TB Alliance and its partners conduct clinical trials in high TB burden countries around the world. A clinical trial may test one or more regimens simultaneously.
- TB Alliance and partners have developed child-friendly formulations of the current standard TB treatment. The first wave of these new products has already reached market.
- SimpliciTB is evaluating the efficacy, safety and tolerability of a novel and potentially shorter drug regimen (BPaMZ) for patients with drug-sensitive (DS) and drug-resistant (MDR-) pulmonary tuberculosis (specifically multidrug-resistant TB and mono-resistance to isoniazid and rifampicin). The BPaMZ regimen is comprised of four different antimicrobials: bedaquiline (B), pretomanid (Pa), moxifloxacin (M) and pyrazinamide (Z). The new drug regimen will be administered for four months to patients with DS-TB, and for six months to patients with MDR-TB or mono-resistance to rifampicin or isoniazid. Results in the DS-TB arm will be compared to a control group of the standard six-month drug regimen for DS-TB (HRZE).
- The purpose of this study was to evaluate the mycobactericidal activity, safety, tolerability, and pharmacokinetics of 5 doses of linezolid
- NC-001 was Phase II clinical trial that tested the PaMZ regimen (PA-824 + moxifloxacin + pyrazinamide). The regimen was administered for two weeks. Results found PaMZ could kill more than 99 percent of patients’ TB bacteria within two weeks and could be more effective than existing treatments.
- The New Combination 2 (NC-002) Phase 2 SSCC trial continued to develop the PaMZ TB treatment regimen, comprised of PA-824, moxifloxacin, and pyrazinamide. It was an 8-week trial, which recruited both DS-TB and MDR-TB patients.
- The New Combination 3 (NC-003) clinical trial tested the BPaZ regimen, consisting of bedaquiline, PA-824, and pyrazinamide. The two-week study found that the BPaZ regimen killed more than 99% of TB bacteria over the course of 14 days, and that the treatment was safe.
- NC-005 was a Phase 2B trial of the BPaZ and BPaMZ regimens to further explore their potential as improved TB treatments. This trial included people with drug-sensitive as well as people with some forms of multidrug-resistant TB.
- Nix-TB is a pivotal TB trial that tests the three-drug BPaL regimen, consisting of bedaquiline, pretomanid and linezolid – collectively referred to as the BPaL regimen. The trial enrolled 109 people with XDR-TB as well as treatment-intolerant or non-responsive MDR-TB. Nix-TB data have demonstrated a successful outcome in 95 of the first 107 patients after six months of treatment with BPaL and six months of post-treatment follow-up.
- REMoxTB was a global Phase 3 clinical trial conducted at nearly 50 sites. The trial tested whether substituting moxifloxacin for a single drug in the standard TB therapy could reduce treatment of drug-sensitive disease from six months to four.
- The STAND trial tested the novel three-drug regimen PaMZ in both DS-TB and MDR-TB patients.