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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002331

Enrollment

Unknown

Registered

2001-08-31

Start date

1994-01-31

Completion date

1995-03-31

Last updated

2015-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mycobacterium Avium-intracellular Infection, HIV Infections

Keywords

Mycobacterium avium-intracellular Infection, Drug Therapy, Combination, Ethambutol, Clofazimine, Acquired Immunodeficiency Syndrome, Clarithromycin

Brief summary

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.

Interventions

DRUGEthambutol hydrochloride

DRUGClarithromycin

DRUGClofazimine

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

Healthy volunteers

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.

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026