Nix-TB is the first clinical trial to test a novel regimen that holds the potential to be a shorter, all-oral, and affordable treatment for XDR-TB. The Nix-TB regimen consists of drugs with minimal resistance, pretomanid, bedaquiline, and linezolid. Participants will be treated with the intent to cure for 6-9 months. Nix-TB is an open label trial that enables patients to be assessed at regular intervals. The trial has an adaptive design, which can accommodate the addition of new treatments or treatment protocols over the course of study, based on new information generated.
People suffering from XDR-TB have very few treatment options – cure rates are extremely low and mortality rates are extremely high. Nix-TB is the world’s first clinical trial to study an XDR-TB drug regimen with only pills – no injections – and minimal pre-existing resistance. The trial tests a three-drug regimen consisting of bedaquiline, pretomanid, and linezolid.
Nix-TB enrolls participants at XDR-TB at sites in Africa and Eastern Europe. It can include patients as young as 14 and those who are co-infected with HIV with a CD4 count of 50 or higher. Nix-TB is an open-label trial that enables participants to be assessed at regular intervals with the aim of being cured in six to nine months. After completing treatment, participants are monitored for two years to ensure they do not relapse. The trial has an adaptive design; if improved treatments become available during the course of the study, they can be incorporated into the trial. The trial is designed to accommodate up to 200 patients.
Nix-TB is a partnership between TB Alliance, the sponsor of the trial; Janssen Pharmaceuticals, the discoverer of bedaquiline; and the sites where the study is being conducted. The study may expand to include other partners and sites.
About the New Treatment(s)
The Nix-TB regimen consists of bedaquiline, which received conditional regulatory approval in several high-TB disease burden countries; the novel antibacterial drug compound pretomanid, which is being tested in multiple clinical trials for TB; and linezolid, an oxazolidinone that has been used off-label to treat TB. This combination is predicted to be able to cure XDR-TB in six to nine months.
If successful, the injection-free regimen being tested in Nix-TB could transform XDR-TB treatment, with patients being cured by taking a relatively short, simple, and effective regimen. Importantly, the regimen being tested could reduce the complexity and cost of the treatment to a fraction of what it is today, facilitating the global implementation of XDR-TB treatment in resource-poor nations.
Nix-TB began in Q2 2014. Nix-TB is scheduled to report findings on an ongoing basis at predetermined milestones.
- A Phase 3 Study Assessing the Safety and Efficacy of Bedaquiline Plus PA-824 Plus Linezolid in Subjects With Drug Resistant Pulmonary Tuberculosis
- TB Alliance Launches “Nix-TB” Clinical Trial to Test New XDR-TB Treatment (news release)
- Nix-TB: Testing a New Potential Treatment for XDR-TB (fact sheet)
- Long-term outcomes of patients with extensively drug-resistant tuberculosis in South Africa: a cohort study
- A Study To Assess The Effect Of Linezolid On QTc Interval
- The Nix-TB trial of pretomanid, bedaquiline and linezolid to treat XDR-TB (scientific abstract, CROI 2017)