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Trial record 89 of 398 for:    CLARITHROMYCIN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002336
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : January 16, 2015
Information provided by:

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

Condition or disease Intervention/treatment Phase
Mycobacterium Avium-intracellular Infection HIV Infections Drug: Clarithromycin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Masking: Double
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study of the Safety and Efficacy of Clarithromycin for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients With CD4 Counts <= 100 Cells/mm3
Study Start Date : November 1992
Actual Primary Completion Date : November 1994
Actual Study Completion Date : November 1994

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002336

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United States, Arizona
Univ of Arizona / Health Science Ctr
Tucson, Arizona, United States, 85724
United States, California
California Med Research Group
Fresno, California, United States, 93726
HIV Research Group
San Diego, California, United States, 92102
Saint Francis Mem Hosp
San Francisco, California, United States, 94109
Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115
Santa Clara Valley Med Ctr
San Jose, California, United States, 951282699
United States, Florida
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, United States, 33308
Dr Nelson Zide
Hollywood, Florida, United States, 33021
Infectious Disease Research Institute Inc
Tampa, Florida, United States, 33614
United States, Indiana
Indiana Univ Hosp
Indianapolis, Indiana, United States, 46202
United States, New York
Saint Vincent's Hosp and Med Ctr
New York, New York, United States, 10011
SUNY / Health Sciences Ctr at Syracuse
Syracuse, New York, United States, 13210
New York Med College / Westchester County Med Ctr
Valhalla, New York, United States, 10595
United States, North Carolina
Nalle Clinic
Charlotte, North Carolina, United States, 28207
United States, Oregon
Westover Heights Clinic
Portland, Oregon, United States, 97210
United States, Tennessee
Univ of Tennessee
Memphis, Tennessee, United States, 38163
Vanderbilt Univ
Nashville, Tennessee, United States, 37212
United States, Texas
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States, 75235
Houston Veterans Administration Med Ctr
Houston, Texas, United States, 77030
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, United States, 78284
United States, Virginia
Salem Veterans Administration Med Ctr
Salem, Virginia, United States, 24153
United States, Washington
Dr Alan D Tice / Infections Ltd
Tacoma, Washington, United States, 98405
Sponsors and Collaborators

Layout table for additonal information Identifier: NCT00002336     History of Changes
Other Study ID Numbers: 124A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: January 16, 2015
Last Verified: February 2009
Keywords provided by Abbott:
Mycobacterium avium-intracellular Infection
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
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Communicable Diseases
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Nontuberculous
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors