A Study of Rifabutin, Used Alone or With Ethambutol in the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in Patients With AIDS

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Mycobacterium Avium-Intracellulare Infection, HIV Infections

Intervention / Treatment
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* Drug: Ethambutol hydrochloride
* Drug: Rifabutin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ethambutol hydrochloride|nan|
|Drug: Rifabutin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rifabutin, Mycobacterium avium-intracellulare Infection, Drug Therapy, Combination, Ethambutol, Acquired Immunodeficiency Syndrome