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Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients

Sponsored by Global Alliance for TB Drug Development

About this trial

Last updated a year ago

Study ID

SimpliciTB (B-Pa-M-Z) NC-008

Status

Completed

Type

Interventional

Phase

Phase 2/Phase 3

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 3 years ago

What is this trial about?

To evaluate the efficacy, safety and tolerability at 8 weeks (2-months), 52 weeks (12-months), and 104 Weeks (24-months) post the start of the following treatment regimens in participants with: Drug Sensitive TB (DS-TB) patients given BPaMZ for 17 Weeks ( or 4 months) vs. Standard HRZE/HR treatment given for 26 weeks (or 6 months) and Drug Resistant TB (DR-TB) patients given BPaMZ for 26 Weeks (or 6 months)

What are the participation requirements?

Yes

Inclusion Criteria

- Sputum positive for tubercule bacilli (at least 1+ on the International Union Against Tuberculosis and Lung Disease [IUATLD]/WHO scale (Appendix 1) on smear microscopy) at the trial laboratory. - Participants with one of the following pulmonary TB conditions: DS-TB treatment arm participants should be: - sensitive to rifampicin and isoniazid by rapid sputum based test AND - either newly diagnosed for TB or have a history of being untreated for at least 3 years after cure from a previous episode of TB. DR-TB treatment arm participants should be Resistant to rifampicin and/or isoniazid. - Of non-childbearing potential or willing to practice effective methods of birth control - Body weight (in light clothing and no shoes) ≥ 30 kg. - Completed informed consent form

No

Exclusion Criteria

- Karnofsky score <60% - Any risk factor for QT prolongation - Any planned contraindicated medicines - Resistant to fluoroquinolones (rapid, sputum-based molecular screening tests). Any of the following lab toxicities/abnormalities: - CD4+ count < 100 cells/µL (HIV infected participants) - platelets <75,000/mm³ - creatinine >1.5 times upper limit of normal (ULN) - eGFR ≤ 60 mL/min - haemoglobin <8.0 g/dL - serum potassium less than the lower limit of normal for the laboratory. - GGT: greater than 3 x ULN - AST: ≥3.0 x ULN to be excluded; - ALT: ≥3.0 x ULN to be excluded - ALP: ≥3.0 x ULN to be excluded - Total bilirubin: >1.5 x ULN to be excluded; - Direct bilirubin: greater than 1x ULN to be excluded

Locations

Location

Status