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

Condition(s) targeted: Mycobacterium Avium-Intracellulare Infection; HIV Infections

Intervention: Clarithromycin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Abbott

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

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 design: Treatment, Double-Blind, Safety Study

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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.

Univ of Arizona / Health Science Ctr, Tucson, Arizona 85724, United States

HIV Research Group, San Diego, California 92102, United States

Saint Francis Mem Hosp, San Francisco, California 94109, United States

Santa Clara Valley Med Ctr, San Jose, California 951282699, United States

California Med Research Group, Fresno, California 93726, United States

Kaiser Permanente Med Ctr, San Francisco, California 94115, United States

TheraFirst Med Ctrs Inc, Fort Lauderdale, Florida 33308, United States

Dr Nelson Zide, Hollywood, Florida 33021, United States

Infectious Disease Research Institute Inc, Tampa, Florida 33614, United States

Indiana Univ Hosp, Indianapolis, Indiana 46202, United States

New York Med College / Westchester County Med Ctr, Valhalla, New York 10595, United States

Saint Vincent's Hosp and Med Ctr, New York, New York 10011, United States

SUNY / Health Sciences Ctr at Syracuse, Syracuse, New York 13210, United States

Nalle Clinic, Charlotte, North Carolina 28207, United States

Westover Heights Clinic, Portland, Oregon 97210, United States

Vanderbilt Univ, Nashville, Tennessee 37212, United States

Univ of Tennessee, Memphis, Tennessee 38163, United States

Houston Veterans Administration Med Ctr, Houston, Texas 77030, United States

Univ of Texas Southwestern Med Ctr of Dallas, Dallas, Texas 75235, United States

Audie L Murphy Veterans Administration Hosp, San Antonio, Texas 78284, United States

Salem Veterans Administration Med Ctr, Salem, Virginia 24153, United States

Dr Alan D Tice / Infections Ltd, Tacoma, Washington 98405, United States

Related 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.

Last updated: June 23, 2005