The Safety and Effectiveness of Clarithromycin in the Prevention of Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients

NCT ID: NCT00002336

Last Updated: 2015-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

1992-11-30

Study Completion Date

1994-11-30

Brief Summary

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To determine whether clarithromycin is safe and effective in preventing disseminated Mycobacterium avium Complex in HIV-infected patients with CD4 counts \<= 100 cells/mm3.

Detailed Description

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Conditions

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Mycobacterium Avium-intracellular Infection HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Clarithromycin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients must have:

* HIV infection.
* CD4 count \<= 100 cells/mm3.
* No evidence of MAC.
* Life expectancy of at least 6 months.

Exclusion Criteria

Concurrent Medication:

Excluded:

* Certain restricted drugs (details not available).

Patients with the following prior conditions are excluded:

History of allergy or hypersensitivity to macrolides. Active substance abuse or other conditions that would affect study compliance.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Locations

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Univ of Arizona / Health Science Ctr

Tucson, Arizona, United States

Site Status

California Med Research Group

Fresno, California, United States

Site Status

HIV Research Group

San Diego, California, United States

Site Status

Saint Francis Mem Hosp

San Francisco, California, United States

Site Status

Kaiser Permanente Med Ctr

San Francisco, California, United States

Site Status

Santa Clara Valley Med Ctr

San Jose, California, United States

Site Status

TheraFirst Med Ctrs Inc

Fort Lauderdale, Florida, United States

Site Status

Dr Nelson Zide

Hollywood, Florida, United States

Site Status

Infectious Disease Research Institute Inc

Tampa, Florida, United States

Site Status

Indiana Univ Hosp

Indianapolis, Indiana, United States

Site Status

Saint Vincent's Hosp and Med Ctr

New York, New York, United States

Site Status

SUNY / Health Sciences Ctr at Syracuse

Syracuse, New York, United States

Site Status

New York Med College / Westchester County Med Ctr

Valhalla, New York, United States

Site Status

Nalle Clinic

Charlotte, North Carolina, United States

Site Status

Westover Heights Clinic

Portland, Oregon, United States

Site Status

Univ of Tennessee

Memphis, Tennessee, United States

Site Status

Vanderbilt Univ

Nashville, Tennessee, United States

Site Status

Univ of Texas Southwestern Med Ctr of Dallas

Dallas, Texas, United States

Site Status

Houston Veterans Administration Med Ctr

Houston, Texas, United States

Site Status

Audie L Murphy Veterans Administration Hosp

San Antonio, Texas, United States

Site Status

Salem Veterans Administration Med Ctr

Salem, Virginia, United States

Site Status

Dr Alan D Tice / Infections Ltd

Tacoma, Washington, United States

Site Status

Countries

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United States

References

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Pierce M, Crampton S, Henry D, Heifets L, LaMarca A, Montecalvo M, Wormser GP, Jablonowski H, Jemsek J, Cynamon M, Yangco BG, Notario G, Craft JC. A randomized trial of clarithromycin as prophylaxis against disseminated Mycobacterium avium complex infection in patients with advanced acquired immunodeficiency syndrome. N Engl J Med. 1996 Aug 8;335(6):384-91. doi: 10.1056/NEJM199608083350603.

Reference Type BACKGROUND
PMID: 8663871 (View on PubMed)

Other Identifiers

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M91-561

Identifier Type: -

Identifier Source: secondary_id

124A

Identifier Type: -

Identifier Source: org_study_id

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