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| Sponsor: | Pharmacia |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002343 |
Purpose
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: | Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| 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 |
Eligibility| 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:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00002343 History of Changes |
| Other Study ID Numbers: | 048E, CS 087287-000 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Rifabutin Mycobacterium avium-intracellulare Infection Drug Therapy, Combination Ethambutol Acquired Immunodeficiency Syndrome |
|
HIV Infections Acquired Immunodeficiency Syndrome Bacteremia Mycobacterium Infections Mycobacterium avium-intracellulare Infection Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Bacterial Infections |
Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Actinomycetales Infections Gram-Positive Bacterial Infections Mycobacterium Infections, Atypical Ethambutol Rifabutin Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |