Nctid:
NCT00000826
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000003141", "term"=>"Communicable Diseases"}, {"id"=>"D000009181", "term"=>"Mycoses"}, {"id"=>"D000001424", "term"=>"Bacterial Infections"}], "ancestors"=>[{"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000001423", "term"=>"Bacterial Infections and Mycoses"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M12136", "name"=>"Mycoses", "asFound"=>"Mycosis", "relevance"=>"HIGH"}, {"id"=>"M4722", "name"=>"Bacterial Infections", "asFound"=>"Bacterial Infections", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M12825", "name"=>"Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M19410", "name"=>"AIDS-Related Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M3735", "name"=>"AIDS-Related Complex", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M4721", "name"=>"Bacterial Infections and Mycoses", "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"=>{"meshes"=>[{"id"=>"D000017291", "term"=>"Clarithromycin"}, {"id"=>"D000003622", "term"=>"Dapsone"}, {"id"=>"D000017828", "term"=>"Rifabutin"}, {"id"=>"D000015662", "term"=>"Trimethoprim, Sulfamethoxazole Drug Combination"}, {"id"=>"D000015725", "term"=>"Fluconazole"}, {"id"=>"D000014295", "term"=>"Trimethoprim"}, {"id"=>"D000013420", "term"=>"Sulfamethoxazole"}], "ancestors"=>[{"id"=>"D000000900", "term"=>"Anti-Bacterial Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000011500", "term"=>"Protein Synthesis Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000065692", "term"=>"Cytochrome P-450 CYP3A Inhibitors"}, {"id"=>"D000065607", "term"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"id"=>"D000000935", "term"=>"Antifungal Agents"}, {"id"=>"D000058888", "term"=>"14-alpha Demethylase Inhibitors"}, {"id"=>"D000065088", "term"=>"Steroid Synthesis Inhibitors"}, {"id"=>"D000006727", "term"=>"Hormone Antagonists"}, {"id"=>"D000006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000065688", "term"=>"Cytochrome P-450 CYP2C9 Inhibitors"}, {"id"=>"D000065689", "term"=>"Cytochrome P-450 CYP2C19 Inhibitors"}, {"id"=>"D000000892", "term"=>"Anti-Infective Agents, Urinary"}, {"id"=>"D000000962", "term"=>"Antimalarials"}, {"id"=>"D000000981", "term"=>"Antiprotozoal Agents"}, {"id"=>"D000000977", "term"=>"Antiparasitic Agents"}, {"id"=>"D000005493", "term"=>"Folic Acid Antagonists"}, {"id"=>"D000018726", "term"=>"Anti-Dyskinesia Agents"}, {"id"=>"D000065687", "term"=>"Cytochrome P-450 CYP2C8 Inhibitors"}, {"id"=>"D000007917", "term"=>"Leprostatic Agents"}, {"id"=>"D000000904", "term"=>"Antibiotics, Antitubercular"}, {"id"=>"D000000995", "term"=>"Antitubercular Agents"}], "browseLeaves"=>[{"id"=>"M19585", "name"=>"Clarithromycin", "asFound"=>"Planning", "relevance"=>"HIGH"}, {"id"=>"M17047", "name"=>"Trimethoprim", "asFound"=>"Decision aid", "relevance"=>"HIGH"}, {"id"=>"M16206", "name"=>"Sulfamethoxazole", "asFound"=>"Advanced Cancer", "relevance"=>"HIGH"}, {"id"=>"M18296", "name"=>"Fluconazole", "asFound"=>"5-fluorouracil", "relevance"=>"HIGH"}, {"id"=>"M18253", "name"=>"Trimethoprim, Sulfamethoxazole Drug Combination", "asFound"=>"Joint range of motion", "relevance"=>"HIGH"}, {"id"=>"M6824", "name"=>"Dapsone", "asFound"=>"Polycystic Ovary", "relevance"=>"HIGH"}, {"id"=>"M20019", "name"=>"Rifabutin", "asFound"=>"Cilostazol", "relevance"=>"HIGH"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M30564", "name"=>"Cytochrome P-450 CYP3A Inhibitors", "relevance"=>"LOW"}, {"id"=>"M30537", "name"=>"Cytochrome P-450 Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M6252", "name"=>"Clotrimazole", "relevance"=>"LOW"}, {"id"=>"M11796", "name"=>"Miconazole", "relevance"=>"LOW"}, {"id"=>"M4254", "name"=>"Antifungal Agents", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}, {"id"=>"M4280", "name"=>"Antimalarials", "relevance"=>"LOW"}, {"id"=>"M4298", "name"=>"Antiprotozoal Agents", "relevance"=>"LOW"}, {"id"=>"M4294", "name"=>"Antiparasitic Agents", "relevance"=>"LOW"}, {"id"=>"M17546", "name"=>"Vitamin B Complex", "relevance"=>"LOW"}, {"id"=>"M8618", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"M8619", "name"=>"Folic Acid Antagonists", "relevance"=>"LOW"}, {"id"=>"M4311", "name"=>"Antitubercular Agents", "relevance"=>"LOW"}, {"id"=>"M4224", "name"=>"Antibiotics, Antitubercular", "relevance"=>"LOW"}, {"id"=>"T447", "name"=>"Folinic Acid", "relevance"=>"LOW"}, {"id"=>"T446", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"T448", "name"=>"Folate", "relevance"=>"LOW"}, {"id"=>"T475", "name"=>"Vitamin B9", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Dyskinesia Agents", "abbrev"=>"AnDyAg"}, {"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>48}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1999-05", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-27", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-10-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Rifabutin", "Trimethoprim-Sulfamethoxazole Combination", "AIDS-Related Opportunistic Infections", "Dapsone", "Drug Interactions", "Fluconazole", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex", "Clarithromycin", "Sulfamethoxazole-Trimethoprim"], "conditions"=>["Bacterial Infections", "Mycoses", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"11362422", "type"=>"BACKGROUND", "citation"=>"Cheng B. Preventing opportunistic infections. PI Perspect. 1995 May;(no 16):14-5."}, {"pmid"=>"15470330", "type"=>"RESULT", "citation"=>"Winter HR, Trapnell CB, Slattery JT, Jacobson M, Greenspan DL, Hooton TM, Unadkat JD. The effect of clarithromycin, fluconazole, and rifabutin on sulfamethoxazole hydroxylamine formation in individuals with human immunodeficiency virus infection (AACTG 283). Clin Pharmacol Ther. 2004 Oct;76(4):313-22. doi: 10.1016/j.clpt.2004.06.002."}]}, "descriptionModule"=>{"briefSummary"=>"To determine the effects of fluconazole and either rifabutin or clarithromycin, alone and in combination, on the pharmacokinetics of first sulfamethoxazole-trimethoprim and then dapsone in HIV-infected patients.\n\nAlthough prophylaxis for more than one opportunistic infection is emerging as a common clinical practice in patients with advanced HIV disease, little is known about possible adverse drug interactions. The need exists to define pharmacokinetics and pharmacodynamic adverse interactions of the many combination prophylactic regimens that may be prescribed.", "detailedDescription"=>"Although prophylaxis for more than one opportunistic infection is emerging as a common clinical practice in patients with advanced HIV disease, little is known about possible adverse drug interactions. The need exists to define pharmacokinetics and pharmacodynamic adverse interactions of the many combination prophylactic regimens that may be prescribed.\n\nIn Part A, patients receive sulfamethoxazole-trimethoprim (SMX/TMP) alone for 2 weeks, then in combination with fluconazole, rifabutin, or both drugs, each over 2-week periods in a randomly assigned order. Patients in Part B receive the same regimens except with clarithromycin substituted for rifabutin. In Part C, patients receive dapsone alone for 2 weeks, then in combination with fluconazole, rifabutin, or both drugs in the same manner as in Part A. Part D patients receive the same regimen as those in Part C, except with clarithromycin substituted for rifabutin. Patients are followed every 2 weeks."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Antiretroviral therapy provided patient has been on a stable dose for at least 4 weeks prior to study entry.\n* Methadone for drug abuse programs provided patient has been on a stable dose for at least 4 weeks prior to the study.\n\nPatients must have:\n\n* HIV infection.\n* CD4 count \\>= 200 cells/mm3.\n* No active opportunistic infection.\n\nPrior Medication:\n\nAllowed:\n\n* Antiretroviral therapy.\n* Methadone for drug abuse therapy.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Suspicion of gastrointestinal malabsorption problems (at discretion of investigator).\n* Known hypersensitivity to dapsone, SMX, or other sulfonamides, trimethoprim, clarithromycin, rifabutin or other rifamycins, fluconazole, or other azoles.\n* G-6-PD deficiency or methemoglobinemia (in Part C and D patients only).\n\nConcurrent Medication:\n\nExcluded:\n\n* Cytolytic agents.\n* Amiodarone.\n* Anesthetics, general.\n* Astemizole.\n* Azithromycin.\n* Barbiturates.\n* Carbamazepine.\n* Cimetidine.\n* Ciprofloxacin.\n* Cisapride.\n* Clarithromycin (except as required on study).\n* Clotrimazole.\n* Dexamethasone.\n* Disulfiram.\n* Erythromycin.\n* Fluoroquinolones.\n* Fluoxetine.\n* Gestodene.\n* Hydrochlorothiazide.\n* Hypoglycemics, oral.\n* Isoniazid.\n* Itraconazole.\n* Ketoconazole.\n* Levomepromazine.\n* Loratadine.\n* MAO inhibitors.\n* Methoxsalen.\n* Miconazole.\n* Nafcillin.\n* Narcotic analgesics.\n* Naringenin.\n* Nifedipine.\n* Norethindrone.\n* Pentazocine.\n* Phenothiazines.\n* Phenytoin.\n* Protease inhibitors.\n* Quinidine.\n* Ranitidine.\n* Rifabutin (except as required on study).\n* Rifampin.\n* Sedative hypnotics.\n* Sulfaphenazole.\n* Terfenadine.\n* Tranquilizers (unless allowed by investigator).\n* Tricyclic and tetracyclic antidepressants.\n* Troleandomycin.\n* Warfarin.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Radiation therapy.\n\nPrior Medication:\n\nExcluded:\n\n* Cytolytic agents within 5 years prior to study entry.\n* Rifabutin and/or rifampin within 4 weeks prior to study entry.\n* Fluconazoles or other azoles within 4 weeks prior to study entry.\n* Glutathione, glutathione precursors, or related prodrugs within 2 weeks prior to study entry.\n\nExcluded within 72 hours prior to study entry:\n\n* Amiodarone.\n* Anesthetics, general.\n* Astemizole.\n* Azithromycin.\n* Cimetidine.\n* Ciprofloxacin.\n* Cisapride.\n* Clarithromycin.\n* Dexamethasone.\n* Disulfiram.\n* Erythromycin.\n* Fluoroquinolones.\n* Fluoxetine.\n* Hydrochlorothiazide.\n* Hypoglycemics, oral.\n* Isoniazid.\n* Levomepromazine.\n* Loratadine.\n* MAO inhibitors.\n* Methoxsalen.\n* Nafcillin.\n* Narcotic analgesics.\n* Naringenin.\n* Nifedipine.\n* Norethindrone.\n* Pentazocine.\n* Phenothiazines.\n* Phenytoin.\n* Protease inhibitors.\n* Quinidine.\n* Ranitidine.\n* Sedative hypnotics.\n* Sulfaphenazole.\n* Terfenadine.\n* Tranquilizers (unless allowed by investigator).\n* Troleandomycin.\n* Warfarin.\n\nExcluded within 4 weeks prior to study entry:\n\n* Barbiturates.\n* Carbamazepine.\n* Clotrimazole.\n* Gestodene.\n* Itraconazole.\n* Ketoconazole.\n* Miconazole.\n* Omeprazole.\n* Rifabutin.\n* Rifampin.\n* Tricyclic and tetracyclic antidepressants.\n\nPrior Treatment:\n\nExcluded:\n\n* Blood transfusion within 1 week prior to study entry.\n* Radiation therapy within 5 years prior to study entry.\n\nActive drug or alcohol abuse or dependence that would preclude completion of study."}, "identificationModule"=>{"nctId"=>"NCT00000826", "briefTitle"=>"Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole and Dapsone and Their Hydroxylamine Metabolites", "orgStudyIdInfo"=>{"id"=>"ACTG 283"}, "secondaryIdInfos"=>[{"id"=>"11259", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Clarithromycin", "type"=>"DRUG"}, {"name"=>"Rifabutin", "type"=>"DRUG"}, {"name"=>"Sulfamethoxazole-Trimethoprim", "type"=>"DRUG"}, {"name"=>"Dapsone", "type"=>"DRUG"}, {"name"=>"Fluconazole", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Ucsf Aids Crs", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"98122", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"University of Washington AIDS CRS", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}], "overallOfficials"=>[{"name"=>"Unadkat J", "role"=>"STUDY_CHAIR"}, {"name"=>"Trapnell CB", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
