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Home > "A" Clinical Trials Conditions > A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone  A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone
A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone
For Condition: Candidiasis,HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To evaluate the pharmacokinetics and safety of concomitant administration of methadone and fluconazole. 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.
Details: 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. Patients 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.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Antiretroviral therapy. - Intermittent acetaminophen, aspirin, and ibuprofen. Patients must have: - CD4 count >= 250 cells/mm3 within 3 months prior to study entry. - Received a stable dose of methadone for a minimum of 30 days prior to study entry. - Negative urine toxicology screen (except for methadone or methadone metabolites) within 14 days prior to study entry. - Reasonably good health. - Life expectancy of at least 6 months. - Ability and willingness to comply with protocol requirements. NOTE: - Patients will be recruited from the methadone maintenance treatment program currently administered by Addiction Research and Treatment Corporation. Enrollment of women is encouraged. NOTE: - 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. Prior Medication: Required: - Stable dose of methadone for a minimum of 30 days prior to study entry. Allowed: - Prior antiretroviral therapy (dose should be stable for 14 days prior to study entry). Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Known sensitivity to azoles, methadone, and other opiate narcotics. Concurrent Medication: Excluded: - Amiodarone. - Anesthetics, general. - Barbiturates. - Carbamazepine. - Cimetidine. - Ciprofloxacin. - Dexamethasone. - Disulfiram. - Erythromycin. - Fluoroquinolones. - Fluoxetine. - Gestodene. - Hydrochlorothiazide. - Hypoglycemics, oral. - Isoniazid. - Itraconazole. - Ketoconazole. - Levomepromazine. - MAO inhibitors. - Methoxsalen. - Nafcillin. - Narcotic analgesics. - Naringenin. - Norethindrone. - Omeprazole. - Pentazocine. - Phenothiazines. - Phenytoin. - Quinidine. - Ranitidine. - Rifabutin. - Rifampin. - Sedative hypnotics. - Sulfaphenazole. - Tranquilizers. - Tricyclic antidepressants. - Troleandomycin. - Warfarin. Prior Medication: Excluded within 30 days prior to study entry: - Ketoconazole, fluconazole, or itraconazole. - Experimental drugs. Alcohol or illicit drug abuse.
Total Enrollment: 24
Location and Contact Information:
Overall Study Official:
CobbM, Study Chair,
Addiction Research and Treatment Corp
Brooklyn, New York, 11201
United States
Additional Information:
Study ID Numbers: CPCRA 030;
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000788
Other Hiv Infections Studies:
1. The Safety and Efficacy of Anidulafungin versus Comparator in Patients with Candidemia and Invasive Candidiasis
2. A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
3. The Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients with Invasive Candidiasis.
4. Caspofungin for the Treatment of Non-blood Candida Infections
5. Voriconazole to Prevent Systemic Fungal Infections in Children
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A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone
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