Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
Symptomatic and health status outcomes in the Canadian randomized MAC treatment trial (CTN010). Canadian HIV Trials Network Protocol 010 Study Group.
Int J STD AIDS. 2000 Apr;11(4):212-9. Unique Identifier : AIDSLINE MED/20233037 Singer J; Thorne A; Khorasheh S; Raboud JM; Wu AW; Salit I; Tsoukas CM; Lemieux C; Shafran SD; Canadian HIV Trials Network, St Paul's Hospital, Vancouver, BC.; joel@hivnet.ubc.ca
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.
Keywords: CLINICAL TRIAL JOURNAL ARTICLE MULTICENTER STUDY RANDOMIZED CONTROLLED TRIAL Adolescence Adult Antitubercular Agents/*THERAPEUTIC USE AIDS-Related Opportunistic Infections/*DRUG THERAPY/ PHYSIOPATHOLOGY Bacteremia/*DRUG THERAPY/PHYSIOPATHOLOGY Canada Ciprofloxacin/THERAPEUTIC USE Clarithromycin/THERAPEUTIC USE Clofazimine/THERAPEUTIC USE Comparative Study Drug Therapy, Combination Ethambutol/THERAPEUTIC USE Health Status Human Mycobacterium avium-intracellulare Infection/*DRUG THERAPY/ PHYSIOPATHOLOGY Outcome and Process Assessment (Health Care) Rifabutin/THERAPEUTIC USE Rifampin/THERAPEUTIC USE Support, Non-U.S. Gov't Treatment Outcome
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Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
