The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS

Study Overview
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Brief Summary
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PRIMARY: To assess the tolerability of the combination regimen of clarithromycin plus ethambutol with or without clofazimine in patients with disseminated Mycobacterium avium Complex (dMAC). SECONDARY: To determine the proportion of patients achieving a sterile blood culture along with the time required to achieve it. To determine the duration of bacteriological response, defined as length of time that blood cultures remain sterile.

Official Title
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A Randomized Open-Label Study of the Tolerability and Efficacy of Clarithromycin and Ethambutol in Combination With or Without Clofazimine for the Treatment of Disseminated MAC (dMAC) in Patients With AIDS

Conditions
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Mycobacterium Avium-intracellular Infection, HIV Infections

Intervention / Treatment
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* Drug: Ethambutol hydrochloride
* Drug: Clarithromycin
* Drug: Clofazimine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients must have: History of HIV seropositivity. Disseminated MAC. Positive blood culture for MAC within 4 weeks prior to study entry. Consent of parent or guardian if less than 18 years of age. Ability to complete the study. NOTE: Patients with active opportunistic infections other than dMAC are permitted if dosage and clinical parameters have been stable for 4 weeks prior to enrollment. Exclusion Criteria Concurrent Medication: Excluded: Active therapy with carbamazepine or theophylline, unless investigator agrees to carefully monitor blood levels. Active therapy with investigational drugs other than treatment for HIV disease, except with approval of the sponsor. Concomitant terfenadine (Seldane or Seldane-D) or astemizole (Hismanal). Amikacin. Azithromycin. Capreomycin. Ciprofloxacin. Cycloserine. Ethionamide. Gentamicin. Kanamycin. Levofloxacin. Lomefloxacin. Ofloxacin. Rifampin. Rifabutin. Sparfloxacin. Streptomycin. Any other aminoglycosides, quinolones, and macrolides. Patients with the following prior conditions are excluded: History of allergy or hypersensitivity to macrolides, ethambutol, or clofazimine. Prior Medication: Excluded: Other antimycobacterials, including aminoglycosides, ansamycin (rifabutin), other macrolides (such as clindamycin), quinolones, and rifampin, between screening and study entry. Clarithromycin or azithromycin as prophylaxis or treatment (for any cause) for more than 14 days cumulative within the past 2 months.

Ages Eligible for Study
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Minimum Age: 13 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ethambutol hydrochloride|nan|
|Drug: Clarithromycin|nan|
|Drug: Clofazimine|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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Mycobacterium avium-intracellular Infection, Drug Therapy, Combination, Ethambutol, Clofazimine, Acquired Immunodeficiency Syndrome, Clarithromycin