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Azacytidine During Anti-tuberculosis Therapy

NCT03941496 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2023-02-08

No results posted yet for this study

Summary

Tuberculosis has been shown to make immune genes inaccessible and slows immune response The purpose of this research is to see if if azacitidine is safe and can return the ability of the body to resist tuberculosis (TB), a contagious infection that attacks the lungs. Individuals with tuberculosis are being asked to participate. Some will receive a drug to restore a host immunity while others can choose to receive standard of care. All patients will continue to receive standard of care tuberculosis therapy regardless of whether they chose to participate in the study.

This study is a Phase Ib/IIa single-institution, open-label, non-randomized clinical trial of sub-cutaneous azacitidine in pulmonary TB patients during the continuation phase of ATT.

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

Sponsors & Collaborators

Principal Investigators

  • Andrew DiNardo · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2023-05-31
Completion
2023-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03941496 on ClinicalTrials.gov