The purpose of this study is to evaluate the potential of high doses of rifampin (RIF) to
shorten treatment for tuberculosis (TB) without causing more adverse events. The hypotheses
are that higher doses of RIF will result in higher blood concentrations of RIF; higher blood
concentrations will result in tuberculosis bugs being killed more quickly; and, both of these
will happen without more adverse events. Patients with active, infectious, drug-susceptible
TB who agree to participate will be randomly assigned to 1 of 3 doses of RIF. All patients
will also receive standard doses of regular (3) companion drugs for 2 months of daily,
supervised therapy. The study will assess the following among the 3 study arms (oral doses of
RIF 10, 15 & 20 mg/kg/day) during the initial 8 weeks of treatment: 1) the amount of RIF in
the blood after at least 14 days of treatment; 2) the difference in the number of
tuberculosis bugs killed; 3) the frequency of adverse events.
Phase:
Phase 2
Details
Lead Sponsor:
Harvard University Faculty of Medicine
Collaborators:
Brigham and Women's Hospital Harvard School of Public Health Harvard School of Public Health (HSPH) National Institute of Allergy and Infectious Diseases (NIAID) Sanofi Socios en Salud St George's, University of London University of Florida University of Liverpool