Status:
COMPLETED
Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Bacterial Infections
Mycoses
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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-infecte...
Detailed Description
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...
Eligibility 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
May 1 1999
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00000826
End Date
May 1 1999
Last Update
October 29 2021
Active Locations (2)
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1
Ucsf Aids Crs
San Francisco, California, United States
2
University of Washington AIDS CRS
Seattle, Washington, United States, 98122