A Phase 2 to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis.

PHASE2CompletedINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

October 23, 2014

Primary Completion Date

February 8, 2016

Study Completion Date

February 7, 2018

Conditions
Tuberculosis
Interventions
DRUG

PA-824

oral

DRUG

bedaquiline

oral

DRUG

moxifloxacin

oral

DRUG

pyrazinamide

oral

DRUG

isoniazid, rifampicin, pyrazinamide and ethambutol combination tablet

oral

Trial Locations (10)

1632

The Aurum Institute: Tembisa Hospital, Tembisa

2570

Klerksdorp Tshepong Hospital, Jouberton

7531

TASK Applied Science, Cape Town

7937

University of Cape Town Lung Institute (Pty) Ltd, Cape Town

Unknown

THINK: Tuberculosis & HIV Investigative Network of KwaZulu-Natal, Durban

CHRU Themba Lethu Clinic, Johannesburg

University of Witwatersrand, Clinical HIV Research Unit (CHRU), Helen Joseph Hospital, Johannesburg

Ifakara Health Institute, Bagamoyo

NIMR-Mbeya Medical Research Centre (MMRC), Mbeya

Uganda Case Western Reserve University Research Collaboration, Kampala

All Listed Sponsors
lead

Global Alliance for TB Drug Development

OTHER

NCT02193776 - A Phase 2 to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis. | Biotech Hunter | Biotech Hunter