Treatment of Mycobacterium avium Complex Bacteremia in AIDS with a Four-Drug Oral Regimen
Rifampin, Ethambutol, Clofazimine, and Ciprofloxacin
- Carol A. Kemper, MD;
- Tze-Chiang Meng, MD;
- Joseph Nussbaum, MD;
- Joseph Chiu, MD;
- David F. Feigal, MD;
- Angie E. Bartok, MPH;
- John M. Leedom, MD;
- Jeremiah G. Tilles, MD;
- Stanley C. Deresinski, MD;
- J. Allen McCutchan, MD; and
- California Collaborative Treatment Group*
Abstract
▪ Objective: To determine the quantitative microbiologic response and the clinical response of patients with Mycobacterium avium complex bacteremia and AIDS to an oral antimycobacterial regimen.
▪ Design: A phase II, multicenter clinical trial.
▪ Setting: Four university-affiliated medical centers.
▪ Patients: Forty-one patients with HIV infection who had at least two consecutive blood cultures positive for M. avium complex and who had not received previous antimycobacterial therapy were enrolled in the study. Thirty-one patients were valuable with regard to the efficacy of the oral regimen.
▪ Interventions: Patients received a combination of orally administered rifampin (600 mg), ethambutol (15 mg/kg body weight), clofazimine (100 mg once daily), and ciprofloxacin (750 mg twice daily) for 12 weeks. Parenterally administered amikacin, 7.5 mg/kg daily for 4 weeks after the first 4 weeks of oral therapy, was used at the discretion of the individual investigator.
▪ Measurements: Clinical symptoms, Karnofsky scores, and adverse events were monitored. Colony counts for M. avium complex were determined.
▪ Main Results: The mean logarithmic (log) baseline colony count decreased from 2.1 to 0.7 after 4 weeks of oral therapy (P < 0.001). Suppression of bacteremia was sustained throughout therapy. Thirteen patients (42%) became culture negative during therapy. The mean duration of treatment was 9.7 weeks. Nineteen evaluable patients (61%) completed 12 weeks of therapy. Adverse reactions to one or more agents were common.
▪ Conclusions: A rapid reduction in symptoms and bacteremia can be achieved as early as week 2 of therapy using an oral regimen of rifampin, ethambutol, clofazimine, and ciprofloxacin. Colony counts rose dramaticallyafter therapy was discontinued, suggesting that more prolonged periods of therapy are necessary to eradicate systemic infection.
Article and Author Information
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For current author affiliations and addresses, see end of text.
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↵* See Appendix for a listing of the other members of the California Collaborative Treatment Group.
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Affiliation: From Santa Clara Valley Medical Center, San Jose, California; Stanford University School of Medicine, Stanford, California; University of California, San Diego, San Diego, California; University of Southern California-Los Angeles County Hospital, Los Angeles, California; and University of California, Irvine, Orange, California.
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Request for Reprints: Carol A. Kemper, MD, Division of Infectious Diseases, Santa Clara Valley Medical Center, 751 South Bascom Avenue, San Jose, CA 95128.
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Grant Support: In part by funds provided by the State of California's Universitywide AIDS Research Program (R90-CC86SD).
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Current Author Addresses: Dr. Kemper: Division of Infectious Diseases, Santa Clara Valley Medical Center, 751 South Bascom Avenue, Annex Room 137, San Jose, CA 95128.
Drs. Meng and McCutchan and Ms. Bartok: 2760 Fifth Avenue, Suite 300, San Diego, CA 92103.
Dr. Nussbaum: 201 South Alvarado, Suite 820, Los Angeles, CA 90057.
Dr. Chiu: P.O. Box 160, Chiang Mai 50000, Thailand.
Dr. Feigal: Division of Antiviral Drug Products, Nicholson Research Center, 5516 Nicholson Lane, 2nd floor, HFD-530, Kensington, Maryland 20895.
Dr. Leedom: University of Southern California-Los Angeles County Medical Center, Room 6442, 1200 North State Street, Los Angeles, CA 90033.
Dr. Tilles: University of California, Irvine, College of Medicine, Dean's Office, Irvine, CA 92717.
Dr. Deresinski: 77 Birch Street, Suite A, Redwood City, CA 94062.
- © 1992 American College of Physicians
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