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Sponsored by: |
Pharmacia |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002343 |
To optimize Mycobacterium avium Complex (MAC) prophylaxis in AIDS patients by measuring serum rifabutin levels and adjusting the dose accordingly. To combine rifabutin with ethambutol to examine the effect of combination therapy in preventing or delaying the incidence of MAC bacteremia in this patient population.
Condition | Intervention | Phase |
---|---|---|
Mycobacterium Avium-Intracellulare Infection HIV Infections |
Drug: Ethambutol hydrochloride Drug: Rifabutin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Pharmacodynamics Study |
Official Title: | An Open-Label Randomized Pharmacokinetic/Pharmacodynamic Study of Mycobutin (Rifabutin) or Rifabutin in Combination With Myambutol (Ethambutol) for Prophylaxis of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts <= 100 Cells/mm3 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
Patients must have:
Prior Medication:
Required:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Known hypersensitivity to rifabutin, rifampin, or other rifamycins and/or ethambutol.
Prior Medication:
Excluded within 4 weeks prior to study entry:
Study ID Numbers: | 048E, CS 087287-000 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002343 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Rifabutin Mycobacterium avium-intracellulare Infection Drug Therapy, Combination Ethambutol Acquired Immunodeficiency Syndrome |
Bacterial Infections Systemic Inflammatory Response Syndrome Sexually Transmitted Diseases, Viral Rifabutin Acquired Immunodeficiency Syndrome Bacteremia Mycobacterium Avium Complex Infection Mycobacterium Infections, Atypical Immunologic Deficiency Syndromes Inflammation Mycobacterium avium-intracellulare Infection |
Virus Diseases Anti-Bacterial Agents Gram-Positive Bacterial Infections Sepsis HIV Infections Sexually Transmitted Diseases Mycobacterium Infections Ethambutol Antitubercular Agents Retroviridae Infections |
Bacterial Infections Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Rifabutin Slow Virus Diseases Infection Anti-Bacterial Agents Gram-Positive Bacterial Infections Pathologic Processes Therapeutic Uses Retroviridae Infections Systemic Inflammatory Response Syndrome RNA Virus Infections Immune System Diseases |
Acquired Immunodeficiency Syndrome Bacteremia Pharmacologic Actions Immunologic Deficiency Syndromes Actinomycetales Infections Mycobacterium Infections, Atypical Antibiotics, Antitubercular Mycobacterium avium-intracellulare Infection Inflammation Virus Diseases Sepsis HIV Infections Sexually Transmitted Diseases Lentivirus Infections Mycobacterium Infections |