Symptomatic and health status outcomes in the Canadian randomized MAC treatment trial (CTN010)

Joel Singer, Anona Thorne, Shideh Khorasheh, Janet M. Raboud, Albert W. Wu, Irving Salit, Christos M. Tsoukas, Claude Lemieux, Stephen D. Shafran

Research output: Contribution to journalArticle

Abstract

Our objective was to compare the effect of 2 regimens for treatment of Mycobacterium avium complex (MAC) bacteraemia in an HIV-positive population on symptoms and health status outcomes using a substudy of an open-label randomized controlled trial. The study was conducted in 24 hospital-based human immunodeficiency virus (HIV) clinics in 16 Canadian cities. Patients had HIV infection and MAC bacteraemia and were given either rifampin 600 mg, ethambutol 15 mg/kg daily, clofazimine 100 mg daily and ciprofloxacin 750 mg twice daily (4-drug arm) or rifabutin 600 mg daily (amended to 300 mg daily in mid-trial), ethambutol 15 mg/kg daily and clarithromycin 1000 mg twice daily (3-drug arm). The primary health status outcome was the change on the 8-item symptom subscale of the Medical Outcome Study (MOS)-HIV Health Survey adapted for MAC. Changes on other MOS-HIV subscales and on the Karnofsky score were also evaluated. Patients on the 3-drug arm had better outcomes on the MOS-HIV symptom subscale at 16 weeks (P = 0.06), with statistically significant differences restricted to night sweats and fever and chills (P < 0.001). The proportion of patients improving on the symptom subscale relative to baseline was 55% on the 3-drug arm and 40% on the 4-drug arm. Patients on the 3-drug arm also had better Karnofsky score at 16 weeks (P < 0.001) and better outcomes on the social function, mental health, energy/fatigue, health distress and cognitive function subscales of the MOS-HIV. The 3-drug arm is superior to the 4-drug arm in terms of impact on MAC-associated symptoms, functional status and other aspects of health status.

Original languageEnglish (US)
Pages (from-to)212-219
Number of pages8
JournalInternational Journal of STD and AIDS
Volume11
Issue number4
DOIs
StatePublished - Apr 6 2000

Keywords

  • AIDS
  • Health status
  • Mycobacterium avium complex
  • Randomized clinical trial

ASJC Scopus subject areas

  • Dermatology
  • Public Health, Environmental and Occupational Health
  • Pharmacology (medical)
  • Infectious Diseases

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    Singer, J., Thorne, A., Khorasheh, S., Raboud, J. M., Wu, A. W., Salit, I., Tsoukas, C. M., Lemieux, C., & Shafran, S. D. (2000). Symptomatic and health status outcomes in the Canadian randomized MAC treatment trial (CTN010). International Journal of STD and AIDS, 11(4), 212-219. https://doi.org/10.1258/0956462001915732