Study results published August 2021. Link to publication below.
In this prospective, open-label, phase 2, randomised controlled trial, patients with pulmonary tuberculosis were recruited at three clinical sites in South Africa. Eligible patients were aged 18–65 years, HIV-1-negative, and had rifampicin-susceptible Mycobacterium tuberculosis, a sputum Xpert cycle threshold of less than 20, and moderately advanced or far advanced disease on chest radiography. By use of numbers generated in blocks of ten and stratification by site, eligible patients were randomly assigned (1:1:1:1:1) to receive one of the four oral host-directed treatments plus standard tuberculosis treatment or standard treatment alone (the control group). Host-directed treatments were: CC-11050 (200 mg twice daily, taken with food; day 1–112); everolimus (0·5 mg/day; day 1–112); auranofin (3 mg/day for seven doses, then 6 mg/day; day 1–112); and ergocalciferol (5 mg on day 1, then 2·5 mg on day 28 and day 56). All study participants received oral rifabutin-substituted standard tuberculosis treatment for 180 days. Patients and clinicians were not masked to treatment assignment. Spirometry and sputum culture with solid and liquid media were done at baseline and up to 180 days at specified intervals throughout treatment. The primary endpoint was safety and tolerability up to day 210.
To examine the safety and preliminary efficacy of multiple adjunctive host directed TB therapies (TB HDT), to assess their potential to shorten TB treatment and/or prevent permanent lung damage.
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 2HRbEZ/4HRb
2HRbZE
|
Drug: 2HRbZE/4HRb
Other Name: rifabutin-modified TB therapy
|
| Experimental: Everolimus
Everolimus 0.5 MG
|
Drug: Everolimus 0.5 MG Drug: 2HRbZE/4HRb
Other Name: rifabutin-modified TB therapy
|
| Experimental: Auranofin
Auranofin 6 MG
|
Drug: Auranofin 6 MG Drug: 2HRbZE/4HRb
Other Name: rifabutin-modified TB therapy
|
| Experimental: Vitamin D
Vitamin D3 5 mg -> 2.5 mg
|
Drug: Vitamin D3 Drug: 2HRbZE/4HRb
Other Name: rifabutin-modified TB therapy
|
| Experimental: CC-11050
CC-11050 200 mg BID
|
Drug: CC-11050 Drug: 2HRbZE/4HRb
Other Name: rifabutin-modified TB therapy
|
Registry Link