Nctid:
NCT00002244
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D015658", "term"=>"HIV Infections"}, {"id"=>"D000163", "term"=>"Acquired Immunodeficiency Syndrome"}], "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"}, {"id"=>"D012897", "term"=>"Slow Virus Diseases"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "asFound"=>"HIV Disease", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Disease", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"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"}, {"id"=>"M15700", "name"=>"Slow Virus Diseases", "relevance"=>"LOW"}, {"id"=>"T6034", "name"=>"Quality of Life", "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"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M21860", "name"=>"Pharmaceutical Solutions", "relevance"=>"LOW"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Pharmaceutical Solutions", "abbrev"=>"PhSol"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>240}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2001-03", "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"=>["Placebos", "Infusions, Intravenous", "Quality of Life", "Anti-HIV Agents", "tetrachlorodecaoxide"], "conditions"=>["HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to see if it is safe and effective to give WF10 to adults with late-stage HIV disease. WF10 is suspected to help the immune system fight infection and slow HIV disease progression.", "detailedDescription"=>"Patients are randomized to 1 of 2 treatment groups to receive 4 IV treatment cycles of either WF10 or control (physiological saline solution). Patients are monitored throughout the study for: a) clinical progression; b) number, duration, and cause of hospitalizations; c) quality of life; and d) density of CD38 antigen on CD8+ T cells. Patients receive treatment for 11 weeks but will continue to be followed for a maximum of 96 weeks. During the follow-up period, patients are evaluated initially at Week 18, then at Weeks 24, 36, and 48. If the study is continued beyond Week 48, follow-up visits are conducted at Weeks 72 and 96."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients may be eligible for this study if they:\n\n* Are HIV-positive.\n* Have a CD4 cell count of less than 50 cells/mm3 within 14 days prior to study entry.\n* Are at least 18 years old.\n* Have received anti-HIV drugs at some time in the past.\n* Agree to practice abstinence or use effective methods of birth control, including the pill, during the study.\n\nExclusion Criteria\n\nPatients will not be eligible for this study if they:\n\n* Are being treated for any form of cancer within 30 days of study entry.\n* Have ever received an HIV vaccine.\n* Have received steroids within 30 days prior to study entry. (Note: Testosterone is allowed.)\n* Have received certain medications, including anti-HIV treatments that are not approved by the FDA.\n* Have participated in another WF10 study.\n* Have an illness or any condition that might exclude them from this study.\n* Are pregnant or breast-feeding.\n* Abuse drugs or medications.\n* Received a blood transfusion within 45 days prior to study entry."}, "identificationModule"=>{"nctId"=>"NCT00002244", "briefTitle"=>"A Study to Evaluate the Safety and Effectiveness of WF10 Given to Patients With Late-Stage HIV Disease", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Pivotal Clinical Study Evaluating the Safety and Efficacy of WF10 (TCDO) Intravenous Solution in the Management of Patients With Late-Stage HIV Disease", "orgStudyIdInfo"=>{"id"=>"222C"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"WF10", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35294", "city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"Univ of Alabama at Birmingham", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"90048", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Tower Infectious Disease Med Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"946021018", "city"=>"Oakland", "state"=>"California", "country"=>"United States", "facility"=>"Highland Gen Hosp / San Francisco Gen Hosp", "geoPoint"=>{"lat"=>37.80437, "lon"=>-122.2708}}, {"zip"=>"94103", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"ViRx Inc", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"94110", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"UCSF - San Francisco Gen Hosp", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"20037", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"George Washington Univ Med Ctr", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"33136", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ of Miami School of Medicine", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"33602", "city"=>"Tampa", "state"=>"Florida", "country"=>"United States", "facility"=>"Hillsborough County Health Dept", "geoPoint"=>{"lat"=>27.94752, "lon"=>-82.45843}}, {"zip"=>"33609", "city"=>"Tampa", "state"=>"Florida", "country"=>"United States", "facility"=>"Ctr for Quality Care", "geoPoint"=>{"lat"=>27.94752, "lon"=>-82.45843}}, {"zip"=>"30308", "city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"AIDS Research Consortium of Atlanta", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"96816", "city"=>"Honolulu", "state"=>"Hawaii", "country"=>"United States", "facility"=>"Leahi Hosp / Univ of Hawaii", "geoPoint"=>{"lat"=>21.30694, "lon"=>-157.85833}}, {"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 Med Ctr / Section of Infectious Diseases", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"The CORE Ctr", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"52242", "city"=>"Iowa City", "state"=>"Iowa", "country"=>"United States", "facility"=>"Univ of Iowa Hosp & Clinic", "geoPoint"=>{"lat"=>41.66113, "lon"=>-91.53017}}, {"zip"=>"02118", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Boston Med Ctr / Clinical Research Office", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"48201", "city"=>"Detroit", "state"=>"Michigan", "country"=>"United States", "facility"=>"Univ Health Ctr", "geoPoint"=>{"lat"=>42.33143, "lon"=>-83.04575}}, {"zip"=>"55101", "city"=>"St. Paul", "state"=>"Minnesota", "country"=>"United States", "facility"=>"Regions Hosp", "geoPoint"=>{"lat"=>44.94441, "lon"=>-93.09327}}, {"zip"=>"64108", "city"=>"Kansas City", "state"=>"Missouri", "country"=>"United States", "facility"=>"Truman Med Ctr / Infectious Disease Clinic", "geoPoint"=>{"lat"=>39.09973, "lon"=>-94.57857}}, {"zip"=>"07114", "city"=>"Newark", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Newark Community Health Ctr", "geoPoint"=>{"lat"=>40.73566, "lon"=>-74.17237}}, {"zip"=>"87131", "city"=>"Albuquerque", "state"=>"New Mexico", "country"=>"United States", "facility"=>"Univ of New Mexico Health Science Center", "geoPoint"=>{"lat"=>35.08449, "lon"=>-106.65114}}, {"zip"=>"74114", "city"=>"Tulsa", "state"=>"Oklahoma", "country"=>"United States", "facility"=>"Associates in Med and Mental Health", "geoPoint"=>{"lat"=>36.15398, "lon"=>-95.99277}}, {"zip"=>"19102", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"MCP Hahnemann Univ", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"29414", "city"=>"Charleston", "state"=>"South Carolina", "country"=>"United States", "facility"=>"Ludwig Lettau Private Practice", "geoPoint"=>{"lat"=>32.77657, "lon"=>-79.93092}}, {"zip"=>"29206", "city"=>"Columbia", "state"=>"South Carolina", "country"=>"United States", "facility"=>"Burnside Clinic", "geoPoint"=>{"lat"=>34.00071, "lon"=>-81.03481}}, {"zip"=>"23666", "city"=>"Hampton", "state"=>"Virginia", "country"=>"United States", "facility"=>"Hampton Roads Med Specialists", "geoPoint"=>{"lat"=>37.02987, "lon"=>-76.34522}}, {"zip"=>"98101", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"Virginia Mason Research Center / Clinical Trial Unit", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}, {"city"=>"Vancouver", "state"=>"British Columbia", "country"=>"Canada", "facility"=>"St Paul's Hosp", "geoPoint"=>{"lat"=>49.24966, "lon"=>-123.11934}}, {"city"=>"Halifax", "state"=>"Nova Scotia", "country"=>"Canada", "facility"=>"QEII Health Science Centre", "geoPoint"=>{"lat"=>44.64533, "lon"=>-63.57239}}, {"city"=>"Ottawa", "state"=>"Ontario", "country"=>"Canada", "facility"=>"Ottawa General Hospital", "geoPoint"=>{"lat"=>45.41117, "lon"=>-75.69812}}, {"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"=>"Montreal Gen Hosp / Div of Clin Immuno and Allergy", "geoPoint"=>{"lat"=>45.50884, "lon"=>-73.58781}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"OXO Chemie", "class"=>"INDUSTRY"}}}}
