Expired Study
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San Jose, California 95128


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.


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.


Study is Available At:


Original ID:

124A


NCT ID:

NCT00002336


Secondary ID:

M91-561


Study Acronym:


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 C


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

12 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Abbott


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Masking: Do


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Start Date:November 1992
Completion Date:November 1994
Completion Type:Actual
Primary Completion Date:November 1994
Primary Completion Type:Actual
Verification Date:February 2009
Last Changed Date:January 15, 2015
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Clarithromycin

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Abbott

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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.
PMID:8663871

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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