Title
A Phase IIA Dose Ranging Trial to Evaluate the Safety, Tolerability, Extended Early Bactericidal Activity and Pharmacokinetics of Higher Doses of Rifampicin in Adult Subjects With Newly Diagnosed, Uncomplicated, Smear-Positive, Pulmonary Tuberculosis
Intervention
Rifampicin
Study Arms
- Active Comparator: 10 mg/kg rifampicin
- Experimental: 20 mg/kg Rifampicin
- Experimental: 25 mg/kg Rifampicin
- Experimental: 30 mg/kg Rifampicin
- Experimental: 35 mg/kg Rifampicin
Primary Outcome Measures
- The incidence and severity of adverse events associated with increasing doses of rifampicin when administered as a single drug.
- The incidence and severity of adverse events associated with increasing doses of rifampicin when combined with isoniazid, pyrazinamide and ethambutol.