Randomized, Placebo-Controlled Trial of Rifampin, Ethambutol, and Ciprofloxacin for AIDS Patients with Disseminated Mycobacterium avium Complex Infection

Patients with AIDS and disseminated Mycobacterium avium complex (MAC) infection received rifampin (600 mg) plus ethambutol (25 mg/kg) plus ciprofloxacin (750 mg) or matching placebos daily for 8 weeks. Patients were monitored every 2 weeks clinically and by quantitating MAC colony-forming units (cfu...

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Bibliographic Details
Published in:The Journal of infectious diseases 1993-07, Vol.168 (1), p.112-119
Main Authors: Jacobson, Mark A., Yajko, David, Northfelt, Donald, Charlebois, Edwin, Gary, David, Brosgart, Carol, Sanders, Cynthia A., Hadley, W. Keith
Format: Article
Language:English
Subjects:
Adult
AIDS
AIDS-Related Opportunistic Infections - drug therapy
Biological and medical sciences
Blood
Ciprofloxacin - pharmacokinetics
Ciprofloxacin - therapeutic use
Double-Blind Method
Drug Synergism
Drug Therapy, Combination
Ethambutol - pharmacokinetics
Ethambutol - therapeutic use
Experimentation
Female
Fever
Health outcomes
Humans
Immunodeficiencies
Immunodeficiencies. Immunoglobulinopathies
Immunopathology
Infections
Major Articles
Male
Medical sciences
Middle Aged
Mycobacterium avium
Mycobacterium avium complex
Mycobacterium avium-intracellulare Infection - complications
Mycobacterium avium-intracellulare Infection - drug therapy
Nausea
Placebos
Rifampin - pharmacokinetics
Rifampin - therapeutic use
Synergism
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Summary:Patients with AIDS and disseminated Mycobacterium avium complex (MAC) infection received rifampin (600 mg) plus ethambutol (25 mg/kg) plus ciprofloxacin (750 mg) or matching placebos daily for 8 weeks. Patients were monitored every 2 weeks clinically and by quantitating MAC colony-forming units (cfu) per milliliter of blood. Analysis of baseline characteristics revealed no significant differences between groups. After 8 weeks, MAC cfu had decreased by ⩾1 log/mL in 4 of 9 treated patients versus 0 of 10 placebo recipients while increasing by ⩾1 log/mL, in 1 and 7, respectively (P = .006). While the average combined clinical response score declined in both groups, it tended to decrease less in treated patients (P = .36). On the other hand, dose-limiting toxicity (primarily nausea and adverse drug interactions) occurred in 9 of 12 treatment versus 1 of 12 placebo patients (P = .005). Combined rifabutin-ethambutol-ciprofloxacin therapy for disseminated MAC infection had significant microbiologic efficacy with some evidence of clinical efficacy but was associated with drug intolerance.
ISSN:0022-1899
1537-6613
DOI:10.1093/infdis/168.1.112