Table 1:
Ongoing clinical trials of treatment of multidrug-resistant TB in PLWH and HIV-uninfected individuals
| Name of trial | Study population | Study groups | Description | Status |
|---|---|---|---|---|
| NiX-TB (NCT02333799) | 109 participants enrolled, HIV− and HIV + adults (aged ≥18 years) | 6 months bedaquiline (400 mg daily for 2 weeks then 200 mg three times weekly), pretomanid (200 mg daily), linezolid (600 mg twice daily), | Phase 3 trial assessing the safety and efficacy of bedaquiline, pretomanid as well as linezolid in subjects with pulmonary infection of either XDR-TB, treatment-intolerant tuberculosis, or pre-XDR non-responsive MDR-TB | Active but not recruiting. Expected completion July 2020 |
| NC-008 SimpliciTB (NCT03338621) | 455 participants enrolled, HIV− and HIV + adults (aged ≥18 years) | 6 months bedaquiline, pretomanid, moxifloxacin, pyrazinamide daily, single arm study | Phase 2 trial evaluating the efficacy, safety and tolerability of bedaquiline, pretomanid, moxifloxacin Plus Pyrazinamide (BPaMZ) compared to a 6-month Treatment of HRZE/HR (Control) in Adult Participants With Drug-Sensitive Smear-Positive Pulmonary Tuberculosis (DS-TB) and a 6-month Treatment of BPaMZ in Adult Participants With Drug Resistant, Smear-Positive Pulmonary Tuberculosis (DR-TB) | Active but not recruiting. results expected February 2022 |
| IMPAACT 2005 (NCT03141060) | 48 participants enrolled, HIV− and HIV + children (aged <18 years) | Pharmacokinetics, safety 6 months delamanid (100 mg twice daily) plus Optimised multi-drug background regimen (OBR), single arm study | This phase 1–2 study will evaluate the pharmacokinetics, safety, and tolerability of the anti-tuberculosis (TB) drug delamanid (DLM) in combination with an optimised multi-drug background regimen (OBR) for MDR-TB in HIV-infected and HIV-uninfected children with MDR-TB. | Recruitment ongoing. Completion date November 2022 |
| endTB (NCT02754765) | 750 participants enrolled, HIV− and HIV + adults (aged ≥18 years) | 9 months bedaquiline, linezolid, moxifloxacin, pyrazinamide daily, or 9 months of bedaquiline, linezolid, clofazimine, levofloxacin, pyrazinamide daily, or 9 months of bedaquiline, linezolid, delamanid, levofloxacin, pyrazinamide daily, or 9 months of delamanid, linezolid, clofazimine, levofloxacin, pyrazinamide daily, or 9 months of delamanid, clofazimine, moxifloxacin, pyrazinamide daily vs local regimen as per WHO guidelines |
This Phase 3 trial will evaluate the efficacy and safety of five new, all-oral, shortened regimens for MDR-TB. | Recruitment ongoing. Estimated completion date April 2021 |
| TB-PRACTECAL (NCT02589782) | 630 participants enrolled, HIV− and HIV + adults (aged ≥18 years) | 6 months bedaquiline, pretomanid, moxifloxacin, linezolid daily,or 6 months bedaquiline, pretomanid, linezolid, clofazimine daily,or 6 months bedaquiline, pretomanid, linezolid daily (all oral) vs local regimen | This phase 2–3 trial evaluating short treatment regimens containing bedaquiline and pretomanid in combination with existing and repurposed anti-TB drugs for the treatment of biologically confirmed pulmonary MDR-TB. | Recruitment ongoing. Estimated date of completion March 2021 |
| NExT 5001 (NCT02454205) | 154 participants enrolled, HIV− and HIV + adults (aged ≥18 years) | 6–9 months bedaquiline, linezolid, levofloxacin, pyrazinamide and either high-dose isoniazid or ethionamide or terizidone daily (all oral) vs 6–8 months kanamycin, moxifloxacin, pyrazinamide, ethionamide, terizidone daily, and 16–18 months moxifloxacin | phase 2–3 trial investigating a new treatment regimen for patients with MDR-TB | Active, not recruiting. Estimated date of completion December 2020 |