Randomized, placebo-controlled trial of rifampin, ethambutol, and ciprofloxacin for AIDS patients with disseminated Mycobacterium avium complex infection

J Infect Dis. 1993 Jul;168(1):112-9. doi: 10.1093/infdis/168.1.112.

Abstract

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 > or = 1 log/mL in 4 of 9 treated patients versus 0 of 10 placebo recipients while increasing by > or = 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 rifampin [corrected]-ethambutol-ciprofloxacin therapy for disseminated MAC infection had significant microbiologic efficacy with some evidence of clinical efficacy but was associated with drug intolerance.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • AIDS-Related Opportunistic Infections / drug therapy*
  • Adult
  • Ciprofloxacin / pharmacokinetics
  • Ciprofloxacin / therapeutic use*
  • Double-Blind Method
  • Drug Synergism
  • Drug Therapy, Combination
  • Ethambutol / pharmacokinetics
  • Ethambutol / therapeutic use*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Mycobacterium avium-intracellulare Infection / complications
  • Mycobacterium avium-intracellulare Infection / drug therapy*
  • Rifampin / pharmacokinetics
  • Rifampin / therapeutic use*

Substances

  • Ciprofloxacin
  • Ethambutol
  • Rifampin