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Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites Clinical research trials and Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites. Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites clinical trial. Human subjects often get the best healthcare possible for their Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites  Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites
Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites
For Condition: Bacterial Infections,Mycoses,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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. 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.
Details: 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. In 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.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Antiretroviral therapy provided patient has been on a stable dose for at least 4 weeks prior to study entry. - Methadone for drug abuse programs provided patient has been on a stable dose for at least 4 weeks prior to the study. Patients must have: - HIV infection. - CD4 count >= 200 cells/mm3. - No active opportunistic infection. Prior Medication: Allowed: - Antiretroviral therapy. - Methadone for drug abuse therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Suspicion of gastrointestinal malabsorption problems (at discretion of investigator). - Known hypersensitivity to dapsone, SMX, or other sulfonamides, trimethoprim, clarithromycin, rifabutin or other rifamycins, fluconazole, or other azoles. - G-6-PD deficiency or methemoglobinemia (in Part C and D patients only). Concurrent Medication: Excluded: - Cytolytic agents. - Amiodarone. - Anesthetics, general. - Astemizole. - Azithromycin. - Barbiturates. - Carbamazepine. - Cimetidine. - Ciprofloxacin. - Cisapride. - Clarithromycin (except as required on study). - Clotrimazole. - Dexamethasone. - Disulfiram. - Erythromycin. - Fluoroquinolones. - Fluoxetine. - Gestodene. - Hydrochlorothiazide. - Hypoglycemics, oral. - Isoniazid. - Itraconazole. - Ketoconazole. - Levomepromazine. - Loratadine. - MAO inhibitors. - Methoxsalen. - Miconazole. - Nafcillin. - Narcotic analgesics. - Naringenin. - Nifedipine. - Norethindrone. - Pentazocine. - Phenothiazines. - Phenytoin. - Protease inhibitors. - Quinidine. - Ranitidine. - Rifabutin (except as required on study). - Rifampin. - Sedative hypnotics. - Sulfaphenazole. - Terfenadine. - Tranquilizers (unless allowed by investigator). - Tricyclic and tetracyclic antidepressants. - Troleandomycin. - Warfarin. Concurrent Treatment: Excluded: - Radiation therapy. Prior Medication: Excluded: - Cytolytic agents within 5 years prior to study entry. - Rifabutin and/or rifampin within 4 weeks prior to study entry. - Fluconazoles or other azoles within 4 weeks prior to study entry. - Glutathione, glutathione precursors, or related prodrugs within 2 weeks prior to study entry. Excluded within 72 hours prior to study entry: - Amiodarone. - Anesthetics, general. - Astemizole. - Azithromycin. - Cimetidine. - Ciprofloxacin. - Cisapride. - Clarithromycin. - Dexamethasone. - Disulfiram. - Erythromycin. - Fluoroquinolones. - Fluoxetine. - Hydrochlorothiazide. - Hypoglycemics, oral. - Isoniazid. - Levomepromazine. - Loratadine. - MAO inhibitors. - Methoxsalen. - Nafcillin. - Narcotic analgesics. - Naringenin. - Nifedipine. - Norethindrone. - Pentazocine. - Phenothiazines. - Phenytoin. - Protease inhibitors. - Quinidine. - Ranitidine. - Sedative hypnotics. - Sulfaphenazole. - Terfenadine. - Tranquilizers (unless allowed by investigator). - Troleandomycin. - Warfarin. Excluded within 4 weeks prior to study entry: - Barbiturates. - Carbamazepine. - Clotrimazole. - Gestodene. - Itraconazole. - Ketoconazole. - Miconazole. - Omeprazole. - Rifabutin. - Rifampin. - Tricyclic and tetracyclic antidepressants. Prior Treatment: Excluded: - Blood transfusion within 1 week prior to study entry. - Radiation therapy within 5 years prior to study entry. Active drug or alcohol abuse or dependence that would preclude completion of study.
Total Enrollment: 48
Location and Contact Information:
Overall Study Official:
UnadkatJ, Study Chair,
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Meharry Med College
Nashville, Tennessee, 37203
United States
Additional Information:
Study ID Numbers: ACTG 283;
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000826
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3. The Pharmacokinetics of Zidovudine and Oxazepam Alone and in Combination in the HIV-Infected Patient
4. Helping HIV Infected Patients in South Africa Adhere to Drug Regimens
5. Effectiveness of AZT and Nevirapine in Preventing HIV Transmission from Ugandan Mothers to Their Newborns
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Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites
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