Once Weekly Azithromycin Therapy for Prevention of Mycobacterium avium Complex Infection in Patients with AIDS: A Randomized, Double-Blind, Placebo-Controlled Multicenter Trial

Edward C Oldfield; W. Jeffrey Fessel; Michael W Dunne; Gordon Dickinson; Mark R Wallace; William Byrne; Raymond Chung; Kenneth F Wagner; Scott F Paparello; Daniel B Craig; Gregory Melcher; Margan Zajdowicz; Richard F Williams; J. William Kelly; Michael Zelasky; Leonid B Heifets; Jonathan D Berman

doi:10.1086/514566

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Once Weekly Azithromycin Therapy for Prevention of Mycobacterium avium Complex Infection in Patients with AIDS: A Randomized, Double-Blind, Placebo-Controlled Multicenter Trial

Journal article

Open access

Peer reviewed

Once Weekly Azithromycin Therapy for Prevention of Mycobacterium avium Complex Infection in Patients with AIDS: A Randomized, Double-Blind, Placebo-Controlled Multicenter Trial

Edward C Oldfield, W. Jeffrey Fessel, Michael W Dunne, Gordon Dickinson, Mark R Wallace, William Byrne, Raymond Chung, Kenneth F Wagner, Scott F Paparello, Daniel B Craig, …

Clinical infectious diseases, Vol.26(3), pp.611-619

1998-03

DOI: https://doi.org/10.1086/514566

PMID: 9524832

Abstract

We conducted a randomized, double-blind, placebo-controlled multicenter trial of azithromycin (1,200 mg once weekly) for the prevention of Mycobacterium avium complex (MAC) infection in patients with AIDS and a CD4 cell count of <100/mm3. In an intent-to-treat analysis through the end of therapy plus 30 days, nine (10.6%) of 85 azithromycin recipients and 22 (24.7%) of 89 placebo recipients developed MAC infection (hazard ratio, 0.34; P = .004). There was no difference in the ranges of minimal inhibitory concentrations of either clarithromycin or azithromycin for the five breakthrough (first) MAC isolates from the azithromycin group and the 18 breakthrough MAC isolates from the placebo group. Of the 76 patients who died during the study, four (10.5%) of 38 azithromycin recipients and 12 (31.6%) of 38 placebo recipients had a MAC infection followed by death (P = .025). For deaths due to all causes, there was no difference in time to death or number of deaths between the two groups. Episodes of non-MAC bacterial infection per 100 patient years occurred in 43 azithromycin recipients and 88 placebo recipients (relative risk, 0.49; 95% confidence interval, 0.33–0.73). The most common toxic effect noted during the study was gastrointestinal, reported by 78.9% of azithromycin recipients and 27.5% of placebo recipients. Azithromycin given once weekly is safe and effective in preventing disseminated MAC infection, death due to MAC infection, and respiratory tract infections in patients with AIDS and CD4 cell counts of <100/mm3.

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Collaboration types: Industry collaboration; Domestic collaboration
Citation topics: 1 Clinical & Life Sciences; 1.194 Tuberculosis & Leprosy; 1.194.273 Mycobacterium Tuberculosis
Web Of Science research areas: Immunology; Infectious Diseases; Microbiology
ESI research areas: Immunology

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Title: Once Weekly Azithromycin Therapy for Prevention of Mycobacterium avium Complex Infection in Patients with AIDS: A Randomized, Double-Blind, Placebo-Controlled Multicenter Trial
Creators: Edward C Oldfield - From the Naval Hospital, San Diego, and Kaiser Permanente, San Francisco, California; the Veterans Affairs Medical Center, Miami, Florida; the Walter Reed Army Medical Center, and the Military Medical Consortium for Applied Retroviral Research, Washington, D.C.; the Fitzsimmons Army Medical Center, Aurora, and the National Jewish Center for Immunology and Respiratory Medicine, Denver, Colorado; the National Naval Medical Center, Bethesda, Maryland; the Wilford Hall Medical Center, Lackland Air Force Base, San Antonio, and the Brooke Army Medical Center, Fort Sam Houston, Texas; the Dwight D. Eisenhower Army Medical Center, Fort Gordon, Georgia; the Naval Hospital, Portsmouth, Virginia; the Womack Army Medical Center, Fort Bragg, North Carolina; and Pfizer Central Research, Groton, Connecticut
W. Jeffrey Fessel - From the Naval Hospital, San Diego, and Kaiser Permanente, San Francisco, California; the Veterans Affairs Medical Center, Miami, Florida; the Walter Reed Army Medical Center, and the Military Medical Consortium for Applied Retroviral Research, Washington, D.C.; the Fitzsimmons Army Medical Center, Aurora, and the National Jewish Center for Immunology and Respiratory Medicine, Denver, Colorado; the National Naval Medical Center, Bethesda, Maryland; the Wilford Hall Medical Center, Lackland Air Force Base, San Antonio, and the Brooke Army Medical Center, Fort Sam Houston, Texas; the Dwight D. Eisenhower Army Medical Center, Fort Gordon, Georgia; the Naval Hospital, Portsmouth, Virginia; the Womack Army Medical Center, Fort Bragg, North Carolina; and Pfizer Central Research, Groton, Connecticut
Michael W Dunne - From the Naval Hospital, San Diego, and Kaiser Permanente, San Francisco, California; the Veterans Affairs Medical Center, Miami, Florida; the Walter Reed Army Medical Center, and the Military Medical Consortium for Applied Retroviral Research, Washington, D.C.; the Fitzsimmons Army Medical Center, Aurora, and the National Jewish Center for Immunology and Respiratory Medicine, Denver, Colorado; the National Naval Medical Center, Bethesda, Maryland; the Wilford Hall Medical Center, Lackland Air Force Base, San Antonio, and the Brooke Army Medical Center, Fort Sam Houston, Texas; the Dwight D. Eisenhower Army Medical Center, Fort Gordon, Georgia; the Naval Hospital, Portsmouth, Virginia; the Womack Army Medical Center, Fort Bragg, North Carolina; and Pfizer Central Research, Groton, Connecticut
Gordon Dickinson - From the Naval Hospital, San Diego, and Kaiser Permanente, San Francisco, California; the Veterans Affairs Medical Center, Miami, Florida; the Walter Reed Army Medical Center, and the Military Medical Consortium for Applied Retroviral Research, Washington, D.C.; the Fitzsimmons Army Medical Center, Aurora, and the National Jewish Center for Immunology and Respiratory Medicine, Denver, Colorado; the National Naval Medical Center, Bethesda, Maryland; the Wilford Hall Medical Center, Lackland Air Force Base, San Antonio, and the Brooke Army Medical Center, Fort Sam Houston, Texas; the Dwight D. Eisenhower Army Medical Center, Fort Gordon, Georgia; the Naval Hospital, Portsmouth, Virginia; the Womack Army Medical Center, Fort Bragg, North Carolina; and Pfizer Central Research, Groton, Connecticut
Mark R Wallace - From the Naval Hospital, San Diego, and Kaiser Permanente, San Francisco, California; the Veterans Affairs Medical Center, Miami, Florida; the Walter Reed Army Medical Center, and the Military Medical Consortium for Applied Retroviral Research, Washington, D.C.; the Fitzsimmons Army Medical Center, Aurora, and the National Jewish Center for Immunology and Respiratory Medicine, Denver, Colorado; the National Naval Medical Center, Bethesda, Maryland; the Wilford Hall Medical Center, Lackland Air Force Base, San Antonio, and the Brooke Army Medical Center, Fort Sam Houston, Texas; the Dwight D. Eisenhower Army Medical Center, Fort Gordon, Georgia; the Naval Hospital, Portsmouth, Virginia; the Womack Army Medical Center, Fort Bragg, North Carolina; and Pfizer Central Research, Groton, Connecticut
William Byrne - From the Naval Hospital, San Diego, and Kaiser Permanente, San Francisco, California; the Veterans Affairs Medical Center, Miami, Florida; the Walter Reed Army Medical Center, and the Military Medical Consortium for Applied Retroviral Research, Washington, D.C.; the Fitzsimmons Army Medical Center, Aurora, and the National Jewish Center for Immunology and Respiratory Medicine, Denver, Colorado; the National Naval Medical Center, Bethesda, Maryland; the Wilford Hall Medical Center, Lackland Air Force Base, San Antonio, and the Brooke Army Medical Center, Fort Sam Houston, Texas; the Dwight D. Eisenhower Army Medical Center, Fort Gordon, Georgia; the Naval Hospital, Portsmouth, Virginia; the Womack Army Medical Center, Fort Bragg, North Carolina; and Pfizer Central Research, Groton, Connecticut
Raymond Chung - From the Naval Hospital, San Diego, and Kaiser Permanente, San Francisco, California; the Veterans Affairs Medical Center, Miami, Florida; the Walter Reed Army Medical Center, and the Military Medical Consortium for Applied Retroviral Research, Washington, D.C.; the Fitzsimmons Army Medical Center, Aurora, and the National Jewish Center for Immunology and Respiratory Medicine, Denver, Colorado; the National Naval Medical Center, Bethesda, Maryland; the Wilford Hall Medical Center, Lackland Air Force Base, San Antonio, and the Brooke Army Medical Center, Fort Sam Houston, Texas; the Dwight D. Eisenhower Army Medical Center, Fort Gordon, Georgia; the Naval Hospital, Portsmouth, Virginia; the Womack Army Medical Center, Fort Bragg, North Carolina; and Pfizer Central Research, Groton, Connecticut
Kenneth F Wagner - From the Naval Hospital, San Diego, and Kaiser Permanente, San Francisco, California; the Veterans Affairs Medical Center, Miami, Florida; the Walter Reed Army Medical Center, and the Military Medical Consortium for Applied Retroviral Research, Washington, D.C.; the Fitzsimmons Army Medical Center, Aurora, and the National Jewish Center for Immunology and Respiratory Medicine, Denver, Colorado; the National Naval Medical Center, Bethesda, Maryland; the Wilford Hall Medical Center, Lackland Air Force Base, San Antonio, and the Brooke Army Medical Center, Fort Sam Houston, Texas; the Dwight D. Eisenhower Army Medical Center, Fort Gordon, Georgia; the Naval Hospital, Portsmouth, Virginia; the Womack Army Medical Center, Fort Bragg, North Carolina; and Pfizer Central Research, Groton, Connecticut
Scott F Paparello - From the Naval Hospital, San Diego, and Kaiser Permanente, San Francisco, California; the Veterans Affairs Medical Center, Miami, Florida; the Walter Reed Army Medical Center, and the Military Medical Consortium for Applied Retroviral Research, Washington, D.C.; the Fitzsimmons Army Medical Center, Aurora, and the National Jewish Center for Immunology and Respiratory Medicine, Denver, Colorado; the National Naval Medical Center, Bethesda, Maryland; the Wilford Hall Medical Center, Lackland Air Force Base, San Antonio, and the Brooke Army Medical Center, Fort Sam Houston, Texas; the Dwight D. Eisenhower Army Medical Center, Fort Gordon, Georgia; the Naval Hospital, Portsmouth, Virginia; the Womack Army Medical Center, Fort Bragg, North Carolina; and Pfizer Central Research, Groton, Connecticut
Daniel B Craig - From the Naval Hospital, San Diego, and Kaiser Permanente, San Francisco, California; the Veterans Affairs Medical Center, Miami, Florida; the Walter Reed Army Medical Center, and the Military Medical Consortium for Applied Retroviral Research, Washington, D.C.; the Fitzsimmons Army Medical Center, Aurora, and the National Jewish Center for Immunology and Respiratory Medicine, Denver, Colorado; the National Naval Medical Center, Bethesda, Maryland; the Wilford Hall Medical Center, Lackland Air Force Base, San Antonio, and the Brooke Army Medical Center, Fort Sam Houston, Texas; the Dwight D. Eisenhower Army Medical Center, Fort Gordon, Georgia; the Naval Hospital, Portsmouth, Virginia; the Womack Army Medical Center, Fort Bragg, North Carolina; and Pfizer Central Research, Groton, Connecticut
Gregory Melcher - From the Naval Hospital, San Diego, and Kaiser Permanente, San Francisco, California; the Veterans Affairs Medical Center, Miami, Florida; the Walter Reed Army Medical Center, and the Military Medical Consortium for Applied Retroviral Research, Washington, D.C.; the Fitzsimmons Army Medical Center, Aurora, and the National Jewish Center for Immunology and Respiratory Medicine, Denver, Colorado; the National Naval Medical Center, Bethesda, Maryland; the Wilford Hall Medical Center, Lackland Air Force Base, San Antonio, and the Brooke Army Medical Center, Fort Sam Houston, Texas; the Dwight D. Eisenhower Army Medical Center, Fort Gordon, Georgia; the Naval Hospital, Portsmouth, Virginia; the Womack Army Medical Center, Fort Bragg, North Carolina; and Pfizer Central Research, Groton, Connecticut
Margan Zajdowicz - From the Naval Hospital, San Diego, and Kaiser Permanente, San Francisco, California; the Veterans Affairs Medical Center, Miami, Florida; the Walter Reed Army Medical Center, and the Military Medical Consortium for Applied Retroviral Research, Washington, D.C.; the Fitzsimmons Army Medical Center, Aurora, and the National Jewish Center for Immunology and Respiratory Medicine, Denver, Colorado; the National Naval Medical Center, Bethesda, Maryland; the Wilford Hall Medical Center, Lackland Air Force Base, San Antonio, and the Brooke Army Medical Center, Fort Sam Houston, Texas; the Dwight D. Eisenhower Army Medical Center, Fort Gordon, Georgia; the Naval Hospital, Portsmouth, Virginia; the Womack Army Medical Center, Fort Bragg, North Carolina; and Pfizer Central Research, Groton, Connecticut
Richard F Williams - From the Naval Hospital, San Diego, and Kaiser Permanente, San Francisco, California; the Veterans Affairs Medical Center, Miami, Florida; the Walter Reed Army Medical Center, and the Military Medical Consortium for Applied Retroviral Research, Washington, D.C.; the Fitzsimmons Army Medical Center, Aurora, and the National Jewish Center for Immunology and Respiratory Medicine, Denver, Colorado; the National Naval Medical Center, Bethesda, Maryland; the Wilford Hall Medical Center, Lackland Air Force Base, San Antonio, and the Brooke Army Medical Center, Fort Sam Houston, Texas; the Dwight D. Eisenhower Army Medical Center, Fort Gordon, Georgia; the Naval Hospital, Portsmouth, Virginia; the Womack Army Medical Center, Fort Bragg, North Carolina; and Pfizer Central Research, Groton, Connecticut
J. William Kelly - From the Naval Hospital, San Diego, and Kaiser Permanente, San Francisco, California; the Veterans Affairs Medical Center, Miami, Florida; the Walter Reed Army Medical Center, and the Military Medical Consortium for Applied Retroviral Research, Washington, D.C.; the Fitzsimmons Army Medical Center, Aurora, and the National Jewish Center for Immunology and Respiratory Medicine, Denver, Colorado; the National Naval Medical Center, Bethesda, Maryland; the Wilford Hall Medical Center, Lackland Air Force Base, San Antonio, and the Brooke Army Medical Center, Fort Sam Houston, Texas; the Dwight D. Eisenhower Army Medical Center, Fort Gordon, Georgia; the Naval Hospital, Portsmouth, Virginia; the Womack Army Medical Center, Fort Bragg, North Carolina; and Pfizer Central Research, Groton, Connecticut
Michael Zelasky - From the Naval Hospital, San Diego, and Kaiser Permanente, San Francisco, California; the Veterans Affairs Medical Center, Miami, Florida; the Walter Reed Army Medical Center, and the Military Medical Consortium for Applied Retroviral Research, Washington, D.C.; the Fitzsimmons Army Medical Center, Aurora, and the National Jewish Center for Immunology and Respiratory Medicine, Denver, Colorado; the National Naval Medical Center, Bethesda, Maryland; the Wilford Hall Medical Center, Lackland Air Force Base, San Antonio, and the Brooke Army Medical Center, Fort Sam Houston, Texas; the Dwight D. Eisenhower Army Medical Center, Fort Gordon, Georgia; the Naval Hospital, Portsmouth, Virginia; the Womack Army Medical Center, Fort Bragg, North Carolina; and Pfizer Central Research, Groton, Connecticut
Leonid B Heifets - From the Naval Hospital, San Diego, and Kaiser Permanente, San Francisco, California; the Veterans Affairs Medical Center, Miami, Florida; the Walter Reed Army Medical Center, and the Military Medical Consortium for Applied Retroviral Research, Washington, D.C.; the Fitzsimmons Army Medical Center, Aurora, and the National Jewish Center for Immunology and Respiratory Medicine, Denver, Colorado; the National Naval Medical Center, Bethesda, Maryland; the Wilford Hall Medical Center, Lackland Air Force Base, San Antonio, and the Brooke Army Medical Center, Fort Sam Houston, Texas; the Dwight D. Eisenhower Army Medical Center, Fort Gordon, Georgia; the Naval Hospital, Portsmouth, Virginia; the Womack Army Medical Center, Fort Bragg, North Carolina; and Pfizer Central Research, Groton, Connecticut
Jonathan D Berman - From the Naval Hospital, San Diego, and Kaiser Permanente, San Francisco, California; the Veterans Affairs Medical Center, Miami, Florida; the Walter Reed Army Medical Center, and the Military Medical Consortium for Applied Retroviral Research, Washington, D.C.; the Fitzsimmons Army Medical Center, Aurora, and the National Jewish Center for Immunology and Respiratory Medicine, Denver, Colorado; the National Naval Medical Center, Bethesda, Maryland; the Wilford Hall Medical Center, Lackland Air Force Base, San Antonio, and the Brooke Army Medical Center, Fort Sam Houston, Texas; the Dwight D. Eisenhower Army Medical Center, Fort Gordon, Georgia; the Naval Hospital, Portsmouth, Virginia; the Womack Army Medical Center, Fort Bragg, North Carolina; and Pfizer Central Research, Groton, Connecticut
Publication Details: Clinical infectious diseases, Vol.26(3), pp.611-619
Publisher: The University of Chicago Press
Academic Unit: Miller School of Medicine; UMMG Dept of Medicine - Infectious Diseases
Language: English
Resource Type: Journal article
PMID: 9524832
Record Identifier: 991031598064902976