NCT01691534 (NC-003) is a Phase 2 clinical trial of TMC207 (J) in Pulmonary Tuberculosis, sponsored by Global Alliance for TB Drug Development.

Who is sponsoring NCT01691534?

NCT01691534 is sponsored by Global Alliance for TB Drug Development.

What drugs are being tested in NCT01691534?

Interventions in NCT01691534: TMC207 (J), PA-824 (PA), pyrazinamide (Z), clofazimine (C), Rifafour.

What condition does NCT01691534 study?

NCT01691534 studies Pulmonary Tuberculosis.

Is NCT01691534 still recruiting?

NCT01691534 is currently completed. Last updated 19 October 2016.

Are results published for NCT01691534?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2016-10-19 · How we verify

NCT01691534: NC-003

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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.

Completed Phase 2 Results posted Last updated 19 October 2016

What this trial tests

Phase 2 trial testing TMC207 (J) in Pulmonary Tuberculosis in 105 participants. Completed in 1 May 2013.

Timeline

1 October 2012

Primary endpoint
1 April 2013

1 May 2013

Quick facts

Lead sponsor	Global Alliance for TB Drug Development
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	105
Start date	1 October 2012
Primary completion	1 April 2013
Estimated completion	1 May 2013
Sites	2 locations across South Africa

Drugs / interventions tested

TMC207 (J) — full drug profile →
PA-824 (PA) — full drug profile →
pyrazinamide (Z) — full drug profile →
clofazimine (C) — full drug profile →
Rifafour — full drug profile →

Conditions studied

Pulmonary Tuberculosis — all drugs for Pulmonary Tuberculosis →

Sponsor

Global Alliance for TB Drug Development — full company profile →

Who can join

Adults 18 to 65, any sex, with Pulmonary Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-14).
Time frame: 14 consecutive days of treatment

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis.
Nahid P, Dorman SE, Alipanah N, Barry PM, et al · · 2016 · cited 829× · PMID 27516382 · DOI 10.1093/cid/ciw376
New agents for the treatment of drug-resistant Mycobacterium tuberculosis.
Hoagland DT, Liu J, Lee RB, Lee RE. · · 2016 · cited 218× · PMID 27151308 · DOI 10.1016/j.addr.2016.04.026
Perspectives on Advances in Tuberculosis Diagnostics, Drugs, and Vaccines.
Schito M, Migliori GB, Fletcher HA, McNerney R, et al · · 2015 · cited 77× · PMID 26409271 · DOI 10.1093/cid/civ609
Safety and availability of clofazimine in the treatment of multidrug and extensively drug-resistant tuberculosis: analysis of published guidance and meta-analysis of cohort studies.
Hwang TJ, Dotsenko S, Jafarov A, Weyer K, et al · · 2014 · cited 54× · PMID 24384902 · DOI 10.1136/bmjopen-2013-004143
Contribution of the nitroimidazoles PA-824 and TBA-354 to the activity of novel regimens in murine models of tuberculosis.
Tasneen R, Williams K, Amoabeng O, Minkowski A, et al · · 2015 · cited 43× · PMID 25331697 · DOI 10.1128/aac.03822-14
New anti-tuberculosis drugs and regimens: 2015 update.
D'Ambrosio L, Centis R, Sotgiu G, Pontali E, et al · · 2015 · cited 42× · PMID 27730131 · DOI 10.1183/23120541.00010-2015
Evaluation of two line probe assays for rapid detection of Mycobacterium tuberculosis, tuberculosis (TB) drug resistance, and non-TB Mycobacteria in HIV-infected individuals with suspected TB.
Luetkemeyer AF, Kendall MA, Wu X, Lourenço MC, et al · · 2014 · cited 37× · PMID 24430455 · DOI 10.1128/jcm.02639-13
Recent advances in tuberculosis: New drugs and treatment regimens.
Sloan DJ, Davies GR, Khoo SH. · · 2013 · cited 31× · PMID 24683386 · DOI 10.2174/1573398x113099990017

Verify or expand the search:

Other recruiting trials for Pulmonary Tuberculosis

Currently open trials in the same condition.

NCT07209761 — A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis · Phase 3 · recruiting
NCT06192160 — Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis · Phase 2 · recruiting
NCT07186478 — I-FALMIN Albumin Supplement for Patients With Pulmonary Tuberculosis · NA · active not recruiting
NCT06649721 — Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort · Phase 3 · active not recruiting
NCT06528418 — Identification of Multiple Pulmonary Diseases Using Volatile Organic Compounds Biomarkers in Human Exhaled Breath · recruiting

Other Global Alliance for TB Drug Development trials

Trials by the same sponsor.

NCT05526911 — A Phase 1, Drug-Drug Interaction Study of TBAJ-876 in Healthy Adults · Phase 1 · completed
NCT04179500 — A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary · Phase 2 · completed
NCT04865536 — Study to Evaluate Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects · Phase 1 · completed
NCT04890535 — Evaluation of the Safety, Tolerability, PK of TBAJ-587 in Healthy Adults · Phase 1 · completed
NCT04493671 — Evaluate Safety, Tolerability, PK of TBAJ-876 in Healthy Adults · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01691534 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Global Alliance for TB Drug Development
Last refreshed: 19 October 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01691534.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing