NCT02968927

TB Host Directed Therapy

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: The Aurum Institute NPC · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: To determine the safety and preliminary efficacy of 4 TB HDT candidates: 1. Safety (treatment emergent serious adverse events and SUSARs) 2. Microbiologic effects in sputum (culture conversion, change in MGIT TTP) and blood (WBA) 3. PET/CT imaging 4. Serum markers of inflammation 5. Effects on Mtb-specific and general immune function 6. Pulmonary effects (spirometry, 6MWT, O2 saturation, and St. George Respiratory Symptom Questionnaire) In each case, TB HDT effects will be determined by comparison to patients treated with standard TB therapy alone with regard to a common set of primary and secondary endpoints. PRIMARY ENDPOINTS 1. For auranofin, everolimus, and vitamin D: the proportions of patients experiencing suspected unexpected serious adverse reactions (SUSARs). 2. For CC-11050: the proportion of patients experiencing treatment emergent serious adverse events (SAEs).

Conditions

• Tuberculosis

Interventions

Type	Name	Description
DRUG	Everolimus 0.5 MG
DRUG	Auranofin 6 MG
DRUG	Vitamin D3
DRUG	CC-11050
DRUG	2HRbZE/4HRb

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-09-01
• Completion: 2020-12-01
• First posted: 2016-11-21
• Last updated: 2019-01-10

Locations

1 site across 1 country: South Africa