Symptomatic and health status outcomes in the Canadian randomized MAC treatment trial (CTN010). Canadian HIV Trials Network Protocol 010 Study Group.
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.
Singer
J
J
Canadian HIV Trials Network, St Paul's Hospital, Vancouver, BC. joel@hivnet.ubc.ca
Thorne
A
A
Khorasheh
S
S
Raboud
J M
JM
Wu
A W
AW
Salit
I
I
Tsoukas
C M
CM
Lemieux
C
C
Shafran
S D
SD
D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy* / Q000503:physiopathology; D000293:Adolescent; D000328:Adult; D000995:Antitubercular Agents / Q000627:therapeutic use*; D016470:Bacteremia / Q000188:drug therapy* / Q000503:physiopathology; D002170:Canada; D002939:Ciprofloxacin / Q000627:therapeutic use; D017291:Clarithromycin / Q000627:therapeutic use; D002991:Clofazimine / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D004977:Ethambutol / Q000627:therapeutic use; D006304:Health Status; D006801:Humans; D015270:Mycobacterium avium-intracellulare Infection / Q000188:drug therapy* / Q000503:physiopathology; D010043:Outcome and Process Assessment, Health Care; D017828:Rifabutin / Q000627:therapeutic use; D012293:Rifampin / Q000627:therapeutic use; D016896:Treatment Outcome
D000995:Antitubercular Agents; D017828:Rifabutin; D002939:Ciprofloxacin; D004977:Ethambutol; D002991:Clofazimine; D017291:Clarithromycin; D012293:Rifampin