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

Abbott

Status: Completed

Conditions: Mycobacterium Avium-intracellular Infection; HIV Infections

Treatments: Drug: Clofazimine; Drug: Ethambutol hydrochloride; Drug: Clarithromycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002331

214A

M93-069

Details and patient eligibility

About

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.

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.