The Safety and Effectiveness of Clarithromycin in the Prevention of Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients
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
2 other identifiers
interventional
N/A
1 country
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 1992
Typical duration for not_applicable
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1992
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 1994
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 1994
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJanuary 16, 2015
February 1, 2009
2 years
November 2, 1999
January 15, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- HIV infection.
- CD4 count \<= 100 cells/mm3.
- No evidence of MAC.
- Life expectancy of at least 6 months.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (22)
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724, United States
California Med Research Group
Fresno, California, 93726, United States
HIV Research Group
San Diego, California, 92102, United States
Saint Francis Mem Hosp
San Francisco, California, 94109, United States
Kaiser Permanente Med Ctr
San Francisco, California, 94115, United States
Santa Clara Valley Med Ctr
San Jose, California, 951282699, 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
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
New York Med College / Westchester County Med Ctr
Valhalla, New York, 10595, United States
Nalle Clinic
Charlotte, North Carolina, 28207, United States
Westover Heights Clinic
Portland, Oregon, 97210, United States
Univ of Tennessee
Memphis, Tennessee, 38163, United States
Vanderbilt Univ
Nashville, Tennessee, 37212, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235, United States
Houston Veterans Administration Med Ctr
Houston, Texas, 77030, 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 (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. doi: 10.1056/NEJM199608083350603.
PMID: 8663871BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Start
November 1, 1992
Primary Completion
November 1, 1994
Study Completion
November 1, 1994
Last Updated
January 16, 2015
Record last verified: 2009-02