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

This study has been completed.

Sponsored by: Abbott
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002336
  Purpose

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 Intervention
Mycobacterium Avium-Intracellulare Infection
HIV Infections
Drug: Clarithromycin

MedlinePlus related topics:   AIDS   

Drug Information available for:   Clarithromycin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind, Safety Study
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
  Eligibility
Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002336

Locations
United States, Arizona
Univ of Arizona / Health Science Ctr    
      Tucson, Arizona, United States, 85724
United States, California
HIV Research Group    
      San Diego, California, United States, 92102
Saint Francis Mem Hosp    
      San Francisco, California, United States, 94109
Santa Clara Valley Med Ctr    
      San Jose, California, United States, 951282699
California Med Research Group    
      Fresno, California, United States, 93726
Kaiser Permanente Med Ctr    
      San Francisco, California, United States, 94115
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
New York Med College / Westchester County Med Ctr    
      Valhalla, New York, United States, 10595
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
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
Vanderbilt Univ    
      Nashville, Tennessee, United States, 37212
Univ of Tennessee    
      Memphis, Tennessee, United States, 38163
United States, Texas
Houston Veterans Administration Med Ctr    
      Houston, Texas, United States, 77030
Univ of Texas Southwestern Med Ctr of Dallas    
      Dallas, Texas, United States, 75235
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
Abbott
  More Information


Publications:

Study ID Numbers:   124A, M91-561
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002336
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Mycobacterium avium-intracellulare Infection  
Acquired Immunodeficiency Syndrome  
Clarithromycin  

Study placed in the following topic categories:
Bacterial Infections
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Mycobacterium Infections, Atypical
Mycobacterium avium-intracellulare Infection
Virus Diseases
Clarithromycin
Gram-Positive Bacterial Infections
HIV Infections
Sexually Transmitted Diseases
Mycobacterium Infections
Mycobacterium avium complex infection
Retroviridae Infections

Additional relevant MeSH terms:
Communicable Diseases
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Actinomycetales Infections
Pharmacologic Actions
Protein Synthesis Inhibitors
Anti-Bacterial Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on December 03, 2008




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