180
Participants
Start Date
September 30, 2013
Primary Completion Date
April 30, 2016
Study Completion Date
April 30, 2016
Higher-Dose Rifampin
The intervention phase of this trial will last 8 weeks. During that time, subjects will receive the following companion drugs: isoniazid (INH, 5 mg/kg/day), ethambutol (EMB, 20 mg/kg/day), and pyrazinamide (PZA, 25 mg/kg/day), pyridoxine (50 mg), the standard doses used in treatment. Subjects will also be randomized to receive one of the following weight-based doses of the study drug, rifampin (RIF): 10 mg/kg/day (standard dose, control), 15 mg/kg/day (intervention 1), 20 mg/kg/day (intervention 2). All patients will receive at least standard dose of RIF, the efficacy of which in multidrug-treatment for TB is well established. Placebo will be used to control only the additional RIF capsules provided in the intervention arms.
University of Florida, Gainesville
Socios En Salud Sucursal Perú, Lima
School of Clinical Sciences at University of Liverpool, Liverpool
St. George's University of London, London
Collaborators (1)
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Sanofi
INDUSTRY
Harvard School of Public Health (HSPH)
OTHER
Brigham and Women's Hospital
OTHER
University of Liverpool
OTHER
St George's, University of London
OTHER
University of Florida
OTHER
Socios en Salud
UNKNOWN
Harvard University Faculty of Medicine
OTHER