Nctid:
NCT00001065
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000002177", "term"=>"Candidiasis"}, {"id"=>"D000002180", "term"=>"Candidiasis, Oral"}], "ancestors"=>[{"id"=>"D000009181", "term"=>"Mycoses"}, {"id"=>"D000001423", "term"=>"Bacterial Infections and Mycoses"}, {"id"=>"D000009059", "term"=>"Mouth Diseases"}, {"id"=>"D000009057", "term"=>"Stomatognathic Diseases"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M12136", "name"=>"Mycoses", "relevance"=>"LOW"}, {"id"=>"M5437", "name"=>"Candidiasis", "asFound"=>"Candidiasis", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M5440", "name"=>"Candidiasis, Oral", "asFound"=>"Candidiasis, Oral", "relevance"=>"HIGH"}, {"id"=>"M3735", "name"=>"AIDS-Related Complex", "relevance"=>"LOW"}, {"id"=>"M4722", "name"=>"Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M4721", "name"=>"Bacterial Infections and Mycoses", "relevance"=>"LOW"}, {"id"=>"M12019", "name"=>"Mouth Diseases", "relevance"=>"LOW"}, {"id"=>"M12017", "name"=>"Stomatognathic 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"}, {"name"=>"Mouth and Tooth Diseases", "abbrev"=>"BC07"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000000666", "term"=>"Amphotericin B"}, {"id"=>"C000068538", "term"=>"Liposomal amphotericin B"}], "ancestors"=>[{"id"=>"D000000563", "term"=>"Amebicides"}, {"id"=>"D000000981", "term"=>"Antiprotozoal Agents"}, {"id"=>"D000000977", "term"=>"Antiparasitic Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000000900", "term"=>"Anti-Bacterial Agents"}, {"id"=>"D000000935", "term"=>"Antifungal Agents"}], "browseLeaves"=>[{"id"=>"M4002", "name"=>"Amphotericin B", "asFound"=>"Mobile app", "relevance"=>"HIGH"}, {"id"=>"M255436", "name"=>"Liposomal amphotericin B", "asFound"=>"Mobile app", "relevance"=>"HIGH"}, {"id"=>"M18296", "name"=>"Fluconazole", "relevance"=>"LOW"}, {"id"=>"M3904", "name"=>"Amebicides", "relevance"=>"LOW"}, {"id"=>"M4298", "name"=>"Antiprotozoal Agents", "relevance"=>"LOW"}, {"id"=>"M4294", "name"=>"Antiparasitic Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M6252", "name"=>"Clotrimazole", "relevance"=>"LOW"}, {"id"=>"M11796", "name"=>"Miconazole", "relevance"=>"LOW"}, {"id"=>"M4254", "name"=>"Antifungal Agents", "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"=>70}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1998-04", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-28", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-11-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Administration, Oral", "Acquired Immunodeficiency Syndrome", "Amphotericin B", "AIDS-Related Complex", "Candidiasis, Oral", "Suspensions"], "conditions"=>["Candidiasis, Oral", "HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"To assess response and toxicity in patients with fluconazole-resistant oral candidiasis ( thrush ) when given initial induction with amphotericin B oral suspension.\n\nExperience with amphotericin B oral suspension for drug-sensitive thrush in HIV-infected patients is limited but encouraging.", "detailedDescription"=>"Experience with amphotericin B oral suspension for drug-sensitive thrush in HIV-infected patients is limited but encouraging.\n\nPatients swish and swallow amphotericin B oral suspension after each meal and at bedtime for 14 days, at which time they are deemed a responder, nonresponder, or failure to induction therapy. Responders receive maintenance twice daily, while nonresponders receive 14 further days of initial induction. Failures discontinue the study. Responders after 28 days of induction are placed on maintenance. After successful completion of initial induction, patients remain on study for 6 months."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"13 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have:\n\n* HIV infection OR diagnosis of AIDS.\n* Diffuse oral candidiasis, symptomatic or asymptomatic, that is resistant to fluconazole.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Current symptoms of esophageal candidiasis unless there are negative endoscopic visualization and biopsy for Candida or related yeasts.\n* Perioral lesions only (e.g., angular stomatitis, perleche).\n* Inability to swish and swallow oral solution.\n* Inability to tolerate further oral therapy for thrush.\n\nConcurrent Medication:\n\nExcluded:\n\n* Fluconazole.\n* Itraconazole.\n* Ketoconazole.\n* Flucytosine.\n* Intravenous amphotericin or other non-study formulations.\n* Nystatin.\n* Clotrimazole.\n* Other investigational antifungal agents.\n* Systemic cytotoxic chemotherapy for malignancy.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Radiation therapy to the mouth, neck, or chest.\n\nPatients with the following prior conditions are excluded:\n\n* Esophageal candidiasis, proven or presumptive, occurring since fluconazole failure.\n* Successful treatment of thrush with fluconazole at \\<= 200 mg/day after original treatment failure.\n* History of oral candidiasis that recurred or persisted despite IV amphotericin B given once or more weekly.\n* History of anaphylaxis to amphotericin B.\n* History of hypersensitivity to components in amphotericin B oral suspension.\n\nPrior Medication:\n\nExcluded within 6 weeks prior to study entry:\n\n* Cytotoxic therapy for malignancy.\n* Corticosteroids at higher than replacement doses."}, "identificationModule"=>{"nctId"=>"NCT00001065", "briefTitle"=>"A Study of Amphotericin B in the Treatment of Fungal Infections of the Mouth in HIV-Infected Patients Who Have Not Had Success With Fluconazole", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Phase II Trial of Amphotericin B Oral Suspension for Fluconazole-Resistant Oral Candidiasis in HIV-Infected Patients", "orgStudyIdInfo"=>{"id"=>"ACTG 295"}, "secondaryIdInfos"=>[{"id"=>"11271", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Amphotericin B", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35294", "city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"Alabama Therapeutics CRS", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"USC CRS", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"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"=>"20059", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Howard University Hosp., Div. of Infectious Diseases, ACTU", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ. of Miami AIDS CRS", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"The Ponce de Leon Ctr. CRS", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"96816", "city"=>"Honolulu", "state"=>"Hawaii", "country"=>"United States", "facility"=>"Queens Med. Ctr.", "geoPoint"=>{"lat"=>21.30694, "lon"=>-157.85833}}, {"zip"=>"96816", "city"=>"Honolulu", "state"=>"Hawaii", "country"=>"United States", "facility"=>"Univ. of Hawaii at Manoa, Leahi Hosp.", "geoPoint"=>{"lat"=>21.30694, "lon"=>-157.85833}}, {"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"=>"60640", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Weiss Memorial Hosp.", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"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}}, {"zip"=>"46202", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Indiana Univ. School of Medicine, Wishard Memorial", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"zip"=>"46202", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Methodist Hosp. of Indiana", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"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}}, {"zip"=>"63112", "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}}, {"zip"=>"68198", "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"=>"10029", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Beth Israel Med. Ctr. (Mt. Sinai)", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"NY Univ. HIV/AIDS CRS", "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"=>"45267", "city"=>"Cincinnati", "state"=>"Ohio", "country"=>"United States", "facility"=>"Univ. of Cincinnati CRS", "geoPoint"=>{"lat"=>39.12713, "lon"=>-84.51435}}, {"zip"=>"43210", "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}}, {"zip"=>"00936", "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"=>"Zingman BS", "role"=>"STUDY_CHAIR"}, {"name"=>"Wheat LJ", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Bristol-Myers Squibb", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
