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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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mycobacterium Avium-intracellulare Infection; HIV Infections

Intervention: Ethambutol hydrochloride (Drug); Clarithromycin (Drug); Azithromycin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Summary

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..

Clinical Details

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

Study design: Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Detailed description: 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.

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

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).

Locations and Contacts

East Bay AIDS Ctr, Berkeley, California 94705, United States

Dr Milton Estes, Mill Valley, California 94941, United States

Infectious Disease Med Group / Adult Immunology Clinic, Oakland, California 94609, United States

UCI Med Ctr, Orange, California 92668, United States

Kaiser Permanente Med Ctr, San Francisco, California 94115, United States

Santa Clara Valley Med Ctr, San Jose, California 951282699, United States

Pfizer Central Research, Groton, Connecticut 06340, United States

Georgetown Univ Med Ctr, Washington, District of Columbia 20007, United States

Whitman - Walker Clinic, Washington, District of Columbia 20009, United States

Med Service, Miami, Florida 33125, United States

Dr Robert Wallace, St Petersburg, Florida 33713, United States

Bay Area AIDS Consortium, Tampa, Florida 33609, United States

West Paces Clinical Research Inc, Atlanta, Georgia 30327, United States

Dr Neel French / Louis A Weiss Memorial Hosp, Chicago, Illinois 60640, United States

Northwestern Univ Med School, Chicago, Illinois 60611, United States

Oschner Clinic, New Orleans, Louisiana 70121, United States

Trinity Lutheran Hosp / Infectious Disease Clinic, Kansas City, Missouri 64108, United States

Duke Univ Med Ctr, Durham, North Carolina 27710, United States

Austin Infectious Disease Consultants, Austin, Texas 78705, United States

Central Texas Med Foundation, Austin, Texas 78751, United States

Univ of Texas Southwestern Med Ctr of Dallas, Dallas, Texas 75235, United States

Dr Gary Brewton, Houston, Texas 77027, United States

Thomas Street Clinic / Baylor College of Medicine, Houston, Texas 77009, United States

Hampton Roads Med Specialists, Hampton, Virginia 23666, United States

Additional Information

Related publications:

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.


Last updated: June 23, 2005

Page last updated: August 23, 2015

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