Document Detail

A randomized, double-blind trial comparing azithromycin and clarithromycin in the treatment of disseminated Mycobacterium avium infection in patients with human immunodeficiency virus.
MedLine Citation:
PMID:  11073759     Owner:  NLM     Status:  MEDLINE    
Two hundred and forty-six patients infected with human immunodeficiency virus (HIV) who also had disseminated Mycobacterium avium complex received either azithromycin 250 mg every day, azithromycin 600 mg every day, or clarithromycin 500 mg twice a day, each combined with ethambutol, for 24 weeks. Samples drawn from patients were cultured and clinically assessed every 3 weeks up to week 12, then monthly thereafter through week 24 of double-blind therapy and every 3 months while on open-label therapy through the conclusion of the trial. The azithromycin 250 mg arm of the study was dropped after an interim analysis showed a lower rate of clearance of bacteremia. At 24 weeks of therapy, the likelihood of patients' developing 2 consecutive negative cultures (46% vs. 56%, P=.24) or 1 negative culture (59% vs. 61%, P=.80) was similar for azithromycin 600 mg (n=68) and clarithromycin (n=57), respectively. The likelihood of relapse was 39% versus 27% (P=.21) on azithromycin compared with clarithromycin, respectively. Of the 6 patients who experienced relapse, none of those randomized to receive azithromycin developed isolates resistant to macrolides, compared with 2 of 3 patients randomized to receive clarithromycin [corrected]. Mortality was similar in patients comprising each arm of the study (69% vs. 63%; hazard, 95.1% confidence interval, 1.1 [0.7, 1.7]). Azithromycin 600 mg, when given in combination with ethambutol, is an effective agent for the treatment of disseminated M. avium disease in patients infected with HIV.
M Dunne; J Fessel; P Kumar; G Dickenson; P Keiser; M Boulos; M Mogyros; A C White Jr; P Cahn; M O'Connor; D Lewi; S Green; J Tilles; C Hicks; J Bissett; M M Schneider; R Benner
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2000-11-06
Journal Detail:
Title:  Clinical infectious diseases : an official publication of the Infectious Diseases Society of America     Volume:  31     ISSN:  1058-4838     ISO Abbreviation:  Clin. Infect. Dis.     Publication Date:  2000 Nov 
Date Detail:
Created Date:  2000-12-26     Completed Date:  2001-01-11     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9203213     Medline TA:  Clin Infect Dis     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1245-52     Citation Subset:  IM    
Pfizer Central Research, Groton, CT 06340, USA.
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MeSH Terms
AIDS-Related Opportunistic Infections / drug therapy*
Anti-Bacterial Agents / adverse effects,  therapeutic use*
Azithromycin / adverse effects,  therapeutic use*
Clarithromycin / adverse effects,  therapeutic use*
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Drug Therapy, Combination / therapeutic use
Ethambutol / therapeutic use
Gastrointestinal Diseases / chemically induced
Mycobacterium avium Complex / drug effects*
Mycobacterium avium-intracellulare Infection / drug therapy*
Survival Analysis
Treatment Outcome
Reg. No./Substance:
0/Anti-Bacterial Agents; 74-55-5/Ethambutol; 81103-11-9/Clarithromycin; 83905-01-5/Azithromycin
Erratum In:
Clin Infect Dis 2001 May 1;32(9):1386

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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