Nctid:
NCT00002333
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "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"=>"M6368", "name"=>"Communicable Diseases", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"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"=>"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"=>"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"=>"D019258", "term"=>"Saquinavir"}, {"id"=>"D016047", "term"=>"Zalcitabine"}], "ancestors"=>[{"id"=>"D017320", "term"=>"HIV Protease Inhibitors"}, {"id"=>"D000084762", "term"=>"Viral Protease Inhibitors"}, {"id"=>"D011480", "term"=>"Protease Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D019380", "term"=>"Anti-HIV Agents"}, {"id"=>"D044966", "term"=>"Anti-Retroviral Agents"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D065692", "term"=>"Cytochrome P-450 CYP3A Inhibitors"}, {"id"=>"D065607", "term"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"id"=>"D000963", "term"=>"Antimetabolites"}, {"id"=>"D018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}], "browseLeaves"=>[{"id"=>"M19609", "name"=>"HIV Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M14343", "name"=>"Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M17920", "name"=>"Zidovudine", "relevance"=>"LOW"}, {"id"=>"M21242", "name"=>"Saquinavir", "asFound"=>"SRS", "relevance"=>"HIGH"}, {"id"=>"M18546", "name"=>"Zalcitabine", "asFound"=>"Anorectal", "relevance"=>"HIGH"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}, {"id"=>"M25428", "name"=>"Anti-Retroviral Agents", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M30564", "name"=>"Cytochrome P-450 CYP3A Inhibitors", "relevance"=>"LOW"}, {"id"=>"M30537", "name"=>"Cytochrome P-450 Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "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"=>900}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1995-02", "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"=>["Zalcitabine", "Drug Therapy, Combination", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex", "Saquinavir", "HIV Protease Inhibitors"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Revicki D, Swartz C. Quality of life outcomes of saquinavir, zalcitabine and combination saquinavir-zalcitabine therapy for advanced HIV-infection. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:113 (abstract no 266)"}]}, "descriptionModule"=>{"briefSummary"=>"To compare the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone, zalcitabine (dideoxycytidine; ddC) alone, and both in combination, in patients discontinuing or unable to take zidovudine (AZT).", "detailedDescription"=>"Patients are randomized to one of three treatment regimens: ddC alone, Ro 31-8959 alone, and ddC plus Ro 31-8959. Treatment continues for at least 48 weeks. Patients are stratified by baseline CD4 count. (Per 09/26/94 amendment, a fourth arm, lower dose Ro 31-8959 plus ddC, was discontinued.)"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* G-CSF and erythropoietin.\n* Prophylaxis or chronic suppression/maintenance therapy with dapsone, aerosolized pentamidine, isoniazid, rifampin, fluoroquinolones, pyrazinamide, ethambutol, fluconazole, itraconazole, acyclovir, clotrimazole, nystatin, trimethoprim/sulfamethoxazole, pyrimethamine, folic acid, sulfadiazine, clindamycin, and fansidar.\n\nConcurrent Treatment:\n\nAllowed:\n\n* Limited localized radiation therapy to the skin.\n\nPatients must have:\n\n* Documented HIV infection.\n* CD4 count 50 - 300 cells/mm3.\n* Received prior AZT that has been discontinued at least 28 days prior to study entry.\n* No active opportunistic infection requiring immediate treatment.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Signs or symptoms of peripheral neuropathy.\n* Malabsorption or inadequate oral intake (defined as unable to eat one or more meals daily because of chronic nausea, emesis, or abdominal/oral-esophageal discomfort.\n* Malignancy, visceral Kaposi's sarcoma, or lymphoma requiring systemic chemotherapy and/or radiotherapy within the next 48 weeks.\n* Any grade 3 or worse laboratory or clinical abnormality.\n* Inability to comply with protocol requirements.\n\nConcurrent Medication:\n\nExcluded:\n\n* Other antiretroviral drugs.\n* Experimental drugs.\n* Nephrotoxic or hepatotoxic drugs.\n* Drugs likely to cause peripheral neuropathy.\n* Antineoplastic agents.\n* Biologic response modifiers.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Radiation therapy other than limited localized therapy to skin.\n\nPatients with the following prior conditions are excluded:\n\n* History of non-Hodgkin's lymphoma.\n* Unexplained fever \\>= 38.5 C (101.5 F) persisting for 14 days or longer within the 28 days prior to study entry.\n* Unexplained, chronic diarrhea (defined as 3 or more loose stools daily) persisting for 14 days or longer within the 28 days prior to study entry.\n* History of grade 2 or worse peripheral neuropathy.\n\nPrior Medication:\n\nExcluded:\n\n* Prior HIV proteinase inhibitor.\n* Prior antiretroviral therapy other than AZT.\n* Acute therapy for opportunistic infection within 14 days prior to study entry.\n\nPrior Treatment:\n\nExcluded:\n\n* More than 3 units of blood in any 21-day period within 3 months prior to study entry.\n\nRequired:\n\n* Prior AZT."}, "identificationModule"=>{"nctId"=>"NCT00002333", "briefTitle"=>"A Study of Saquinavir and Zalcitabine, Used Alone and Together, in the Treatment of Advanced HIV Infection in Patients Who Stopped Taking or Who Cannot Take Zidovudine", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Randomized, Double-Blind, Multicenter, Parallel Study of Ro 31-8959 (Saquinavir; HIV Proteinase Inhibitor) Alone, HIVID (Dideoxycytidine; Zalcitabine, ddC) Alone, and Both in Combination, as Treatment for Advanced HIV Infection (CD4 50-300 Cells/mm3) in Patients Discontinuing or Unable to Take Retrovir (Zidovudine; AZT) Therapy", "orgStudyIdInfo"=>{"id"=>"229A"}, "secondaryIdInfos"=>[{"id"=>"NV 14256B"}, {"id"=>"NV 14256A"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Saquinavir", "type"=>"DRUG"}, {"name"=>"Zalcitabine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90710", "city"=>"Harbor City", "state"=>"California", "country"=>"United States", "facility"=>"Kaiser Foundation Hosp", "geoPoint"=>{"lat"=>33.79002, "lon"=>-118.29785}}, {"zip"=>"920930679", "city"=>"La Jolla", "state"=>"California", "country"=>"United States", "facility"=>"UCSD", "geoPoint"=>{"lat"=>32.84727, "lon"=>-117.2742}}, {"zip"=>"900121973", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"UCLA School of Medicine", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"90095", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"CARE Ctr / UCLA Med Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"95817", "city"=>"Sacramento", "state"=>"California", "country"=>"United States", "facility"=>"UCD", "geoPoint"=>{"lat"=>38.58157, "lon"=>-121.4944}}, {"zip"=>"94110", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"UCSF - San Francisco Gen Hosp", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"94114", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Davies Med Ctr / c/o HIV Institute", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"94115", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Mount Zion Med Ctr / UCSF", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"94121", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"San Francisco Veterans Administration Med Ctr", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"91403", "city"=>"Sherman Oaks", "state"=>"California", "country"=>"United States", "facility"=>"Pacific Oaks Med Group / Rsch & Scientific Investigation", "geoPoint"=>{"lat"=>34.15112, "lon"=>-118.44925}}, {"zip"=>"94086", "city"=>"Sunnyvale", "state"=>"California", "country"=>"United States", "facility"=>"Sunnyvale Med Clinic", "geoPoint"=>{"lat"=>37.36883, "lon"=>-122.03635}}, {"zip"=>"90505", "city"=>"Torrance", "state"=>"California", "country"=>"United States", "facility"=>"Harbor - UCLA Med Ctr", "geoPoint"=>{"lat"=>33.83585, "lon"=>-118.34063}}, {"zip"=>"20422", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Veterans Administration Med Ctr", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"33140", "city"=>"Miami Beach", "state"=>"Florida", "country"=>"United States", "facility"=>"Stratogen of South Florida", "geoPoint"=>{"lat"=>25.79065, "lon"=>-80.13005}}, {"zip"=>"33125", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Miami Veterans Administration Med Ctr", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"33136", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ of Miami Dept of Medicine", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"30308", "city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"AIDS Research Consortium of Atlanta", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"30327", "city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"West Paces Clinical Research Incoporated", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Rush Presbyterian - 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New Jersey Med School / Cooper Hosp", "geoPoint"=>{"lat"=>39.92595, "lon"=>-75.11962}}, {"zip"=>"08103", "city"=>"Newark", "state"=>"New Jersey", "country"=>"United States", "facility"=>"UMDNJ - New Jersy Med School", "geoPoint"=>{"lat"=>40.73566, "lon"=>-74.17237}}, {"zip"=>"12208", "city"=>"Albany", "state"=>"New York", "country"=>"United States", "facility"=>"Albany Med College", "geoPoint"=>{"lat"=>42.65258, "lon"=>-73.75623}}, {"zip"=>"10003", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Beth Israel Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10011", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Saint Vincent's Hosp and Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10032", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Harkness Pavilion", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"43210", "city"=>"Columbus", "state"=>"Ohio", "country"=>"United States", "facility"=>"Ohio State Univ Hosp", "geoPoint"=>{"lat"=>39.96118, "lon"=>-82.99879}}, {"zip"=>"97201", "city"=>"Portland", "state"=>"Oregon", "country"=>"United States", "facility"=>"Oregon Health Sciences Univ", "geoPoint"=>{"lat"=>45.52345, "lon"=>-122.67621}}, {"zip"=>"19107", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Thomas Jefferson Med College", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"19146", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Graduate Hosp / Tuttleman Cancer Ctr", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"38163", "city"=>"Memphis", "state"=>"Tennessee", "country"=>"United States", "facility"=>"Univ of Tennessee", "geoPoint"=>{"lat"=>35.14953, "lon"=>-90.04898}}, {"zip"=>"75219", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"Oaklawn Physicians Group", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"775550882", "city"=>"Galveston", "state"=>"Texas", "country"=>"United States", "facility"=>"Univ TX Galveston Med Branch", "geoPoint"=>{"lat"=>29.30135, "lon"=>-94.7977}}, {"zip"=>"77005", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Baylor College of Medicine", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"98104", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"Univ of Washington / Harborview Med Ctr", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}, {"city"=>"Calgary", "state"=>"Alberta", "country"=>"Canada", "facility"=>"Southern Alberta HIV Clinic", "geoPoint"=>{"lat"=>51.05011, "lon"=>-114.08529}}, {"city"=>"Hamilton", "state"=>"Ontario", "country"=>"Canada", "facility"=>"McMaster Univ Med Ctr", "geoPoint"=>{"lat"=>43.25011, "lon"=>-79.84963}}, {"city"=>"Toronto", "state"=>"Ontario", "country"=>"Canada", "facility"=>"Sunnybrook Health Science Ctr", "geoPoint"=>{"lat"=>43.70011, "lon"=>-79.4163}}, {"city"=>"Montreal", "state"=>"Quebec", "country"=>"Canada", "facility"=>"Clinique Medicale L'Actuele", "geoPoint"=>{"lat"=>45.50884, "lon"=>-73.58781}}, {"city"=>"Montreal", "state"=>"Quebec", "country"=>"Canada", "facility"=>"Montreal Gen Hosp", "geoPoint"=>{"lat"=>45.50884, "lon"=>-73.58781}}, {"zip"=>"009275800", "city"=>"San Juan", "country"=>"Puerto Rico", "facility"=>"San Juan Veterans Administration Med Ctr", "geoPoint"=>{"lat"=>18.46633, "lon"=>-66.10572}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Hoffmann-La Roche", "class"=>"INDUSTRY"}}}}
