Trial

A Ph2 Randomized Trial to Evaluate the Safety Preliminary Efficacy and Biomarker Response of Host Directed Therapies Added to Rifabutin-modified Standard Therapy in Adults With Drug-Sensitive Smear-Positive Pulmonary TB

Study Director
Start Date
12 / 2016
Trial Phase
Phase II
Trial Status
in data analysis
Current Enrollment
200 (Sept 2018)
Target Enrollment
200
Overview
Data to be presented at the American Thoracic Society Meeting May 2019 as a Late Breaker.
 
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