Nctid:
NCT00002150
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-04"}, "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"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"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"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M17920", "name"=>"Zidovudine", "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"=>200}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1996-03", "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"=>["Drug Therapy, Combination", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex", "Zidovudine", "MDL 28574"], "conditions"=>["HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"To characterize the safety and efficacy of fixed doses of MDL 28,574A administered alone and in combination with zidovudine ( AZT ) in patients with asymptomatic or mildly symptomatic HIV infection. To examine the demographic effects on population pharmacokinetics and pharmacodynamics of MDL 28,574A alone and in combination with AZT."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have:\n\n* HIV infection.\n* Asymptomatic or mildly symptomatic.\n* CD4 count 100 - 300 cells/mm3.\n\nPrior Medication:\n\nAllowed:\n\n* Prior antiretroviral agents for up to 6 months per agent.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following condition are excluded:\n\nUnable or unwilling to comply with study procedures.\n\nConcurrent Medication:\n\nExcluded:\n\n* Chemoprophylactic therapy for mycobacterial infection.\n* Any nonstudy prescription medications without approval of investigator.\n\nPatients with the following prior conditions are excluded:\n\n* History of grade 3 or 4 toxicity to \\<= 600 mg/day AZT.\n* History of intolerance to lactose.\n* Chronic diarrhea within 6 months prior to study entry.\n* Unexplained intermittent or chronic fever, defined as temperature \\>= 38.5 C for any 7 days within the 30 days prior to study entry.\n\nPrior Medication:\n\nExcluded:\n\n* Antiretroviral therapy within 2 weeks prior to study entry.\n* Prior HIV vaccines.\n* Biological response modifiers within 30 days prior to study entry.\n* Prior foscarnet.\n* Any investigational drug with a washout \\< 5 half-lives prior to study entry.\n* Any medications known to alter renal, hepatic, or hematologic / immunologic function (such as barbiturates, phenothiazines, cimetidine, immunomodulators, etc.) within 14 days prior to study entry.\n\nRecent history of alcohol and/or drug abuse."}, "identificationModule"=>{"nctId"=>"NCT00002150", "briefTitle"=>"A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients", "orgStudyIdInfo"=>{"id"=>"221B"}, "secondaryIdInfos"=>[{"id"=>"028574PR0003"}, {"id"=>"NDPR0003"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Celgosivir hydrochloride", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"366880002", "city"=>"Mobile", "state"=>"Alabama", "country"=>"United States", "facility"=>"Clinical Investigations Health Services", "geoPoint"=>{"lat"=>30.69436, "lon"=>-88.04305}}, {"zip"=>"90211", "city"=>"Beverly Hills", "state"=>"California", "country"=>"United States", "facility"=>"California Clinical Trials Med Group", "geoPoint"=>{"lat"=>34.07362, "lon"=>-118.40036}}, {"zip"=>"90027", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Southwest Community Based AIDS Treatment Group - COMBAT", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"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 / Hershey Med Ctr", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"33146", "city"=>"Coral Gables", "state"=>"Florida", "country"=>"United States", "facility"=>"Community Research Initiative of South Florida", "geoPoint"=>{"lat"=>25.72149, "lon"=>-80.26838}}, {"zip"=>"33316", "city"=>"Fort Lauderdale", "state"=>"Florida", "country"=>"United States", "facility"=>"Independent Investigator", "geoPoint"=>{"lat"=>26.12231, "lon"=>-80.14338}}, {"zip"=>"33316", "city"=>"Fort Lauderdale", "state"=>"Florida", "country"=>"United States", "facility"=>"North Broward Hosp District", "geoPoint"=>{"lat"=>26.12231, "lon"=>-80.14338}}, {"zip"=>"34239", "city"=>"Sarasota", "state"=>"Florida", "country"=>"United States", "facility"=>"Clinical Research Ctr", "geoPoint"=>{"lat"=>27.33643, "lon"=>-82.53065}}, {"zip"=>"32960", "city"=>"Vero Beach", "state"=>"Florida", "country"=>"United States", "facility"=>"Independent Investigator", "geoPoint"=>{"lat"=>27.63864, "lon"=>-80.39727}}, {"zip"=>"60657", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Ctr for Special Immunology", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"462025250", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Indiana Univ Hosp", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"zip"=>"67214", "city"=>"Wichita", "state"=>"Kansas", "country"=>"United States", "facility"=>"Univ of Kansas School of Medicine", "geoPoint"=>{"lat"=>37.69224, "lon"=>-97.33754}}, {"zip"=>"48201", "city"=>"Detroit", "state"=>"Michigan", "country"=>"United States", "facility"=>"Univ Health Ctr", "geoPoint"=>{"lat"=>42.33143, "lon"=>-83.04575}}, {"zip"=>"64132", "city"=>"Kansas City", "state"=>"Missouri", "country"=>"United States", "facility"=>"Antibiotic Research Associates", "geoPoint"=>{"lat"=>39.09973, "lon"=>-94.57857}}, {"zip"=>"071032842", "city"=>"Newark", "state"=>"New Jersey", "country"=>"United States", "facility"=>"North Jersey Community Research Initiative", "geoPoint"=>{"lat"=>40.73566, "lon"=>-74.17237}}, {"zip"=>"14620", "city"=>"Rochester", "state"=>"New York", "country"=>"United States", "facility"=>"Community Health Network", "geoPoint"=>{"lat"=>43.15478, "lon"=>-77.61556}}, {"zip"=>"117948153", "city"=>"Stony Brook", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY / Health Sciences Ctr at Stony Brook", "geoPoint"=>{"lat"=>40.92565, "lon"=>-73.14094}}, {"zip"=>"43608", "city"=>"Toledo", "state"=>"Ohio", "country"=>"United States", "facility"=>"Infectious Disease Associates", "geoPoint"=>{"lat"=>41.66394, "lon"=>-83.55521}}, {"zip"=>"18840", "city"=>"Sayre", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Guthrie Clinic", "geoPoint"=>{"lat"=>41.97896, "lon"=>-76.5155}}, {"zip"=>"752359103", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"Univ of Texas Southwestern Med Ctr of Dallas", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"775550835", "city"=>"Galveston", "state"=>"Texas", "country"=>"United States", "facility"=>"Univ TX Galveston Med Branch", "geoPoint"=>{"lat"=>29.30135, "lon"=>-94.7977}}, {"zip"=>"77006", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Houston Clinical Research Network", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Hoechst Marion Roussel", "class"=>"INDUSTRY"}}}}
