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

NCT00002140

Last updated date
Study Location
East Bay AIDS Ctr
Berkeley, California, 94705, United States
Contact
1-800-718-1021

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1-800-718-1021

By email

Contact

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Mycobacterium Avium-intracellulare Infection, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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).

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief 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..
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Mycobacterium Avium-intracellulare Infection
  • HIV Infections
Intervention  ICMJE
  • Drug: Ethambutol hydrochloride
  • Drug: Clarithromycin
  • Drug: Azithromycin
Study Arms  ICMJE Not Provided
Publications * Dunne M, Fessel J, Kumar P, Dickenson G, Keiser P, Boulos M, Mogyros M, White AC Jr, 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002140
Other Study ID Numbers  ICMJE 226B
066-189
189/189B
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account NIH AIDS Clinical Trials Information Service
Verification Date July 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP