Azacytidine During Anti-tuberculosis Therapy

PHASE1/PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

October 31, 2022

Primary Completion Date

May 31, 2023

Study Completion Date

May 31, 2023

Conditions
Tuberculosis, Pulmonary
Interventions
DRUG

Azacitidine Injection

"In Phase Ib dose escalation stage, 24 participants will receive AZA subcutaenously once a day for 5 days as follows:~1. 5 mg/m\^2~2. 15 mg/m\^2~3. 30 mg/m\^2~4. 50 mg/m\^2~5. 75 mg/m\^2~Results from Phase Ib are sent to FDA/IRB for approval before proceeding to Phase IIa. 36 subjects will receive AZA treatment in total (Phase Ib/IIa). Subjects in Phase II will receive a dose that induces two of the three following:~1. a decrease DNA methylation levels in genes previously identified to be persistently hyper-methylated despite successful anti-TB therapy~2. an increase in TNF and IFN-γ signaling pathways~3. an increase in ex vivo mycobacterial growth inhibition assay"

Trial Locations (1)

77030

Harris Health System - Ben Taub Hospital, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Andrew Dinardo

OTHER