Search / Trial NCT00000826

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

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Trial Information

Current as of November 28, 2023

Completed

Keywords

Rifabutin Trimethoprim Sulfamethoxazole Combination Aids Related Opportunistic Infections Dapsone Drug Interactions Fluconazole Acquired Immunodeficiency Syndrome Aids Related Complex Clarithromycin Sulfamethoxazole Trimethoprim

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. 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.

Attachments

readout_NCT00000826_2023-11-28.pdf

4.5 MB

NCT00000826_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

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

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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