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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001058 |
Purpose
To compare the efficacy and safety of clarithromycin combined with rifabutin, ethambutol, or both in the treatment of disseminated Mycobacterium avium Complex (MAC) disease in persons with AIDS, including individuals who have or have not received prior MAC prophylaxis.
It is believed that effective therapy for MAC disease in patients with AIDS requires combinations of two or more antimycobacterial agents in order to overcome drug resistance and the unfavorable influence of the profound immunosuppression associated with AIDS. Data suggest that clarithromycin may have substantial activity in two- or three-drug combination regimens with clofazimine, rifamycin derivatives, ethambutol, or the 4-quinolones.
| Condition | Intervention | Phase |
|
Mycobacterium Avium-Intracellulare Infection HIV Infections |
Drug: Indinavir sulfate Drug: Ritonavir Drug: Ethambutol hydrochloride Drug: Clarithromycin Drug: Rifabutin |
Phase II |
| MedlinePlus related topics: | AIDS |
| ChemIDplus related topics: | Indinavir Indinavir Sulfate Rifabutin Ritonavir Ethambutol hydrochloride Ethambutol Clarithromycin Ciprofloxacin Ciprofloxacin hydrochloride Clofazimine |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | A Phase II/III Prospective, Multicenter, Randomized, Controlled Trial Comparing the Safety and Efficacy of Three Clarithromycin-Containing Combination Drug Regimens for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Disease in Persons With AIDS |
| Estimated Enrollment: | 246 |
It is believed that effective therapy for MAC disease in patients with AIDS requires combinations of two or more antimycobacterial agents in order to overcome drug resistance and the unfavorable influence of the profound immunosuppression associated with AIDS. Data suggest that clarithromycin may have substantial activity in two- or three-drug combination regimens with clofazimine, rifamycin derivatives, ethambutol, or the 4-quinolones.
Patients are randomized to one of three treatment arms containing clarithromycin in combination with ethambutol, rifabutin, or both. Clarithromycin alone is taken on days 1 through 3 to determine tolerance and rifabutin and/or ethambutol is added on day 3. AS PER AMENDMENT 7/2/97: Patients may elect to add ritonavir or indinavir to their treatment regimen. Treatment continues daily for 48 weeks. In the absence of a dose-limiting toxicity, those patients who are determined to be complete or partial responders continue on the regimen to which they were originally assigned. Patients who have failed or relapsed on originally assigned MAC therapy, must have their therapy amended to receive clarithromycin and at least two other drugs not included in their originally assigned regimen. Patients are followed twice in the first week, then every 2 weeks for the first 2 months, then monthly for the next 4 months, and then every 2 months thereafter until the end of 12 months. PER AMENDMENT 10/10/96: NOTE: Any patient who develops a toxicity to rifabutin or ethambutol after week 12 or thereafter will be offered the option of being registered to a salvage regimen of 2 new drugs not previously received, plus clarithromycin to continue for the study duration.
Eligibility
| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
PER AMENDMENT 10/10/96:
PER AMENDMENT 7/02/97:
Patients must have:
NOTE:
Prior Medication:
Allowed:
PER AMENDMENT 10/10/96:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
PER AMENDMENT 7/2/97:
Patients with the following prior condition are excluded:
Prior Medication:
Excluded:
NOTE:
PER AMENDMENT 10/10/96:
Contacts and Locations![]() |
Show 49 Study Locations |
| Study Chair: | Benson CA | |
| Study Chair: | Chaisson RE | |
| Study Chair: | Currier JS |
More Information
| Flexner C, Noe D, Benson C, Currier J, Andrade A, Shaver A. Adherence patterns in patients with symptomatic Mycobacterium avium complex (MAC) infection taking a twice-daily clarithromycin regimen. ACTG 223 Study Team. Int Conf AIDS. 1998;12:585 (abstract no 32324) |
|
Benson CA, Williams PL, Currier JS, Holland F, Mahon LF, MacGregor RR, Inderlied CB, Flexner C, Neidig J, Chaisson R, Notario GF, Hafner R; AIDS Clinical Trials Group 223 Protocol Team. A prospective, randomized trial examining the efficacy and safety of clarithromycin in combination with ethambutol, rifabutin, or both for the treatment of disseminated Mycobacterium avium complex disease in persons with acquired immunodeficiency syndrome. Clin Infect Dis. 2003 Nov 1;37(9):1234-43. Epub 2003 Oct 03.
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| Study ID Numbers: | ACTG 223 |
| First Received: | November 2, 1999 |
| Last Updated: | July 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001058 |
| Health Authority: | United States: Federal Government |
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