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

Our objective was to compare the effect of 2 regimens for treatment of Myco bacterium avium complex (MAC) bacteraemia in an HIV-positive population on symptoms and health status outcomes using a substudy of an open-label rando mized controlled trial. The study was conducted in 24 hospital-based human immunodeficiency virus (HIV) clinics in 16 Canadian cities. Patients had HI V infection and MAC bacteraemia and were given either rifampin 600 mg, etha mbutol 15 mg/kg daily, clofazimine 100 mg daily and ciprofloxacin 750 mg tw ice daily (4-drug arm) or rifabutin 600 mg daily (amended to 300 mg daily i n mid-trial), ethambutol 15 mg/kg daily and clarithromycin 1000 mg twice da ily (3-drug arm). The primary health status outcome was the change on the g -item symptom subscale of the Medical Outcome Study (MOS)-HIV Health Sun ey adapted for MAC. Changes on other MOS-HIV subscales and on the Karnofsky s core were also evaluated. Patients on the 3-drug arm had better outcomes on the MOS-HIV symptom subsc ale at 16 weeks (P=0.06), with statistically significant differences restri cted to night sweats and fever and chills (P < 0.001). The proportion of pa tients improving on the symptom subscale relative to baseline was 55% on th e 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 cognit ive 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 a nd other aspects of health status.