A phase II/III trial of antimicrobial therapy with or without amikacin in the treatment of disseminated Mycobacterium avium infection in HIV-infected individuals. AIDS Clinical Trials Group Protocol 135 Study Team.

Autor:	Parenti DM; George Washington University Medical Center, Washington, DC 20037, USA., Williams PL, Hafner R, Jacobs MR, Hojczyk P, Hooton TM, Barber TW, Simpson G, van der Horst C, Currier J, Powderly WG, Limjoco M, Ellner JJ
Jazyk:	angličtina
Zdroj:	AIDS (London, England) [AIDS] 1998 Dec 24; Vol. 12 (18), pp. 2439-46.
DOI:	10.1097/00002030-199818000-00013
Abstrakt:	Objective: To determine the clinical and microbiologic benefit of adding amikacin to a four-drug oral regimen for treatment of disseminated Mycobacterium avium infection in HIV-infected patients. Design: A randomized, open-labeled, comparative trial. Setting: Outpatient clinics. Patients: Seventy-four patients with HIV and symptomatic bacteremic M. avium infection. Interventions: Rifampin 10 mg/kg daily, ciprofloxacin 500 mg twice daily, clofazimine 100 mg every day, and ethambutol 15 mg/kg orally daily for 24 weeks, with or without amikacin 10 mg/kg intravenously or intramuscularly 5 days weekly for the first 4 weeks. Main Outcome Measure: Clinical and microbiologic response at 4 weeks; quantitative level of bacteremia with M. avium. Results: No difference in clinical response was noted with the addition of amikacin to the four-drug oral regimen, and only 25% in either group had a complete or partial response at 4 weeks. A comparable quantitative decrease in bacteremia was noted in both treatment groups, with 16% of patients being culture-negative at 4 weeks and 38% at 12 weeks. Toxicities were mainly gastrointestinal. Amikacin was well tolerated. Median survival was 30 weeks in both groups. Conclusions: The addition of amikacin to a four-drug oral regimen of rifampin, ciprofloxacin, clofazimine, and ethambutol did not provide clinical or microbiologic benefit.
Databáze:	MEDLINE
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