NCT01691534

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

A Phase 2 Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of the Following: 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, and Clofazimine Alone; in Adult Patients With Newly Diagnosed, Smear-Positive Pulmonary Tuberculosis.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Global Alliance for TB Drug Development · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Tuberculosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-04-01
• Completion: 2013-05-01
• First posted: 2012-09-24
• Last updated: 2016-12-13
• Results posted: 2016-12-13

Locations

2 sites across 1 country: South Africa