Nctid:
NCT00002155
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-11-01"}, "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"=>"M16355", "name"=>"Syndrome", "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"=>"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"=>"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"=>"M21243", "name"=>"Lamivudine", "asFound"=>"Central", "relevance"=>"HIGH"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M19609", "name"=>"HIV Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M14343", "name"=>"Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M17920", "name"=>"Zidovudine", "asFound"=>"Discretion", "relevance"=>"HIGH"}, {"id"=>"M21424", "name"=>"Indinavir", "asFound"=>"Myofascial Release", "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"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>600}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1996-06", "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"=>["Drug Therapy, Combination", "Acquired Immunodeficiency Syndrome", "Antiviral Agents", "Zidovudine", "HIV Protease Inhibitors", "Lamivudine", "Indinavir"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"9287228", "type"=>"BACKGROUND", "citation"=>"Gulick RM, Mellors JW, Havlir D, Eron JJ, Gonzalez C, McMahon D, Richman DD, Valentine FT, Jonas L, Meibohm A, Emini EA, Chodakewitz JA. Treatment with indinavir, zidovudine, and lamivudine in adults with human immunodeficiency virus infection and prior antiretroviral therapy. N Engl J Med. 1997 Sep 11;337(11):734-9. doi: 10.1056/NEJM199709113371102."}, {"pmid"=>"10438352", "type"=>"BACKGROUND", "citation"=>"Hirsch M, Steigbigel R, Staszewski S, Mellors J, Scerpella E, Hirschel B, Lange J, Squires K, Rawlins S, Meibohm A, Leavitt R. A randomized, controlled trial of indinavir, zidovudine, and lamivudine in adults with advanced human immunodeficiency virus type 1 infection and prior antiretroviral therapy. J Infect Dis. 1999 Sep;180(3):659-65. doi: 10.1086/314948."}]}, "descriptionModule"=>{"briefSummary"=>"To compare effects on CD4 counts and serum viral RNA among HIV-seropositive, zidovudine (AZT)-experienced patients in three treatment arms: indinavir sulfate ( MK-639; Crixivan ) plus AZT plus lamivudine ( 3TC ) versus MK-639 alone versus AZT/3TC.", "detailedDescription"=>"AZT-experienced patients are randomized to receive MK-639/AZT/3TC or MK-639 alone or AZT/3TC. Additionally, patients who have received \\< 6 months of AZT or who are intolerant but received prior 3TC or who require concomitant rifampin therapy may receive open-label MK-639."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed for all patients:\n\n* Standard prophylaxis for opportunistic infections.\n* Continuation of treatment for opportunistic infection.\n\nAllowed for open-label study patients:\n\n* Rifampin.\n\nPatients must have:\n\n* HIV positivity.\n* CD4 count \\<= 50 cells/mm3.\n* More than 6 months of prior AZT (blinded study only).\n\nNOTE:\n\n* Patients on the open-label study must have AZT intolerance or have \\< 6 months of prior AZT.\n\nPrior Medication:\n\nRequired for blinded study patients:\n\n* \\> 6 months of prior AZT.\n\nRequired for open-label study patients:\n\n* \\< 6 months of prior AZT.\n\nAllowed for open-label study patients:\n\n* Prior 3TC.\n\nExclusion Criteria\n\nConcurrent Medication:\n\nExcluded in all patients:\n\n* Immunosuppressants.\n\nExcluded in blinded study patients:\n\n* AZT, ddI, ddC, or d4T.\n* Rifampin.\n\nExcluded in open-label study patients:\n\n* 3TC.\n\nPrior Medication:\n\nExcluded in all patients:\n\n* Prior protease inhibitors.\n* Investigational agents and immunomodulators within 30 days prior to study entry.\n* Immunosuppressants within 2 weeks prior to study entry.\n\nExcluded in blinded study patients:\n\n* Any prior 3TC.\n* AZT, ddI, ddC, or d4T within 2 weeks prior to study entry.\n\nExcluded in open-label study patients:\n\n3TC within 30 days prior to study entry."}, "identificationModule"=>{"nctId"=>"NCT00002155", "briefTitle"=>"A Six-Month Safety and Antiviral Study in HIV-1 Seropositive, AZT-Experienced Patients With CD4 Counts Less Than or Equal to 50 Cells/mm3 to Evaluate MK-639 Alone Versus Zidovudine (AZT) and 3TC Versus the Combination of MK-639 With AZT/3TC", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Six-Month Safety and Antiviral Study in HIV-1 Seropositive, AZT-Experienced Patients With CD4 Counts Less Than or Equal to 50 Cells/mm3 to Evaluate MK-639 Alone Versus Zidovudine (AZT) and 3TC Versus the Combination of MK-639 With AZT/3TC", "orgStudyIdInfo"=>{"id"=>"246E"}, "secondaryIdInfos"=>[{"id"=>"039"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Indinavir sulfate", "type"=>"DRUG"}, {"name"=>"Lamivudine", "type"=>"DRUG"}, {"name"=>"Zidovudine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"088890100", "city"=>"Whitehouse Station", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Merck & Co Inc", "geoPoint"=>{"lat"=>40.61538, "lon"=>-74.77044}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Merck Sharp & Dohme LLC", "class"=>"INDUSTRY"}}}}