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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000826 |
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.
Condition | Intervention | Phase |
---|---|---|
Bacterial Infections Mycoses HIV Infections |
Drug: Clarithromycin Drug: Rifabutin Drug: Sulfamethoxazole-Trimethoprim Drug: Dapsone Drug: Fluconazole |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Pharmacokinetics Study |
Official Title: | Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole and Dapsone and Their Hydroxylamine Metabolites |
Estimated Enrollment: | 48 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Prior Medication:
Excluded:
Excluded within 72 hours prior to study entry:
Excluded within 4 weeks prior to study entry:
Prior Treatment:
Excluded:
Active drug or alcohol abuse or dependence that would preclude completion of study.
United States, California | |
San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 | |
United States, District of Columbia | |
Georgetown Univ Med Ctr | |
Washington, District of Columbia, United States, 20007 | |
United States, Tennessee | |
Meharry Med College | |
Nashville, Tennessee, United States, 37203 | |
United States, Washington | |
Univ of Washington | |
Seattle, Washington, United States, 981224304 |
Study Chair: | Unadkat J | |
Study Chair: | Trapnell CB |
Study ID Numbers: | ACTG 283 |
Study First Received: | November 2, 1999 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00000826 |
Health Authority: | United States: Federal Government |
Rifabutin Trimethoprim-Sulfamethoxazole Combination AIDS-Related Opportunistic Infections Dapsone Drug Interactions |
Fluconazole Acquired Immunodeficiency Syndrome AIDS-Related Complex Clarithromycin Sulfamethoxazole-Trimethoprim |
Fluconazole Bacterial Infections Opportunistic Infections Trimethoprim Sexually Transmitted Diseases, Viral Rifabutin Sulfamethoxazole Clotrimazole Miconazole Acquired Immunodeficiency Syndrome Tioconazole Trimethoprim-Sulfamethoxazole Combination |
AIDS-Related Complex Immunologic Deficiency Syndromes Folic Acid Virus Diseases Clarithromycin Mycoses HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Dapsone Retroviridae Infections |
Communicable Diseases Anti-Infective Agents RNA Virus Infections Antiprotozoal Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Anti-Infective Agents, Urinary Enzyme Inhibitors Renal Agents Infection Folic Acid Antagonists |
Pharmacologic Actions Antibiotics, Antitubercular Protein Synthesis Inhibitors Anti-Bacterial Agents Antimalarials Antiparasitic Agents Antifungal Agents Therapeutic Uses Lentivirus Infections Antitubercular Agents Leprostatic Agents |