Nctid:
NCT00000788
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D002177", "term"=>"Candidiasis"}], "ancestors"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D009181", "term"=>"Mycoses"}, {"id"=>"D001423", "term"=>"Bacterial Infections and Mycoses"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"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", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M5437", "name"=>"Candidiasis", "asFound"=>"Candidiasis", "relevance"=>"HIGH"}, {"id"=>"M3735", "name"=>"AIDS-Related Complex", "relevance"=>"LOW"}, {"id"=>"M12136", "name"=>"Mycoses", "relevance"=>"LOW"}, {"id"=>"M4722", "name"=>"Bacterial Infections", "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"=>"D015725", "term"=>"Fluconazole"}, {"id"=>"D008691", "term"=>"Methadone"}], "ancestors"=>[{"id"=>"D000701", "term"=>"Analgesics, Opioid"}, {"id"=>"D009294", "term"=>"Narcotics"}, {"id"=>"D002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000700", "term"=>"Analgesics"}, {"id"=>"D018689", "term"=>"Sensory System Agents"}, {"id"=>"D018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D000996", "term"=>"Antitussive Agents"}, {"id"=>"D019141", "term"=>"Respiratory System Agents"}, {"id"=>"D000935", "term"=>"Antifungal Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D058888", "term"=>"14-alpha Demethylase Inhibitors"}, {"id"=>"D065607", "term"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D065088", "term"=>"Steroid Synthesis Inhibitors"}, {"id"=>"D006727", "term"=>"Hormone Antagonists"}, {"id"=>"D006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D065688", "term"=>"Cytochrome P-450 CYP2C9 Inhibitors"}, {"id"=>"D065689", "term"=>"Cytochrome P-450 CYP2C19 Inhibitors"}], "browseLeaves"=>[{"id"=>"M11671", "name"=>"Methadone", "asFound"=>"Aneuploidy", "relevance"=>"HIGH"}, {"id"=>"M18296", "name"=>"Fluconazole", "asFound"=>"Premature", "relevance"=>"HIGH"}, {"id"=>"M4254", "name"=>"Antifungal Agents", "relevance"=>"LOW"}, {"id"=>"M6252", "name"=>"Clotrimazole", "relevance"=>"LOW"}, {"id"=>"M11796", "name"=>"Miconazole", "relevance"=>"LOW"}, {"id"=>"M4033", "name"=>"Analgesics, Opioid", "relevance"=>"LOW"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}, {"id"=>"M12245", "name"=>"Narcotics", "relevance"=>"LOW"}, {"id"=>"M13570", "name"=>"Phenylpropanolamine", "relevance"=>"LOW"}, {"id"=>"M9238", "name"=>"Guaifenesin", "relevance"=>"LOW"}, {"id"=>"M186319", "name"=>"Chlorpheniramine, phenylpropanolamine drug combination", "relevance"=>"LOW"}, {"id"=>"M4312", "name"=>"Antitussive Agents", "relevance"=>"LOW"}, {"id"=>"M21137", "name"=>"Respiratory System Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M30537", "name"=>"Cytochrome P-450 Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Antitussive Agents", "abbrev"=>"AnTuAg"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Respiratory System Agents", "abbrev"=>"Resp"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Anti-Obesity Agents", "abbrev"=>"AnObAg"}, {"name"=>"Vasoconstrictor Agents", "abbrev"=>"VaCoAg"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"count"=>24}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1994-06", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-27", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-11-03", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Methadone", "Drug Interactions", "Drug Therapy, Combination", "Fluconazole", "Antifungal Agents", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex"], "conditions"=>["Candidiasis", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"9663180", "type"=>"BACKGROUND", "citation"=>"Cobb MN, Desai J, Brown LS Jr, Zannikos PN, Rainey PM. The effect of fluconazole on the clinical pharmacokinetics of methadone. Clin Pharmacol Ther. 1998 Jun;63(6):655-62. doi: 10.1016/S0009-9236(98)90089-3."}]}, "descriptionModule"=>{"briefSummary"=>"To evaluate the pharmacokinetics and safety of concomitant administration of methadone and fluconazole.\n\nInjection drug users constitute the second largest subset of the U.S. population at risk for HIV infection and AIDS-associated mortality. Narcotic addiction is often treated by use of methadone. Fluconazole has been shown to be highly effective in treating symptomatic mucosal candidiasis, but it is unknown whether fluconazole affects methadone metabolism, which could result in symptoms of methadone withdrawal or overdose in patients taking the drugs in combination.", "detailedDescription"=>"Injection drug users constitute the second largest subset of the U.S. population at risk for HIV infection and AIDS-associated mortality. Narcotic addiction is often treated by use of methadone. Fluconazole has been shown to be highly effective in treating symptomatic mucosal candidiasis, but it is unknown whether fluconazole affects methadone metabolism, which could result in symptoms of methadone withdrawal or overdose in patients taking the drugs in combination.\n\nPatients are randomized to receive methadone plus either fluconazole or placebo in clinic daily for 16 days. Study drugs are administered as close to 8 AM as possible. Patients must visit the Fort Greene clinic on study days 1, 2, 15, and 16; they may receive treatment at their home clinics on days 3 through 14."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Antiretroviral therapy.\n* Intermittent acetaminophen, aspirin, and ibuprofen.\n\nPatients must have:\n\n* CD4 count \\>= 250 cells/mm3 within 3 months prior to study entry.\n* Received a stable dose of methadone for a minimum of 30 days prior to study entry.\n* Negative urine toxicology screen (except for methadone or methadone metabolites) within 14 days prior to study entry.\n* Reasonably good health.\n* Life expectancy of at least 6 months.\n* Ability and willingness to comply with protocol requirements.\n\nNOTE:\n\n* Patients will be recruited from the methadone maintenance treatment program currently administered by Addiction Research and Treatment Corporation. Enrollment of women is encouraged.\n\nNOTE:\n\n* Patients who are currently enrolled in CPCRA treatment and prophylaxis trials are eligible for this study provided they have been permanently removed from study drug on the other protocol.\n\nPrior Medication:\n\nRequired:\n\n* Stable dose of methadone for a minimum of 30 days prior to study entry.\n\nAllowed:\n\n* Prior antiretroviral therapy (dose should be stable for 14 days prior to study entry).\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Known sensitivity to azoles, methadone, and other opiate narcotics.\n\nConcurrent Medication:\n\nExcluded:\n\n* Amiodarone.\n* Anesthetics, general.\n* Barbiturates.\n* Carbamazepine.\n* Cimetidine.\n* Ciprofloxacin.\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* MAO inhibitors.\n* Methoxsalen.\n* Nafcillin.\n* Narcotic analgesics.\n* Naringenin.\n* Norethindrone.\n* Omeprazole.\n* Pentazocine.\n* Phenothiazines.\n* Phenytoin.\n* Quinidine.\n* Ranitidine.\n* Rifabutin.\n* Rifampin.\n* Sedative hypnotics.\n* Sulfaphenazole.\n* Tranquilizers.\n* Tricyclic antidepressants.\n* Troleandomycin.\n* Warfarin.\n\nPrior Medication:\n\nExcluded within 30 days prior to study entry:\n\n* Ketoconazole, fluconazole, or itraconazole.\n* Experimental drugs.\n\nAlcohol or illicit drug abuse."}, "identificationModule"=>{"nctId"=>"NCT00000788", "briefTitle"=>"A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone", "orgStudyIdInfo"=>{"id"=>"CPCRA 030"}, "secondaryIdInfos"=>[{"id"=>"11580", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Methadone hydrochloride", "type"=>"DRUG"}, {"name"=>"Fluconazole", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"11201", "city"=>"Brooklyn", "state"=>"New York", "country"=>"United States", "facility"=>"Addiction Research and Treatment Corp", "geoPoint"=>{"lat"=>40.6501, "lon"=>-73.94958}}], "overallOfficials"=>[{"name"=>"Cobb M", "role"=>"STUDY_CHAIR"}, {"name"=>"Letts A", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
