Nctid:
NCT00001045
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D015658", "term"=>"HIV Infections"}], "ancestors"=>[{"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D007239", "term"=>"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"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"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"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D015215", "term"=>"Zidovudine"}, {"id"=>"D019829", "term"=>"Nevirapine"}, {"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"}, {"id"=>"D065701", "term"=>"Cytochrome P-450 CYP3A Inducers"}, {"id"=>"D065693", "term"=>"Cytochrome P-450 Enzyme Inducers"}], "browseLeaves"=>[{"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}, {"id"=>"M17920", "name"=>"Zidovudine", "asFound"=>"Corticosteroid", "relevance"=>"HIGH"}, {"id"=>"M21717", "name"=>"Nevirapine", "asFound"=>"Restricted", "relevance"=>"HIGH"}, {"id"=>"M18548", "name"=>"Didanosine", "asFound"=>"Circulation", "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"=>"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"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>300}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1998-10", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-28", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-11-04", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Didanosine", "Drug Therapy, Combination", "Zidovudine", "Nevirapine"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Slade DE, Vavro CL, Stapleton JT, Swack N, StClair MH. A novel mutation at codon 215 of HIV RT. Int Conf AIDS. 1993 Jun 6-11;9(1):239 (abstract no PO-A26-0625)"}, {"type"=>"BACKGROUND", "citation"=>"Mayers D, Merigan T, Gilbert P. T215Y/F mutation associated with zidovudine (ZDV) resistance leads to poor response to ZDV+ddI or ZDV+ddI+NVP: ACTG244/RV79. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:91 (abstract no 129)"}, {"pmid"=>"8843229", "type"=>"BACKGROUND", "citation"=>"Holodniy M, Katzenstein D, Mole L, Winters M, Merigan T. Human immunodeficiency virus reverse transcriptase codon 215 mutations diminish virologic response to didanosine-zidovudine therapy in subjects with non-syncytium-inducing phenotype. J Infect Dis. 1996 Oct;174(4):854-7. doi: 10.1093/infdis/174.4.854."}]}, "descriptionModule"=>{"briefSummary"=>"To validate that the alteration of codon 215 of reverse transcriptase in plasma virus precedes the increase in viral burden as measured in the peripheral blood and the decline in CD4 count that have been observed in association with clinical failure on zidovudine (AZT). To determine whether alternative regimens of antiretroviral agents alter the course of viral burden as measured in the peripheral blood and CD4 changes in patients with HIV infection. To obtain further data on the safety and immunologic and virologic response to AZT/didanosine/nevirapine.\n\nOf the HIV-1 mutations reported to be associated with zidovudine resistance, the mutation at codon 215 of the reverse transcriptase gene is the most commonly occurring and has the greatest impact on susceptibility. When this mutation appears, a change in drugs may prevent further immunologic and virologic deterioration.", "detailedDescription"=>"Of the HIV-1 mutations reported to be associated with zidovudine resistance, the mutation at codon 215 of the reverse transcriptase gene is the most commonly occurring and has the greatest impact on susceptibility. When this mutation appears, a change in drugs may prevent further immunologic and virologic deterioration.\n\nInitially, all patients receive AZT alone. After detection of a 215 mutation in plasma RNA, patients are randomized to one of three treatment arms: AZT alone, AZT plus ddI, or AZT/ddI plus nevirapine. Patients are followed every 8 weeks and receive treatment for up to 4 years.\n\nAS PER AMENDMENT 5/9/96: All AZT monotherapy options have been eliminated. Patients will be randomized to either Arm II or Arm III, regardless of their codon 215 status. All patients who were randomized to Arm I following a mutation at codon 215 will be rerandomized to Arm II or Arm III. All patients who were randomized to either Arm II or Arm III following a mutation at codon 215 will remain on their initial randomized assignment."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"13 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Chemoprophylaxis for Pneumocystis carinii pneumonia.\n* Antibiotics, antifungals, and antiviral medications, as clinically indicated.\n* Regularly prescribed medication such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives, or any other medications deemed appropriate by the primary care provider.\n\nConcurrent Treatment:\n\nAllowed:\n\n* Limited localized radiation therapy to the skin.\n\nPrior Medication: Required:\n\n* AZT (minimum 300 mg/day) for at least 1 month (uninterrupted) but no more than 2 years immediately prior to study entry.\n\nPatients must have:\n\n* Asymptomatic HIV infection.\n* CD4 count 300-600 cells/mm3.\n* No plasma/serum PCR for codon 215 mutation at screening.\n* Prior AZT monotherapy.\n\nNOTE:\n\n* All Department of Defense (DOD)-eligible patients must be at least 18 years of age. Enrollment of women is encouraged.\n\nAS PER AMENDMENT 04/03/95:\n\n* DOD female patients must have a negative pregnancy test within 48 hours prior to study entry.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Symptomatic grade 2 or worse peripheral neuropathy.\n* Unable to swallow capsules and tablets.\n* Other medical condition that contraindicates study participation.\n\nConcurrent Medication:\n\nExcluded:\n\n* Systemic cytotoxic chemotherapy.\n* Biologic response modifiers (such as interferon, ampligen, or PEG-IL2).\n* Anti-HIV agents other than study drugs.\n* Other investigational agents.\n* Foscarnet unless clinically indicated for unresponsive herpes virus infection.\n* Chronic antacid or H-2 blocker use.\n* Rifampin or rifamycin class agents.\n* Antibiotics containing clavulanic acid.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Radiation therapy other than limited localized therapy to skin.\n\nPatients with the following prior condition are excluded:\n\n* History of pancreatitis.\n\nPrior Medication:\n\nExcluded:\n\n* Prior therapy with nucleoside or non-nucleoside antiretroviral agents other than AZT.\n* Immune modulating therapies (e.g., IFN-alpha, gp160) within 60 days prior to screening.\n\nPrior Treatment:\n\nExcluded:\n\n* Blood transfusion within the preceding 2 weeks.\n\nIllicit drug or alcohol abuse."}, "identificationModule"=>{"nctId"=>"NCT00001045", "briefTitle"=>"Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients With No Symptoms of the Disease", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Double-Blinded, Randomized Trial Comparing Zidovudine (AZT) Versus AZT Plus Didanosine (ddI) Versus AZT Plus ddI Plus Nevirapine in Asymptomatic Patients on AZT Monotherapy Who Develop a Mutation at Codon 215 of HIV Reverse Transcriptase in Serum/Plasma Viral RNA", "orgStudyIdInfo"=>{"id"=>"ACTG 244"}, "secondaryIdInfos"=>[{"id"=>"11221", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Nevirapine", "type"=>"DRUG"}, {"name"=>"Zidovudine", "type"=>"DRUG"}, {"name"=>"Didanosine", "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"=>"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"=>"951282699", "city"=>"San Jose", "state"=>"California", "country"=>"United States", "facility"=>"Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium", "geoPoint"=>{"lat"=>37.33939, "lon"=>-121.89496}}, {"zip"=>"943055107", "city"=>"Stanford", "state"=>"California", "country"=>"United States", "facility"=>"San Mateo AIDS Program / Stanford Univ", "geoPoint"=>{"lat"=>37.42411, "lon"=>-122.16608}}, {"zip"=>"943055107", "city"=>"Stanford", "state"=>"California", "country"=>"United States", "facility"=>"Stanford Univ Med Ctr", "geoPoint"=>{"lat"=>37.42411, "lon"=>-122.16608}}, {"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"=>"Univ of Colorado Health Sciences Ctr", "geoPoint"=>{"lat"=>39.73915, "lon"=>-104.9847}}, {"zip"=>"20007", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Georgetown Univ Med Ctr", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"200102916", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Children's Hosp of Washington DC", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"20037", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"George Washington Univ / Hershey Med Ctr", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"20307", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Walter Reed Army Med Ctr", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"30306", "city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"Emory Univ Hosp / Pediatrics", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"303652225", "city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"96816", "city"=>"Honolulu", "state"=>"Hawaii", "country"=>"United States", "facility"=>"Queens Med Ctr", 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"geoPoint"=>{"lat"=>44.94441, "lon"=>-93.09327}}, {"zip"=>"681985130", "city"=>"Omaha", "state"=>"Nebraska", "country"=>"United States", "facility"=>"Univ of Nebraska Med Ctr", "geoPoint"=>{"lat"=>41.25626, "lon"=>-95.94043}}, {"zip"=>"122083479", "city"=>"Albany", "state"=>"New York", "country"=>"United States", "facility"=>"Adirondack Med Ctr at Saranac Lake", "geoPoint"=>{"lat"=>42.65258, "lon"=>-73.75623}}, {"zip"=>"122083479", "city"=>"Albany", "state"=>"New York", "country"=>"United States", "facility"=>"Albany Med College / Division of HIV Medicine A158", "geoPoint"=>{"lat"=>42.65258, "lon"=>-73.75623}}, {"zip"=>"122083479", "city"=>"Albany", "state"=>"New York", "country"=>"United States", "facility"=>"Mid - Hudson Care Ctr", "geoPoint"=>{"lat"=>42.65258, "lon"=>-73.75623}}, {"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"=>"10461", 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"city"=>"Cleveland", "state"=>"Ohio", "country"=>"United States", "facility"=>"MetroHealth Med Ctr", "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 at Philadelphia", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"191075098", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Thomas Jefferson Univ Hosp", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"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"=>"37203", "city"=>"Nashville", "state"=>"Tennessee", "country"=>"United States", "facility"=>"Vanderbilt Univ Med Ctr", "geoPoint"=>{"lat"=>36.16589, "lon"=>-86.78444}}, {"zip"=>"775550435", "city"=>"Galveston", "state"=>"Texas", "country"=>"United States", "facility"=>"Univ of Texas Galveston", "geoPoint"=>{"lat"=>29.30135, "lon"=>-94.7977}}, {"zip"=>"782365300", "city"=>"Lackland Air Force Base", "state"=>"Texas", "country"=>"United States", "facility"=>"Wilford Hall Med Ctr", "geoPoint"=>{"lat"=>29.38663, "lon"=>-98.61797}}, {"zip"=>"78284", "city"=>"San Antonio", "state"=>"Texas", "country"=>"United States", "facility"=>"Brooke Army Med Ctr", "geoPoint"=>{"lat"=>29.42412, "lon"=>-98.49363}}, {"zip"=>"00956", "city"=>"Bayamon", "country"=>"Puerto Rico", "facility"=>"Ramon Ruiz Arnau Univ Hosp / Pediatrics", "geoPoint"=>{"lat"=>18.39856, "lon"=>-66.15572}}, {"zip"=>"009367344", "city"=>"San Juan", "country"=>"Puerto Rico", "facility"=>"San Juan City Hosp", "geoPoint"=>{"lat"=>18.46633, "lon"=>-66.10572}}], "overallOfficials"=>[{"name"=>"Merigan TC", "role"=>"STUDY_CHAIR"}, {"name"=>"Mayers DL", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Bristol-Myers Squibb", "class"=>"INDUSTRY"}, {"name"=>"Glaxo Wellcome", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
