Expired Study
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Oakland, California 94609


Purpose:

To evaluate the efficacy and safety of two different doses of azithromycin in combination with ethambutol for the treatment of patients with Mycobacterium avium complex (MAC) infection, and to determine whether an azithromycin-containing regimen is at least as safe and effective as the same regimen containing clarithromycin..


Study summary:

Patients are randomized to receive azithromycin at one of two doses in combination with ethambutol or clarithromycin in combination with ethambutol for 24 weeks, after which they are evaluated for entry into a maintenance phase of treatment. Clinical, microbiologic, and safety assessments are performed every 3 weeks for the first 12 weeks, then monthly for the remaining 12 weeks.


Criteria:

Inclusion Criteria Patients must have: - HIV seropositivity. - Disseminated MAC. - No MAC therapy between time of last positive blood culture draw and study entry (single-agent prophylaxis allowed). - Life expectancy of at least 2 months. - Consent of parent or guardian if below legal age of consent. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Known hypersensitivity to macrolide antibiotics (erythromycin, azithromycin, or clarithromycin) or ethambutol. - Inability to take oral medications. - Condition likely to interfere with drug absorption (e.g., gastrectomy, malabsorption syndromes). Concurrent Medication: Excluded: - Another investigational drug started in the week prior to study entry. Prior Medication: Excluded: - MAC therapy between time of last positive blood culture draw and study entry (although single-agent prophylaxis is allowed).


Study is Available At:


Original ID:

226B


NCT ID:

NCT00002140


Secondary ID:

066-189


Study Acronym:


Brief Title:

A Randomized, Double-Blind, Comparative Study of Azithromycin Versus Clarithromycin in Combination With Ethambutol for the Treatment of Disseminated M


Official Title:

A Randomized, Double-Blind, Comparative Study of Azithromycin Versus Clarithromycin in Combination With Ethambutol for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Infection in AIDs Patients


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

13 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Masking:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Verification Date:July 1998
Last Changed Date:June 23, 2005
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Ethambutol hydrochloride
Intervention Type:Drug
Name:Clarithromycin
Intervention Type:Drug
Name:Azithromycin

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Dunne M, Fessel J, Kumar P, Dickenson G, Keiser P, Boulos M, Mogyros M, White Jr AC, Cahn P, O'Connor M, Lewi D, Green S, Tilles J, Hicks C, Bissett J, Schneider MM, Benner R. A randomized, double-blind trial comparing azithromycin and clarithromycin in the treatment of disseminated Mycobacterium avium infection in patients with human immunodeficiency virus. Clin Infect Dis. 2000 Nov;31(5):1245-52. Epub 2000 Nov 6. Erratum in: Clin Infect Dis 2001 May 1;32(9):1386.
PMID:11073759

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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