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

Primary Purpose

Mycobacterium Avium-intracellular Infection, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clarithromycin
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mycobacterium Avium-intracellular Infection focused on measuring Mycobacterium avium-intracellular Infection, Acquired Immunodeficiency Syndrome, Clarithromycin

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Arizona / Health Science Ctr
  • California Med Research Group
  • HIV Research Group
  • Saint Francis Mem Hosp
  • Kaiser Permanente Med Ctr
  • Santa Clara Valley Med Ctr
  • TheraFirst Med Ctrs Inc
  • Dr Nelson Zide
  • Infectious Disease Research Institute Inc
  • Indiana Univ Hosp
  • Saint Vincent's Hosp and Med Ctr
  • SUNY / Health Sciences Ctr at Syracuse
  • New York Med College / Westchester County Med Ctr
  • Nalle Clinic
  • Westover Heights Clinic
  • Univ of Tennessee
  • Vanderbilt Univ
  • Univ of Texas Southwestern Med Ctr of Dallas
  • Houston Veterans Administration Med Ctr
  • Audie L Murphy Veterans Administration Hosp
  • Salem Veterans Administration Med Ctr
  • Dr Alan D Tice / Infections Ltd

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
January 15, 2015
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00002336
Brief Title
The Safety and Effectiveness of Clarithromycin in the Prevention of Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients
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 Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
November 1992 (undefined)
Primary Completion Date
November 1994 (Actual)
Study Completion Date
November 1994 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycobacterium Avium-intracellular Infection, HIV Infections
Keywords
Mycobacterium avium-intracellular Infection, Acquired Immunodeficiency Syndrome, Clarithromycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Clarithromycin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Univ of Arizona / Health Science Ctr
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
California Med Research Group
City
Fresno
State/Province
California
ZIP/Postal Code
93726
Country
United States
Facility Name
HIV Research Group
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Saint Francis Mem Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Kaiser Permanente Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Santa Clara Valley Med Ctr
City
San Jose
State/Province
California
ZIP/Postal Code
951282699
Country
United States
Facility Name
TheraFirst Med Ctrs Inc
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Dr Nelson Zide
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Infectious Disease Research Institute Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Saint Vincent's Hosp and Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
New York Med College / Westchester County Med Ctr
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Nalle Clinic
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Westover Heights Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Univ of Tennessee
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Vanderbilt Univ
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Univ of Texas Southwestern Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Houston Veterans Administration Med Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Audie L Murphy Veterans Administration Hosp
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Salem Veterans Administration Med Ctr
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Dr Alan D Tice / Infections Ltd
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8663871
Citation
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.
Results Reference
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The Safety and Effectiveness of Clarithromycin in the Prevention of Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients

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