Mycobacterium Avium Complex/mac |
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Clinical Trial: A Study of Rifabutin, Used Alone or with Ethambutol in the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in Patients with AIDS
This study has been completed.
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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 | Treatment or Intervention | Phase |
|---|---|---|
| Mycobacterium avium-intracellulare Infection HIV Infections | Drug: Ethambutol hydrochloride Drug: Rifabutin | Phase IV |
MedlinePlus related topics: AIDS; Bacterial Infections
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
Expected Total Enrollment: 200
Patients are randomized to receive oral rifabutin alone or rifabutin/ethambutol daily for 12 months, with possible continuation of medicine lifelong. Doses will be adjusted to maintain minimum blood levels of the drugs.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
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.
Location Information
California
Univ of California - Davis Med Ctr / CARES, Sacramento, California, 95817, United States
More Information
Record last reviewed: June 1997
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00002343
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Simple Facts Sheets: MAC (AIDS Treatment Data Network)

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