NCT01691534View on ClinicalTrials.gov

Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With Clofazimine (C)-TMC207 (J)-PA-824 (Pa)-Pyrazinamide (Z)

PHASE2CompletedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

April 30, 2013

Study Completion Date

May 31, 2013

Conditions
Pulmonary Tuberculosis
Interventions
DRUG

TMC207 (J)

TMC207 400 mg Day 1; 300mg Day 2; 200mg Days 3-14

DRUG

PA-824 (PA)

PA-824 200mg Days 1-14

DRUG

pyrazinamide (Z)

1500mg Days 1-14 Dosed by Weight

DRUG

clofazimine (C)

clofazimine 300mg Days 1-3 and clofazimine 100mg Days 4-14

DRUG

Rifafour

Rifafour e-275 mg dosed by weight

Trial Locations (2)

Unknown

Centre for Tuberculosis Research Innovation, UCT Lung Institute, Cape Town

Task Applied Science, Karl Bremer Hospita, Cape Town

All Listed Sponsors
lead

Global Alliance for TB Drug Development

OTHER

NCT01691534 - Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With Clofazimine (C)-TMC207 (J)-PA-824 (Pa)-Pyrazinamide (Z) | Biotech Hunter | Biotech Hunter