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

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:

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.

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

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