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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00002336
First received: November 2, 1999
Last updated: February 19, 2009
Last verified: February 2009
  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-intracellular Infection
HIV Infections
Drug: Clarithromycin

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Abbott:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Abbott
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002336     History of Changes
Other Study ID Numbers: 124A, M91-561
Study First Received: November 2, 1999
Last Updated: February 19, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Mycobacterium avium-intracellular Infection
Acquired Immunodeficiency Syndrome
Clarithromycin

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Nontuberculous
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2014