Nctid:
NCT00000831
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"=>"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"=>"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"=>"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"=>"D016049", "term"=>"Didanosine"}, {"id"=>"D018119", "term"=>"Stavudine"}], "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"=>"M20272", "name"=>"Stavudine", "asFound"=>"Lithium", "relevance"=>"HIGH"}, {"id"=>"M18548", "name"=>"Didanosine", "asFound"=>"IV bolus", "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"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>280}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1998-05", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-27", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-11-04", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Didanosine", "Drug Therapy, Combination", "AIDS-Related Complex", "Antiviral Agents", "Zidovudine", "Stavudine", "Lamivudine", "Drug Combinations"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"11468426", "type"=>"BACKGROUND", "citation"=>"Shulman NS, Machekano RA, Shafer RW, Winters MA, Zolopa AR, Liou SH, Hughes M, Katzenstein DA; AIDS Clinical Trials Group 302 Study Team. Genotypic correlates of a virologic response to stavudine after zidovudine monotherapy. J Acquir Immune Defic Syndr. 2001 Aug 1;27(4):377-80. doi: 10.1097/00126334-200108010-00008."}, {"pmid"=>"10933617", "type"=>"BACKGROUND", "citation"=>"Katzenstein DA, Hughes M, Albrecht M, Hammer S, Para M, Murphy R, Valdez H, Haubrich R, Liou S. Virologic and CD4+ cell responses to new nucleoside regimens: switching to stavudine or adding lamivudine after prolonged zidovudine treatment of human immunodeficiency virus infection. ACTG 302 Study Team. AIDS Clinical Trials Group. AIDS Res Hum Retroviruses. 2000 Jul 20;16(11):1031-7. doi: 10.1089/08892220050075282."}, {"pmid"=>"12394789", "type"=>"BACKGROUND", "citation"=>"Shulman NS, Hughes MD, Winters MA, Shafer RW, Zolopa AR, Hellmann NS, Bates M, Whitcomb JM, Katzenstein DA. Subtle decreases in stavudine phenotypic susceptibility predict poor virologic response to stavudine monotherapy in zidovudine-experienced patients. J Acquir Immune Defic Syndr. 2002 Oct 1;31(2):121-7. doi: 10.1097/00126334-200210010-00001."}]}, "descriptionModule"=>{"briefSummary"=>"To elucidate the relationship between virologic risk factors and immunologic and clinical progression in patients receiving monotherapy in protocol ACTG 175, and to compare new treatment regimens with combinations of reverse transcriptase inhibitors in long-term recipients of monotherapy. Specifically, to determine, in patients who have been taking zidovudine (AZT) alone for a long time, whether it is beneficial to add lamivudine (3TC) to AZT or to switch to d4T alone, and also to determine, in patients who have been taking didanosine (ddI) alone for a long time, whether it is beneficial to add AZT or AZT/3TC to ddI.\n\nCharacteristics of virus replication, pathogenicity, and resistance are thought to determine the durability of virologic and clinical response to nucleoside reverse transcriptase inhibitors. Previous results of ACTG 175 suggest that either a switch to ddI or addition of ddI in patients receiving AZT results in better clinical, virologic, and CD4 cell response compared to continuation of AZT alone.", "detailedDescription"=>"Characteristics of virus replication, pathogenicity, and resistance are thought to determine the durability of virologic and clinical response to nucleoside reverse transcriptase inhibitors. Previous results of ACTG 175 suggest that either a switch to ddI or addition of ddI in patients receiving AZT results in better clinical, virologic, and CD4 cell response compared to continuation of AZT alone.\n\nPatients with prior AZT experience only are randomized to receive either d4T alone or AZT/3TC. Patients with prior ddI experience only are randomized to receive ddI/AZT or ddI/AZT/3TC. PER AMENDMENT 8/27/96: The study has been extended 6 months and treatment will be available until March 15, 1997 at the latest. Each patient will have regularly scheduled 12 week safety visits during the extension period.\n\nAS PER AMENDMENT 1/22/97: The study has been extended for approximately 16 additional weeks beyond the current 6-month extension. Subjects will be unblinded to their assigned regimen beginning 2/21/97 and will continue therapy for up to 16 weeks in open-label fashion. AS PER AMENDMENT 5/9/97: The study has been extended for an additional 8 weeks; study drug will not be provided after 9/15/97."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"12 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nRecommended:\n\n* PCP prophylaxis in patients with CD4 count \\<= 200 cells/mm3.\n\nAllowed:\n\n* Chemophylaxis against Mycobacterium tuberculosis.\n* Acyclovir.\n* Vaccination with pneumococcal vaccine polyvalent.\n* Haemophilus B Conjugate vaccine.\n* Chemoprophylaxis for MAC and Toxoplasma gondii.\n* Antibiotics.\n* Recombinant erythropoietin ( EPO ) and G-CSF.\n* Systemic corticosteroids for \\< 21 days.\n* Regularly prescribed medications such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, and oral contraceptives.\n* Vitamins and herbal therapies.\n\nConcurrent Treatment:\n\nAllowed:\n\n* Limited local radiation therapy to skin.\n* Blood transfusions if 3 units or less per 21-day period.\n* Acupuncture.\n* Visualization techniques.\n\nPatients must have:\n\n* Completed AZT or ddI monotherapy on ACTG 175 and remained on that regimen during any subsequent interval.\n* Not reached an ACTG 175 endpoint prior to May 1, 1995.\n* Consent of parent or guardian if less than 18 years old.\n\nPER AMENDMENT 8/27/96:\n\n* Patients must be on study/on treatment at the time the protocol study treatment is extended.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Grade 2 or worse peripheral neuropathy.\n* Malignancy requiring systemic therapy.\n\nConcurrent Medication:\n\nExcluded:\n\n* Anti-HIV drugs other than study drugs.\n* Biologic response modifiers.\n* Systemic cytotoxic chemotherapy.\n* Any drug known to affect glucuronidation and/or clearance of AZT.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Radiation therapy other than limited local therapy to skin.\n\nPatients with the following prior condition are excluded:\n\n* History of acute or chronic pancreatitis.\n\nPrior Medication:\n\nExcluded:\n\n* Prior 3TC.\n* Acute therapy for an infection (other than HIV) or other medical illness within 14 days prior to study entry.\n\nCurrent ethanol abuse."}, "identificationModule"=>{"nctId"=>"NCT00000831", "briefTitle"=>"Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy", "orgStudyIdInfo"=>{"id"=>"ACTG 302"}, "secondaryIdInfos"=>[{"id"=>"11277", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Lamivudine", "type"=>"DRUG"}, {"name"=>"Stavudine", "type"=>"DRUG"}, {"name"=>"Zidovudine", "type"=>"DRUG"}, {"name"=>"Didanosine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"Alabama Therapeutics CRS", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"90033", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"USC CRS", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"90095", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"UCLA CARE Center CRS", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"94305", "city"=>"Palo Alto", "state"=>"California", "country"=>"United States", "facility"=>"Stanford CRS", "geoPoint"=>{"lat"=>37.44188, "lon"=>-122.14302}}, {"zip"=>"92103", "city"=>"San Diego", "state"=>"California", "country"=>"United States", "facility"=>"Ucsd, Avrc Crs", "geoPoint"=>{"lat"=>32.71533, "lon"=>-117.15726}}, {"city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Ucsf Aids Crs", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"city"=>"San Jose", "state"=>"California", "country"=>"United States", "facility"=>"Santa Clara Valley Med. Ctr.", "geoPoint"=>{"lat"=>37.33939, "lon"=>-121.89496}}, {"city"=>"San Mateo", "state"=>"California", "country"=>"United States", "facility"=>"San Mateo County AIDS Program", "geoPoint"=>{"lat"=>37.56299, "lon"=>-122.32553}}, {"zip"=>"90502", "city"=>"Torrance", "state"=>"California", "country"=>"United States", "facility"=>"Harbor-UCLA Med. Ctr. CRS", "geoPoint"=>{"lat"=>33.83585, "lon"=>-118.34063}}, {"city"=>"Aurora", "state"=>"Colorado", "country"=>"United States", "facility"=>"University of Colorado Hospital CRS", "geoPoint"=>{"lat"=>39.72943, "lon"=>-104.83192}}, {"city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ. of Miami AIDS CRS", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"30365", "city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"Emory Univ. Hemophilia Program Office", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"60611", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Northwestern University CRS", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Cook County Hosp. CORE Ctr.", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Rush Univ. Med. Ctr. ACTG CRS", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"46202", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Indiana Univ. School of Medicine, Infectious Disease Research Clinic", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Tulane Hemophilia Treatment Ctr.", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"21287", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Adult AIDS CRS", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"02114", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Massachusetts General Hospital ACTG CRS", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"02118", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Bmc Actg Crs", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Beth Israel Deaconess - East Campus A0102 CRS", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Beth Israel Deaconess Med. Ctr., ACTG CRS", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"city"=>"Minneapolis", "state"=>"Minnesota", "country"=>"United States", "facility"=>"University of Minnesota, ACTU", "geoPoint"=>{"lat"=>44.97997, "lon"=>-93.26384}}, {"city"=>"Saint Louis", "state"=>"Missouri", "country"=>"United States", "facility"=>"St. Louis ConnectCare, Infectious Diseases Clinic", "geoPoint"=>{"lat"=>38.62727, "lon"=>-90.19789}}, {"city"=>"Saint Louis", "state"=>"Missouri", "country"=>"United States", "facility"=>"Washington U CRS", "geoPoint"=>{"lat"=>38.62727, "lon"=>-90.19789}}, {"city"=>"Omaha", "state"=>"Nebraska", "country"=>"United States", "facility"=>"Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.", "geoPoint"=>{"lat"=>41.25626, "lon"=>-95.94043}}, {"zip"=>"14215", "city"=>"Buffalo", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY - Buffalo, Erie County Medical Ctr.", "geoPoint"=>{"lat"=>42.88645, "lon"=>-78.87837}}, {"zip"=>"10016", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"NY Univ. HIV/AIDS CRS", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10021", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Cornell University A2201", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"14642", "city"=>"Rochester", "state"=>"New York", "country"=>"United States", "facility"=>"Univ. of Rochester ACTG CRS", "geoPoint"=>{"lat"=>43.15478, "lon"=>-77.61556}}, {"zip"=>"27599", "city"=>"Chapel Hill", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Unc Aids Crs", "geoPoint"=>{"lat"=>35.9132, "lon"=>-79.05584}}, {"zip"=>"28203", "city"=>"Charlotte", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Carolinas HealthCare System, Carolinas Med. Ctr.", "geoPoint"=>{"lat"=>35.22709, "lon"=>-80.84313}}, {"zip"=>"27401", "city"=>"Greensboro", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Regional Center for Infectious Disease, Wendover Medical Center CRS", "geoPoint"=>{"lat"=>36.07264, "lon"=>-79.79198}}, {"zip"=>"45267", "city"=>"Cincinnati", "state"=>"Ohio", "country"=>"United States", "facility"=>"Univ. of Cincinnati CRS", "geoPoint"=>{"lat"=>39.12713, "lon"=>-84.51435}}, {"city"=>"Cleveland", "state"=>"Ohio", "country"=>"United States", "facility"=>"Case CRS", "geoPoint"=>{"lat"=>41.4995, "lon"=>-81.69541}}, {"city"=>"Columbus", "state"=>"Ohio", "country"=>"United States", "facility"=>"The Ohio State Univ. AIDS CRS", "geoPoint"=>{"lat"=>39.96118, "lon"=>-82.99879}}, {"zip"=>"19104", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Hosp. of the Univ. of Pennsylvania CRS", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"98122", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"University of Washington AIDS CRS", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}, {"city"=>"San Juan", "country"=>"Puerto Rico", "facility"=>"Puerto Rico-AIDS CRS", "geoPoint"=>{"lat"=>18.46633, "lon"=>-66.10572}}, {"city"=>"Mbeya", "country"=>"Tanzania", "facility"=>"Mbeya Med. Research Program, Mbeya Referral Hosp. CRS", "geoPoint"=>{"lat"=>-8.9, "lon"=>33.45}}], "overallOfficials"=>[{"name"=>"Katzenstein D", "role"=>"STUDY_CHAIR"}, {"name"=>"Hammer S", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
