Nctid:
NCT00002410
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"=>"D019259", "term"=>"Lamivudine"}, {"id"=>"D015215", "term"=>"Zidovudine"}, {"id"=>"D019469", "term"=>"Indinavir"}], "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"}, {"id"=>"D017320", "term"=>"HIV Protease Inhibitors"}, {"id"=>"D000084762", "term"=>"Viral Protease Inhibitors"}, {"id"=>"D011480", "term"=>"Protease Inhibitors"}], "browseLeaves"=>[{"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M340137", "name"=>"Efavirenz", "relevance"=>"LOW"}, {"id"=>"M25428", "name"=>"Anti-Retroviral Agents", "relevance"=>"LOW"}, {"id"=>"M21243", "name"=>"Lamivudine", "asFound"=>"Next", "relevance"=>"HIGH"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}, {"id"=>"M19609", "name"=>"HIV Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M14343", "name"=>"Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M17920", "name"=>"Zidovudine", "asFound"=>"Corticosteroid", "relevance"=>"HIGH"}, {"id"=>"M21424", "name"=>"Indinavir", "asFound"=>"Discontinue", "relevance"=>"HIGH"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective 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"=>{"primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1998-11", "lastUpdateSubmitDate"=>"2005-06-23", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2005-06-24", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["HIV-1", "Drug Therapy, Combination", "Zidovudine", "Drug Resistance, Microbial", "HIV Protease Inhibitors", "Lamivudine", "Indinavir", "Genotype", "Reverse Transcriptase Inhibitors", "efavirenz"], "conditions"=>["HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to compare the safety and effectiveness of three anti-HIV drug combinations. The three combinations are: (1) efavirenz (DMP 266) plus indinavir; (2) DMP 266 plus zidovudine (ZDV) plus lamivudine (3TC); and (3) indinavir plus ZDV plus 3TC. This study also examines the resistance HIV may have to these drugs and if these drugs are effective over a long period of time."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"13 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Exclusion Criteria\n\nConcurrent Medication:\n\nExcluded:\n\n* Terfenadine, astemizole, cisapride, triazolam, or midazolam (competition for the enzyme cytochrome P-450 3A4 \\[CYP3A4\\] by indinavir could result in inhibition of metabolic breakdown of these drugs and create the potential for serious and/or life threatening events \\[i.e., cardiac arrhythmia, prolonged sedation\\]).\n* Rifampin or rifabutin (prohibited because of potential drug interaction with indinavir).\n* Ketoconazole, itraconazole, and clarithromycin.\n* Concomitant systemic therapy for acute opportunistic infection or malignancy.\n\nExcluded:\n\nLife expectancy less than 12 months.\n\nPrior Medication:\n\nExcluded:\n\n* Prior treatment with efavirenz, 3TC, an NNRTI, or an HIV protease inhibitor.\n* Prior antiretroviral agent within 14 days of initiating study treatment.\n* Prior treatment (within 30 days of initiating study treatment) with any other experimental drug for any indication.\n\nPatients must:\n\n* Have a diagnosis of HIV infection.\n* Have CD4 counts greater than or equal to 50 cell/mm3.\n* Have a life expectancy greater than or equal to 12 months.\n* Be post-pubescent."}, "identificationModule"=>{"nctId"=>"NCT00002410", "briefTitle"=>"A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Phase III, Multicenter, Randomized, Open-Label Study to Compare Antiretroviral Activity and Tolerability of Three Different Combination Regimens (DMP 266 + Indinavir, DMP 266 + Zidovudine + Lamivudine, Indinavir + Zidovudine + Lamivudine) in HIV-Infected Patients", "orgStudyIdInfo"=>{"id"=>"281B"}, "secondaryIdInfos"=>[{"id"=>"DMP 266-006"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Indinavir sulfate", "type"=>"DRUG"}, {"name"=>"Lamivudine", "type"=>"DRUG"}, {"name"=>"Zidovudine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"85016", "city"=>"Phoenix", "state"=>"Arizona", "country"=>"United States", "facility"=>"Phoenix Body Positive", "geoPoint"=>{"lat"=>33.44838, "lon"=>-112.07404}}, {"zip"=>"85712", "city"=>"Tucson", "state"=>"Arizona", "country"=>"United States", "facility"=>"Arizona Clinical Research Ctr Inc", "geoPoint"=>{"lat"=>32.22174, "lon"=>-110.92648}}, {"zip"=>"90210", "city"=>"Beverly Hills", "state"=>"California", "country"=>"United States", "facility"=>"Richard Stryker", "geoPoint"=>{"lat"=>34.07362, "lon"=>-118.40036}}, {"zip"=>"92618", "city"=>"Irvine", "state"=>"California", "country"=>"United States", "facility"=>"Paul Cimoch", "geoPoint"=>{"lat"=>33.66946, "lon"=>-117.82311}}, {"zip"=>"90027", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"AIDS Healthcare Foundation", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"90036", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Kraus Med Group", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"90059", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Oasis Clinic / Martin Luther Jr Gen Hosp / King-Drew Med Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"06901", "city"=>"Stamford", "state"=>"Connecticut", "country"=>"United States", "facility"=>"Blick Med Associates", "geoPoint"=>{"lat"=>41.05343, "lon"=>-73.53873}}, {"zip"=>"20037", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Novum Inc", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"34205", "city"=>"Bradenton", "state"=>"Florida", "country"=>"United States", "facility"=>"Bach and Godofsky", "geoPoint"=>{"lat"=>27.49893, "lon"=>-82.57482}}, {"zip"=>"33146", "city"=>"Coral Gables", "state"=>"Florida", "country"=>"United States", "facility"=>"Community Research Initiative of South Florida", "geoPoint"=>{"lat"=>25.72149, "lon"=>-80.26838}}, {"zip"=>"32209", "city"=>"Jacksonville", "state"=>"Florida", "country"=>"United States", "facility"=>"Boulevard Comprehensive Care Ctr", "geoPoint"=>{"lat"=>30.33218, "lon"=>-81.65565}}, {"zip"=>"33463", "city"=>"Lake Worth", "state"=>"Florida", "country"=>"United States", "facility"=>"Larry Marc Bush / c/o Sally Yantis", "geoPoint"=>{"lat"=>26.61708, "lon"=>-80.07231}}, {"zip"=>"33136", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ of Miami School of Medicine", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"33609", "city"=>"Tampa", "state"=>"Florida", "country"=>"United States", "facility"=>"Ctr for Quality Care", "geoPoint"=>{"lat"=>27.94752, "lon"=>-82.45843}}, {"zip"=>"33614", "city"=>"Tampa", "state"=>"Florida", "country"=>"United States", "facility"=>"Daniel Seekins", "geoPoint"=>{"lat"=>27.94752, "lon"=>-82.45843}}, {"zip"=>"33614", "city"=>"Tampa", "state"=>"Florida", "country"=>"United States", "facility"=>"Infectious Disease Research Institute", "geoPoint"=>{"lat"=>27.94752, "lon"=>-82.45843}}, {"zip"=>"32960", "city"=>"Vero Beach", "state"=>"Florida", "country"=>"United States", "facility"=>"Treasure Coast Infectious Disease Consultants", "geoPoint"=>{"lat"=>27.63864, "lon"=>-80.39727}}, {"zip"=>"30342", "city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"Georgia Research Associates", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"30912", "city"=>"Augusta", "state"=>"Georgia", "country"=>"United States", "facility"=>"Med College of Georgia", "geoPoint"=>{"lat"=>33.47097, "lon"=>-81.97484}}, {"zip"=>"46202", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Infectious Diseases", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"zip"=>"40536", "city"=>"Lexington", "state"=>"Kentucky", "country"=>"United States", "facility"=>"Univ of Kentucky Med Ctr", "geoPoint"=>{"lat"=>37.98869, "lon"=>-84.47772}}, {"zip"=>"64111", "city"=>"Kansas City", "state"=>"Missouri", "country"=>"United States", "facility"=>"Kansas City AIDS Research Consortium", "geoPoint"=>{"lat"=>39.09973, "lon"=>-94.57857}}, {"zip"=>"681985400", "city"=>"Omaha", "state"=>"Nebraska", "country"=>"United States", "facility"=>"Univ of Nebraska Med Ctr / HIV Clinic", "geoPoint"=>{"lat"=>41.25626, "lon"=>-95.94043}}, {"zip"=>"89102", "city"=>"Las Vegas", "state"=>"Nevada", "country"=>"United States", "facility"=>"Univ Med Ctr / HIV Wellness Ctr", "geoPoint"=>{"lat"=>36.17497, "lon"=>-115.13722}}, {"zip"=>"10001", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Community Research Initiative on AIDS", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10011", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Clinical Directors Network / HIV/AIDS Program Manager", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"27157", "city"=>"Winston Salem", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Wake Forest Univ School of Medicine", "geoPoint"=>{"lat"=>36.09986, "lon"=>-80.24422}}, {"zip"=>"43215", "city"=>"Columbus", "state"=>"Ohio", "country"=>"United States", "facility"=>"Remington-Davis Inc", "geoPoint"=>{"lat"=>39.96118, "lon"=>-82.99879}}, {"zip"=>"19107", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Philadelphia FIGHT", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"02906", "city"=>"Providence", "state"=>"Rhode Island", "country"=>"United States", "facility"=>"The Miriam Hosp", "geoPoint"=>{"lat"=>41.82399, "lon"=>-71.41283}}, {"zip"=>"75208", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"Research Services 2000 Inc", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"752359113", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"Division of Infectious Disease / Dept of Internal Medicine", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"76103", "city"=>"Fort Worth", "state"=>"Texas", "country"=>"United States", "facility"=>"Research Services 2000 Inc", "geoPoint"=>{"lat"=>32.72541, "lon"=>-97.32085}}, {"zip"=>"77006", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Montrose Clinic", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"77030", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"UT-Health Science Ctr", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"78229", "city"=>"San Antonio", "state"=>"Texas", "country"=>"United States", "facility"=>"Diagnostic Clinic of San Antonio", "geoPoint"=>{"lat"=>29.42412, "lon"=>-98.49363}}, {"zip"=>"23606", "city"=>"Newport News", "state"=>"Virginia", "country"=>"United States", "facility"=>"Oyster Point Med Specialists", "geoPoint"=>{"lat"=>37.08339, "lon"=>-76.46965}}, {"zip"=>"98122", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"Novum Inc / Pharmaceutical Research Services", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}, {"zip"=>"53215", "city"=>"Milwaukee", "state"=>"Wisconsin", "country"=>"United States", "facility"=>"Infectious Diseases Associates", "geoPoint"=>{"lat"=>43.0389, "lon"=>-87.90647}}, {"zip"=>"00909", "city"=>"San Juan", "country"=>"Puerto Rico", "facility"=>"Javier O Morales Ramirez", "geoPoint"=>{"lat"=>18.46633, "lon"=>-66.10572}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Dupont Merck", "class"=>"INDUSTRY"}}}}
