Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of January 15, 2025
Completed
Keywords
ClinConnect Summary
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 sam...
Gender
ALL
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.
Trial Officials
Unadkat J
Study Chair
Trapnell CB
Study Chair
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
San Francisco, California, United States
Seattle, Washington, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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