A Study of Rifabutin, Used Alone or With Ethambutol in the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in Patients With AIDS
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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 4 |
| 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:
- AZT, d4T, ddI, or ddC.
- Antipneumocystis prophylaxis.
Allowed:
- Short course (< 14 days) of ciprofloxacin for acute infections.
Patients must have:
- AIDS.
- CD4 count <= 100 cells/mm3.
- NO prior or current MAC infection.
Prior Medication:
Required:
- Antipneumocystis prophylaxis for at least 4 weeks prior to study entry.
Allowed:
- Prior rifabutin.
- Prior ethambutol.
- Prior clarithromycin.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Positive tuberculin skin test (PPD > 5 mm).
- Active M. tuberculosis.
- Perceived as unreliable or unavailable for frequent monitoring.
Concurrent Medication:
Excluded:
- Other antiretrovirals not specifically allowed.
- All investigational drugs.
- Other antimycobacterial therapy, such as clarithromycin, azithromycin, rifampin, clofazimine, amikacin, streptomycin, isoniazid, cycloserine, ethionamide, and ciprofloxacin (>= 14 days).
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:
- Rifampin.
- Isoniazid.
- Clofazimine.
- Cycloserine.
- Ethionamide.
- Amikacin.
- Ciprofloxacin.
Contacts and Locations
More Information
No publications provided
| 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 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Rifabutin Mycobacterium avium-intracellulare Infection Drug Therapy, Combination Ethambutol Acquired Immunodeficiency Syndrome |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 16, 2013