Nctid:
NCT00000679
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-21"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000015658", "term"=>"HIV Infections"}], "ancestors"=>[{"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D000003141", "term"=>"Communicable Diseases"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000015229", "term"=>"Sexually Transmitted Diseases, Viral"}, {"id"=>"D000012749", "term"=>"Sexually Transmitted Diseases"}, {"id"=>"D000016180", "term"=>"Lentivirus Infections"}, {"id"=>"D000012192", "term"=>"Retroviridae Infections"}, {"id"=>"D000012327", "term"=>"RNA Virus Infections"}, {"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000007153", "term"=>"Immunologic Deficiency Syndromes"}, {"id"=>"D000007154", "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"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "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"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000015215", "term"=>"Zidovudine"}, {"id"=>"D000016047", "term"=>"Zalcitabine"}], "ancestors"=>[{"id"=>"D000000963", "term"=>"Antimetabolites"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D000019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000000998", "term"=>"Antiviral Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000019380", "term"=>"Anti-HIV Agents"}, {"id"=>"D000044966", "term"=>"Anti-Retroviral Agents"}], "browseLeaves"=>[{"id"=>"M17920", "name"=>"Zidovudine", "asFound"=>"HPV", "relevance"=>"HIGH"}, {"id"=>"M18546", "name"=>"Zalcitabine", "asFound"=>"Initial assessment", "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"=>"M21350", "name"=>"Anti-HIV 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"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>600}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1994-12", "lastUpdateSubmitDate"=>"2011-03-11", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2011-03-14", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"1994-02", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["Zalcitabine", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex", "Zidovudine"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"8028406", "type"=>"BACKGROUND", "citation"=>"Bozzette SA, Hays RD, Berry SH, Kanouse DE. A Perceived Health Index for use in persons with advanced HIV disease: derivation, reliability, and validity. Med Care. 1994 Jul;32(7):716-31. doi: 10.1097/00005650-199407000-00005."}, {"pmid"=>"7859137", "type"=>"BACKGROUND", "citation"=>"Bozzette SA, Hays RD, Berry SH, Kanouse DE, Wu AW. Derivation and properties of a brief health status assessment instrument for use in HIV disease. J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Mar 1;8(3):253-65. doi: 10.1097/00042560-199503010-00006."}, {"pmid"=>"7815656", "type"=>"BACKGROUND", "citation"=>"Bozzette SA, Kanouse DE, Berry S, Duan N. Health status and function with zidovudine or zalcitabine as initial therapy for AIDS. A randomized controlled trial. Roche 3300/ACTG 114 Study Group. JAMA. 1995 Jan 25;273(4):295-301."}, {"type"=>"BACKGROUND", "citation"=>"Bozzette SA, Kanouse D, Berry S, Duan N, Downes-LeGuin T, Hays R, Petinnelli C, Richman DD, Gocke D, Kahn J. Relative effects of ddC or ddI versus ZDV on health status, function and disability in N3300 (ACTG 114) and ACTG 116b/117. Int Conf AIDS. 1992 Jul 19-24;8(1):Mo21 (abstract no MoB 0077)"}, {"type"=>"BACKGROUND", "citation"=>"Remick S, Follansbee S, Olson R, Pollard R, Reiter W, Salgo M. Safety and tolerance of zalcitabine (ddC, HIVID) in a double-blind, comparative trial (ACTG 114; N3300). Int Conf AIDS. 1993 Jun 6-11;9(1):488 (abstract no PO-B26-2115)"}, {"type"=>"BACKGROUND", "citation"=>"Follansbee S, Drew L, Olson R, Pollard R, Relter W, Salgo M. The efficacy of zalcitabine (ddC, HIVID) versus zidovudine (ZDV) as monotherapy in ZDV naive patients with advanced HIV disease: a randomized, double-blind, comparative trial (ACTG 114; N3300). Int Conf AIDS. 1993 Jun 6-11;9(1):487 (abstract no PO-B26-2113)"}, {"pmid"=>"9024175", "type"=>"BACKGROUND", "citation"=>"Gries JM, Troconiz IF, Verotta D, Jacobson M, Sheiner LB. A pooled analysis of CD4 response to zidovudine and zalcitabine treatment in patients with AIDS and AIDS-related complex. Clin Pharmacol Ther. 1997 Jan;61(1):70-82. doi: 10.1016/S0009-9236(97)90183-1."}]}, "descriptionModule"=>{"briefSummary"=>"To show that zalcitabine (dideoxycytidine; ddC) is at least as effective as zidovudine (AZT) in the treatment of AIDS or advanced AIDS related complex (ARC), and also that ddC shows a different safety profile than AZT.\n\nIn clinical studies, ddC shows antiviral activity. Because of the antiviral activity, and because of the low incidence of mild, reversible neurotoxicity and absence of blood-related toxicity with low dose ddC therapy, a long-term Phase II/III study comparing ddC to AZT in patients with AIDS or advanced ARC is now warranted.", "detailedDescription"=>"In clinical studies, ddC shows antiviral activity. Because of the antiviral activity, and because of the low incidence of mild, reversible neurotoxicity and absence of blood-related toxicity with low dose ddC therapy, a long-term Phase II/III study comparing ddC to AZT in patients with AIDS or advanced ARC is now warranted.\n\nAfter screening, physical examination and laboratory tests (within 14 days of entry) patients are randomized to one of two treatment groups. They receive either ddC plus an AZT placebo or AZT plus a ddC placebo. Because it is a blinded study, patients do not know which group they are in. Patients are evaluated weekly for the first 10 weeks and then biweekly thereafter."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Aerosolized pentamidine (300 mg once every 4 weeks) for Pneumocystis carinii pneumonia (PCP) prophylaxis.\n* Neuroleptics, benzodiazepines, or antidepressants if patient has been stable with chronic treatment \\> 1 month.\n* Low dose benzodiazepines or low dose antidepressants.\n* Drugs that are unlikely to cause increased toxicity with either study drug and are unlikely to cause peripheral neuropathy.\n* Drugs with little nephrotoxicity, hepatotoxicity, or cytotoxicity that the patient has been taking and tolerating well.\n* Acyclovir (up to 600 mg/kg/day) for up to 21 days.\n* Ketoconazole (up to 400 mg/day) Nystatin.\n* Low-dose acetaminophen or nonsteroidal anti-inflammatory agents.\n* Isoniazid if patient has no evidence of peripheral neuropathy at entry and if patient takes 50 mg/day pyridoxine concomitantly with isoniazid.\n* Allowed with interruption of study medication for up to 21 days per episode and for a total of 42 days for the study:\n* Drugs that could cause serious additive toxicity when coadministered with either study medication for treatment of an acute intercurrent illness or opportunistic infection, including:\n* Acyclovir (\\< 600 mg/day), fluconazole, systemic pentamidine, foscarnet, pyrimethamine, triple sulfa, ansamycin, ganciclovir, trimethoprim / sulfamethoxazole.\n\nPatients must have a diagnosis of AIDS or advanced AIDS related complex (ARC). At least 20 percent of the patients must have a consistently positive serum HIV p24 antigen (= or \\> 70 pg/ml) as defined by the Abbott HIV antigen test, on two separate occasions at least 72 hours apart.\n\n* Patients found at screening to have a temperature \\> 38.5 degrees C should be evaluated for the possibility of an occult opportunistic or bacterial infection or neoplasm. If this complete evaluation reveals an infection, they can be entered. If this evaluation is unrevealing, they may be entered after evaluation is completed but while mycobacterial cultures are still pending. Patients with a history of unexplained temperatures \\> 38.5 degrees C should be evaluated as above and/or be afebrile (temperature \\< 38.0 degrees C) for 2 weeks prior to study entry.\n* Allowed: Kaposi's sarcoma not specifically excluded, basal cell carcinoma of the skin or in situ carcinoma of the cervix.\n* Current positive venereal disease research label (VDRL) and fluorescent treponemal antibody (FTA) if treated as for asymptomatic neurosyphilis.\n\nPrior Medication:\n\nAllowed:\n\n* Drugs that cause peripheral neuropathy and drugs that could cause significant increased toxicity with zidovudine (AZT) or dideoxycytidine (ddC) including experimental drugs if therapy with these drugs is completed and patient is stable for 14 days.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Active AIDS defining opportunistic infection or other active intercurrent illness is excluded if ongoing treatment requires the use of excluded concomitant medication.\n* Patients with symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to entry into the study, or with current neoplasms not specifically allowed.\n* Severe AIDS dementia complex defined by a score of \\< 23 on the Mini-Mental State Exam.\n* Signs, symptoms, or history of peripheral neuropathy.\n* Significant cardiac disease, defined as history of ventricular arrhythmias requiring medication, prior myocardial infarct, or history of angina or ischemia changes on ECG (electrocardiography).\n* Requiring \\> 2 weeks of acyclovir therapy at \\> 600 mg/day.\n* Current positive venereal disease research label (VDRL) and fluorescent treponemal antibody (FTA) not specifically allowed.\n* Significant liver disease.\n\nConcurrent Medication:\n\nExcluded:\n\n* Drugs that cause peripheral neuropathy:\n* chloramphenicol, cisplatinum, iodoquinol, dapsone, phenytoin, disulfiram, ethionamide, glutethimide, gold, hydralazine, ribavirin, metronidazole, vincristine, nitrofurantoin.\n* Drugs that could cause significant increased toxicity with zidovudine (AZT) or dideoxycytidine (ddC), including experimental drugs not specifically allowed.\n* Drugs that could cause seizures or changes in mental status or neurological examination.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Transfusion dependency.\n\nPatients with the following are excluded:\n\n* Active AIDS defining opportunistic infection or other active intercurrent illness if ongoing treatment requires use of excluded concomitant medication.\n* Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to study entry, or current neoplasms not specifically allowed.\n* Severe AIDS dementia complex defined by a score of \\< 23 on the Mini-Mental State Exam.\n* Signs, symptoms, or history of peripheral neuropathy.\n* Unwilling or unable to sign informed consent.\n\nPrior Medication:\n\nExcluded:\n\n* Zidovudine (AZT), dideoxycytidine (ddC), or any other antiretroviral nucleoside analog.\n* Excluded within 90 days of study entry:\n* Any experimental drug including fluconazole, ganciclovir, foscarnet, erythropoietin, or ribavirin.\n\nExcluded within 90 days of study entry:\n\n* Drugs that have caused significant nephrotoxicity or significant hepatotoxicity.\n* Drugs that could cause peripheral neuropathy including phenytoin, hydralazine, metronidazole, and nitrofurantoin.\n* Systemic corticosteroids or immunomodulators including interferon and interleukin.\n\nPrior Treatment:\n\nExcluded within 30 days of study entry:\n\n* Radiation therapy.\n\nActive substance or alcohol abuse."}, "identificationModule"=>{"nctId"=>"NCT00000679", "briefTitle"=>"(Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) Versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"(Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) Versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC", "orgStudyIdInfo"=>{"id"=>"ACTG 114"}, "secondaryIdInfos"=>[{"id"=>"Protocol Number: N3300A"}, {"id"=>"FDA 31A"}, {"id"=>"Study Number: 3-27"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Zidovudine", "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"=>"90027", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Kaiser Permanente Med Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"95817", "city"=>"Sacramento", "state"=>"California", "country"=>"United States", "facility"=>"UCD Med Ctr", "geoPoint"=>{"lat"=>38.58157, "lon"=>-121.4944}}, {"zip"=>"94114", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Davies Med Ctr", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"94115", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Mount Zion Med Ctr", "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"=>"95128", "city"=>"San Jose", "state"=>"California", "country"=>"United States", "facility"=>"Santa Clara Valley Med Ctr", "geoPoint"=>{"lat"=>37.33939, "lon"=>-121.89496}}, {"zip"=>"20007", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Georgetown Univ Med Ctr", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"33308", "city"=>"Fort Lauderdale", "state"=>"Florida", "country"=>"United States", "facility"=>"Ctr for Special Immunology", "geoPoint"=>{"lat"=>26.12231, "lon"=>-80.14338}}, {"zip"=>"33901", "city"=>"Fort Myers", "state"=>"Florida", "country"=>"United States", "facility"=>"Comprehensive Clinic / Dr Robert Schwartz", "geoPoint"=>{"lat"=>26.62168, "lon"=>-81.84059}}, {"zip"=>"33125", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Med Service", "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"=>"60611", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Northwestern Univ Med School", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Rush Presbyterian - Saint Luke's Med Ctr", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"02111", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"New England Med Ctr", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"48202", "city"=>"Detroit", "state"=>"Michigan", "country"=>"United States", "facility"=>"Henry Ford Hosp", "geoPoint"=>{"lat"=>42.33143, "lon"=>-83.04575}}, {"zip"=>"07102", "city"=>"Newark", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Saint Michael's Med Ctr", "geoPoint"=>{"lat"=>40.73566, "lon"=>-74.17237}}, {"zip"=>"12203", "city"=>"Albany", "state"=>"New York", "country"=>"United States", "facility"=>"Albany Med College / AIDS Treatment Ctr", "geoPoint"=>{"lat"=>42.65258, "lon"=>-73.75623}}, {"zip"=>"11220", "city"=>"Brooklyn", "state"=>"New York", "country"=>"United States", "facility"=>"Sunset Park Health Ctr - Lutheran Med Ctr", "geoPoint"=>{"lat"=>40.6501, "lon"=>-73.94958}}, {"zip"=>"27103", "city"=>"Winston-Salem", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Bowman Gray School of Medicine / North Carolina Baptist Hosp", "geoPoint"=>{"lat"=>36.09986, "lon"=>-80.24422}}, {"zip"=>"44106", "city"=>"Cleveland", "state"=>"Ohio", "country"=>"United States", "facility"=>"Univ Hosp of Cleveland / Case Western Reserve Univ", "geoPoint"=>{"lat"=>41.4995, "lon"=>-81.69541}}, {"zip"=>"19146", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Graduate Hosp", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"75219", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"N Texas Ctr for AIDS & Clin Rsch", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"77550", "city"=>"Galveston", "state"=>"Texas", "country"=>"United States", "facility"=>"Univ TX Galveston Med Branch", "geoPoint"=>{"lat"=>29.30135, "lon"=>-94.7977}}, {"zip"=>"77030", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Baylor College of Medicine", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Hoffmann-La Roche", "class"=>"INDUSTRY"}]}}}
