampton", "state"=>"Virginia", "country"=>"United States", "facility"=>"Dr Stephen L Green", "geoPoint"=>{"lat"=>37.02987, "lon"=>-76.34522}}, {"zip"=>"98105", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"Univ of Washington", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}, {"zip"=>"53215", "city"=>"Milwaukee", "state"=>"Wisconsin", "country"=>"United States", "facility"=>"Dr Brian Buggy", "geoPoint"=>{"lat"=>43.0389, "lon"=>-87.90647}}, {"zip"=>"53226", "city"=>"Milwaukee", "state"=>"Wisconsin", "country"=>"United States", "facility"=>"Milwaukee County Med Complex", "geoPoint"=>{"lat"=>43.0389, "lon"=>-87.90647}}, {"zip"=>"53233", "city"=>"Milwaukee", "state"=>"Wisconsin", "country"=>"United States", "facility"=>"Great Lakes Hemophilia Foundation", "geoPoint"=>{"lat"=>43.0389, "lon"=>-87.90647}}, {"zip"=>"009275800", "city"=>"San Juan", "country"=>"Puerto Rico", "facility"=>"San Juan Veterans Administration Med Ctr", "geoPoint"=>{"lat"=>18.46633, "lon"=>-66.10572}}], "overallOfficials"=>[{"name"=>"J Kahn", "role"=>"STUDY_CHAIR"}, {"name"=>"D Richman", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Bristol-Myers Squibb", "class"=>"INDUSTRY"}]}}}
