TY - JOUR
T1 - A Prospective, Randomized Trial Examining the Efficacy and Safety of Clarithromycin in Combination with Ethambutol, Rifabutin, or Both for the Treatment of Disseminated Mycobacterium avium Complex Disease in Persons with Acquired Immunodeficiency Syndrome
AU - Benson, Constance A.
AU - Williams, Paige L.
AU - Currier, Judith S.
AU - Holland, Fiona
AU - Mahon, Laura F.
AU - MacGregor, Rob Roy
AU - Inderlied, Clark B.
AU - Flexner, Charles
AU - Neidig, Judith
AU - Chaisson, Richard
AU - Notario, Gerard F.
AU - Hafner, Richard
N1 - Funding Information:
Financial support: National Institute of Allergy and Infectious Diseases, National Institutes of Health (grants U01 AI38858 to the Adult AIDS Clinical Trials Group and U01 AI38855 to P.L.W. and F.H. [for statistical support]). Abbott Laboratories supplied clarithromycin and ritonavir, Lederle Laboratories supplied ethambutol, Pharmacia & Upjohn supplied rifabutin, and Merck supplied indinavir to study subjects during the course of this trial.
PY - 2003/11/1
Y1 - 2003/11/1
N2 - This multicenter, randomized, open-label phase 3 clinical trial compared the safety and efficacy of 3 clarithromycin-containing combination regimens for the treatment of disseminated Mycobacterium avium complex (MAC) disease in persons with acquired immunodeficiency syndrome. A total of 160 eligible patients with bacteremic MAC disease were randomized to receive clarithromycin with either ethambutol (C+E), rifabutin (C+R), or both (C+E+R) for 48 weeks. After 12 weeks of treatment, the proportion of subjects with a complete microbiologic response was not statistically significantly different among treatment arms: the proportion was 40% in the C+E group, 42% in the C+R group, and 51% in the C+E+R group (P = .454). The proportion of patients with complete or partial responses who experienced a relapse while receiving C+R (24%) was significantly higher than that of patients receiving C+E+R (6%; P = .027) and marginally higher than that of patients receiving C+E (7%; P = .057). Subjects in the C+E+R group had improved survival, compared with the C+E group (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.23-0.83) and the C+R group (HR, 0.49; 95% CI, 0.26-0.92).
AB - This multicenter, randomized, open-label phase 3 clinical trial compared the safety and efficacy of 3 clarithromycin-containing combination regimens for the treatment of disseminated Mycobacterium avium complex (MAC) disease in persons with acquired immunodeficiency syndrome. A total of 160 eligible patients with bacteremic MAC disease were randomized to receive clarithromycin with either ethambutol (C+E), rifabutin (C+R), or both (C+E+R) for 48 weeks. After 12 weeks of treatment, the proportion of subjects with a complete microbiologic response was not statistically significantly different among treatment arms: the proportion was 40% in the C+E group, 42% in the C+R group, and 51% in the C+E+R group (P = .454). The proportion of patients with complete or partial responses who experienced a relapse while receiving C+R (24%) was significantly higher than that of patients receiving C+E+R (6%; P = .027) and marginally higher than that of patients receiving C+E (7%; P = .057). Subjects in the C+E+R group had improved survival, compared with the C+E group (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.23-0.83) and the C+R group (HR, 0.49; 95% CI, 0.26-0.92).
UR - http://www.scopus.com/inward/record.url?scp=0242490748&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0242490748&partnerID=8YFLogxK
U2 - 10.1086/378807
DO - 10.1086/378807
M3 - Article
C2 - 14557969
AN - SCOPUS:0242490748
SN - 1058-4838
VL - 37
SP - 1234
EP - 1243
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
IS - 9
ER -