Nctid:
NCT00002320
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "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"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"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"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M3735", "name"=>"AIDS-Related Complex", "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"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D019259", "term"=>"Lamivudine"}, {"id"=>"D015215", "term"=>"Zidovudine"}], "ancestors"=>[{"id"=>"D018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D019380", "term"=>"Anti-HIV Agents"}, {"id"=>"D044966", "term"=>"Anti-Retroviral Agents"}, {"id"=>"D000963", "term"=>"Antimetabolites"}], "browseLeaves"=>[{"id"=>"M21243", "name"=>"Lamivudine", "asFound"=>"Group A", "relevance"=>"HIGH"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M17920", "name"=>"Zidovudine", "asFound"=>"Underwent", "relevance"=>"HIGH"}, {"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "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"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>320}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1994-05", "lastUpdateSubmitDate"=>"2005-12-08", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2005-12-12", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Drug Therapy, Combination", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex", "Antiviral Agents", "Zidovudine"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"9030391", "type"=>"BACKGROUND", "citation"=>"Eron JJ Jr. The treatment of antiretroviral-naive subjects with the 3TC/zidovudine combination: a review of North American (NUCA 3001) and European (NUCB 3001) trials. AIDS. 1996 Dec;10 Suppl 5:S11-9. doi: 10.1097/00002030-199612005-00003."}, {"pmid"=>"8853730", "type"=>"BACKGROUND", "citation"=>"Kuritzkes DR, Quinn JB, Benoit SL, Shugarts DL, Griffin A, Bakhtiari M, Poticha D, Eron JJ, Fallon MA, Rubin M. Drug resistance and virologic response in NUCA 3001, a randomized trial of lamivudine (3TC) versus zidovudine (ZDV) versus ZDV plus 3TC in previously untreated patients. AIDS. 1996 Aug;10(9):975-81. doi: 10.1097/00002030-199610090-00007."}]}, "descriptionModule"=>{"briefSummary"=>"To evaluate the safety and efficacy of high-dose lamivudine (3TC) alone versus zidovudine (AZT) alone versus 3TC at high and low doses in combination with AZT in HIV-1 infected patients.\n\nPER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label combination therapy.", "detailedDescription"=>"Patients are randomized to one of four treatment arms: 3TC alone, AZT alone, low-dose 3TC plus AZT, or high-dose 3TC plus AZT. Patients receive treatment for 32 weeks, with possible extension to 52 weeks.\n\nPER 02/27/95 AMENDMENT: Patients may continue therapy on AZT and low-dose 3TC on an open-label basis. Open-label therapy continues with follow-up every 8 weeks until intolerable toxicity occurs or study terminates."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"12 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have:\n\n* HIV positivity.\n* CD4 count 200-500 cells/mm3.\n* AZT naive status (\\<= 4 weeks of prior AZT).\n\nExclusion Criteria\n\nPatients with the following prior condition are excluded:\n\nHistory of intolerance to AZT.\n\nPrior Medication:\n\nExcluded:\n\n* More than 4 weeks of prior AZT.\n* Any prior antiretroviral treatment other than AZT."}, "identificationModule"=>{"nctId"=>"NCT00002320", "briefTitle"=>"A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Randomized, Double-Blind Multicenter Trial to Compare the Safety and Efficacy of Lamivudine (3TC; GR109714X) Monotherapy Versus Zidovudine (AZT) Monotherapy Versus 3TC Administered With AZT in the Treatment of HIV-1 Infected Patients Who Are AZT Naive (< 4 Weeks) With CD4 Cell Counts of 200-500 Cells/mm3", "orgStudyIdInfo"=>{"id"=>"129B"}, "secondaryIdInfos"=>[{"id"=>"NUCA 3001"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Lamivudine", "type"=>"DRUG"}, {"name"=>"Zidovudine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90028", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Combat Group", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"92104", "city"=>"San Diego", "state"=>"California", "country"=>"United States", "facility"=>"San Diego Community Research Group", "geoPoint"=>{"lat"=>32.71533, "lon"=>-117.15726}}, {"zip"=>"91403", "city"=>"Sherman Oaks", "state"=>"California", "country"=>"United States", "facility"=>"Pacific Oaks Med Group", "geoPoint"=>{"lat"=>34.15112, "lon"=>-118.44925}}, {"zip"=>"90509", "city"=>"Torrance", "state"=>"California", "country"=>"United States", "facility"=>"Harbor - UCLA Med Ctr", "geoPoint"=>{"lat"=>33.83585, "lon"=>-118.34063}}, {"zip"=>"33614", "city"=>"Tampa", "state"=>"Florida", "country"=>"United States", "facility"=>"Infectious Disease Research Institute Inc", "geoPoint"=>{"lat"=>27.94752, "lon"=>-82.45843}}, {"zip"=>"30308", "city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"AIDS Research Consortium of Atlanta", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"60607", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Chicago Ctr for Clinical Research", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"70119", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Louisiana Cardiovascular Research Ctr", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"02445", "city"=>"Brookline", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"CRI of New England", "geoPoint"=>{"lat"=>42.33176, "lon"=>-71.12116}}, {"zip"=>"10019", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Saint Luke's - Roosevelt Hosp Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"275997215", "city"=>"Chapel Hill", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Univ of North Carolina School of Medicine", "geoPoint"=>{"lat"=>35.9132, "lon"=>-79.05584}}, {"zip"=>"43699", "city"=>"Toledo", "state"=>"Ohio", "country"=>"United States", "facility"=>"Med College of Ohio", "geoPoint"=>{"lat"=>41.66394, "lon"=>-83.55521}}, {"zip"=>"97210", "city"=>"Portland", "state"=>"Oregon", "country"=>"United States", "facility"=>"Portland Veterans Adm Med Ctr / Rsch & Education Grp", "geoPoint"=>{"lat"=>45.52345, "lon"=>-122.67621}}, {"zip"=>"02860", "city"=>"Pawtucket", "state"=>"Rhode Island", "country"=>"United States", "facility"=>"Mem Hosp of Rhode Island", "geoPoint"=>{"lat"=>41.87871, "lon"=>-71.38256}}, {"zip"=>"78751", "city"=>"Austin", "state"=>"Texas", "country"=>"United States", "facility"=>"Central Texas Med Foundation", "geoPoint"=>{"lat"=>30.26715, "lon"=>-97.74306}}, {"zip"=>"75246", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"Nicholaos Bellos", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"23219", "city"=>"Richmond", "state"=>"Virginia", "country"=>"United States", "facility"=>"Richmond AIDS Consortium", "geoPoint"=>{"lat"=>37.55376, "lon"=>-77.46026}}, {"zip"=>"53202", "city"=>"Milwaukee", "state"=>"Wisconsin", "country"=>"United States", "facility"=>"Wisconsin Community - Based Research Consortium", "geoPoint"=>{"lat"=>43.0389, "lon"=>-87.90647}}, {"city"=>"Ottawa", "state"=>"Ontario", "country"=>"Canada", "facility"=>"Ottawa General Hospital", "geoPoint"=>{"lat"=>45.41117, "lon"=>-75.69812}}, {"city"=>"Toronto", "state"=>"Ontario", "country"=>"Canada", "facility"=>"Toronto Hosp", "geoPoint"=>{"lat"=>43.70011, "lon"=>-79.4163}}, {"city"=>"Montreal", "state"=>"Quebec", "country"=>"Canada", "facility"=>"Montreal Gen Hosp", "geoPoint"=>{"lat"=>45.50884, "lon"=>-73.58781}}, {"zip"=>"00908", "city"=>"Santurce", "country"=>"Puerto Rico", "facility"=>"Advance Community Health Services Inc", "geoPoint"=>{"lat"=>18.19523, "lon"=>-67.14018}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Glaxo Wellcome", "class"=>"INDUSTRY"}}}}
