Conditions: Pulmonary Tuberculosis
Keywords: Tuberculosis EBA PA824 pretomanid TMC207
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 105
Healthy volunteers: no

Brief summary:
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 plus PA-824 plus Pyrazinamide plus Clofazimine, TMC207 plus PA-824 plus Pyrazinamide, TMC207 plus PA-824 plus Clofazimine alone, TMC207 plus Pyrazinamide plus Clofazimine, Pyrazinamide alone, Clofazimine alone, and standard first line TB treatment as per South African TB Guidelines (Rifafour e-275) as determined by the rate of change of log CFU per ml sputum over the time period Day 0-14 in participants with smear positive pulmonary tuberculosis (TB). A control group will receive standard treatment.

Detailed description:

Arms:
arm 1: TMC207 400 mg Day 1; 300mg Day 2; 200mg Days 3-14 plus PA-824 200mg Days 1-14 plus pyrazinamide 1500mg Days 1-14 plus clofazimine 300mg Days 1-3 and Clofazamine 100mg Days 4-14 arm 2: TMC207 400 mg Day 1; 300mg Day 2; 200mg Days 3-14 plus PA-824 200mg Days 1-14 plus pyrazinamide 1500mg Days 1-14 arm 3: TMC207 400 mg Day 1; 300mg Day 2; 200mg Days 3-14 plus PA-824 200mg Days 1-14 plus clofazimine 300mg Days 1-3 and clofazimine 100mg Days 4-14 arm 4: TMC207 400 mg Day 1; 300mg Day 2; 200mg Days 3-14 plus pyrazinamide 1500mg Days 1-14 plus clofazimine 300mg Days 1-3 and Clofazimine 100mg Days 4-14 arm 5: pyrazinamide 1500mg Days 1-14 arm 6: Clofazimine 300mg Days 1-3 and Clofazimine 100mg Days 4-14 arm 7: Rifafour e-275 mg dosed by weight

Interventions: intervention 1: TMC207 (J) intervention 2: PA-824 (PA) intervention 3: pyrazinamide (Z) intervention 4: clofazimine (C) intervention 5: Rifafour
Intervention descriptions: intervention 1: TMC207 400 mg Day 1; 300mg Day 2; 200mg Days 3-14 intervention 2: PA-824 200mg Days 1-14 intervention 3: 1500mg Days 1-14 Dosed by Weight intervention 4: clofazimine 300mg Days 1-3 and clofazimine 100mg Days 4-14 intervention 5: Rifafour e-275 mg dosed by weight

Protocol document: