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NCT00002336 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002336
Other study ID # 124A
Secondary ID M91-561
Status Completed
Phase N/A
First received November 2, 1999
Last updated January 15, 2015
Start date November 1992
Est. completion date November 1994

Study information
Verified date February 2009
Source Abbott
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date November 1994
Est. primary completion date November 1994
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Clarithromycin

Locations
Country Name City State
United States Nalle Clinic Charlotte North Carolina
United States Univ of Texas Southwestern Med Ctr of Dallas Dallas Texas
United States TheraFirst Med Ctrs Inc Fort Lauderdale Florida
United States California Med Research Group Fresno California
United States Dr Nelson Zide Hollywood Florida
United States Houston Veterans Administration Med Ctr Houston Texas
United States Indiana Univ Hosp Indianapolis Indiana
United States Univ of Tennessee Memphis Tennessee
United States Vanderbilt Univ Nashville Tennessee
United States Saint Vincent's Hosp and Med Ctr New York New York
United States Westover Heights Clinic Portland Oregon
United States Salem Veterans Administration Med Ctr Salem Virginia
United States Audie L Murphy Veterans Administration Hosp San Antonio Texas
United States HIV Research Group San Diego California
United States Kaiser Permanente Med Ctr San Francisco California
United States Saint Francis Mem Hosp San Francisco California
United States Santa Clara Valley Med Ctr San Jose California
United States SUNY / Health Sciences Ctr at Syracuse Syracuse New York
United States Dr Alan D Tice / Infections Ltd Tacoma Washington
United States Infectious Disease Research Institute Inc Tampa Florida
United States Univ of Arizona / Health Science Ctr Tucson Arizona
United States New York Med College / Westchester County Med Ctr Valhalla New York

Sponsors (1)
Lead Sponsor Collaborator
Abbott

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

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