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Azacitidine Injection for Tuberculosis (AZA Trial)

Phase 1 & 2

Waitlist Available

Led By Andrew DiNardo

Research Sponsored by Andrew Dinardo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

AZA Trial Summary

This trial is looking at whether a drug called azacitidine is safe and can help the body resist tuberculosis. Tuberculosis is a contagious infection that attacks the lungs, and people with it are being asked to participate in this study. Some will receive the drug being tested while others will just receive the standard care for tuberculosis. Everyone in the study will continue to receive the standard care for tuberculosis.

Eligible Conditions

Tuberculosis

AZA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measurement of epigenetic-mediated immune exhaustion

Overall incidence of all IP-related adverse events

Overall severity of all IP-related adverse events

AZA Trial Design

1Treatment groups

Experimental Treatment

Group I: AZA TreatmentExperimental Treatment1 Intervention

In Phase Ib dose escalation stage, participants will receive subcutaneous (SQ) AZA once daily x 5 days. 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). All participants receive standard of care antibiotics against tuberculosis. Dose Escalation Strategy to identify the lowest dose of AZA that decreases DNA methylation and restores immune function is listed below. Proceeding to Phase IIa will proceed if stopping criteria are met at any of the steps below and FDA/IRB approval is obtained: 5 mg/m^2 subcutaneous (SQ) once daily x 5 days for 8 individuals 15 mg/m^2 subcutaneous (SQ) once daily x 5 days for 8 individuals 30 mg/m^2 subcutaneous (SQ) once daily x 5 days for 8 individuals 50 mg/m^2 SQ once daily x 5 days for 8 individuals 75 mg/m^2 once daily x 5 days for 8 individuals

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azacitidine Injection

2021

Completed Phase 2

~60

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor

2,639 Previous Clinical Trials

4,129,032 Total Patients Enrolled

1 Trials studying Tuberculosis

2,000 Patients Enrolled for Tuberculosis

Andrew DinardoLead Sponsor

Andrew DiNardoPrincipal InvestigatorBaylor College of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you outline the precedent studies done with Azacitidine Injection?

"Currently, 173 Azacitidine Injection trials are in progress with 32 of them in Phase 3. Missouri's Saint Louis is the epicentre for many clinical studies on this drug, but there are 5,664 sites where you can find a trial."

Answered by AI

What is the enrollment rate of participants for this clinical trial?

"At this juncture, there are no openings in the trial. The initial post date was September 1st 2022 and it was most recently updated on that same day. If you are looking for alternative clinical trials, currently 174 researches dealing with tuberculosis or pulmonary issues have available positions, as do 173 studies involving Azacitidine Injection therapy."

Answered by AI

Are there vacancies for participants in the present trial?

"Unfortunately, this research project is not currently accepting applicants. The study was announced on September 1st 2022 and had its most recent update that same day. If you are interested in similar trials, there are 174 clinical studies presently looking for patients with tuberculosis or pulmonary difficulties, as well as 173 more searching for participants to receive Azacitidine Injection treatments."

Answered by AI

What indications might necessitate a prescription for Azacitidine Injection?

"Azacitidine Injection has been known to treat malignant neoplasms, a 20-30% blast count, and low counts of circulating neutrophils or platelets in the bloodstream."

Answered by AI

Recent research and studies

mycobacterium TuberculosisJournal

Schistosome Soluble Egg Antigen Decreases<i>mycobacterium Tuberculosis</i>–specific Cd4<sup>+</sup>t-cell Effector Function with Concomitant Arrest of Macrophage Phago-lysosome Maturation

DiNardo, Andrew R., Emily M. Mace, Kelsey Lesteberg, Jeffrey D. Cirillo, Anna M. Mandalakas, Edward A. Graviss, Jordan S. Orange, and George Makedonas. 2016. “Schistosome Soluble Egg Antigen Decreasesmycobacterium Tuberculosis–specific Cd4+t-cell Effector Function with Concomitant Arrest of Macrophage Phago-lysosome Maturation”. Journal of Infectious Diseases. Oxford University Press (OUP). doi:10.1093/infdis/jiw156.

The Journal of ImmunologyJournal

Cutting Edge: Prolonged Exposure to HIV Reinforces a Poised Epigenetic Program for PD-1 Expression in Virus-specific CD8 T Cells

Youngblood, Ben, Alessandra Noto, Filippos Porichis, Rama S. Akondy, Zaza M. Ndhlovu, James W. Austin, Rebeka Bordi, et al.. 2013. “Cutting Edge: Prolonged Exposure to HIV Reinforces a Poised Epigenetic Program for PD-1 Expression in Virus-specific CD8 T Cells”. The Journal of Immunology. The American Association of Immunologists. doi:10.4049/jimmunol.1203161.

Seminars in ImmunologyJournal

Mendelian Susceptibility to Mycobacterial Disease: Genetic, Immunological, and Clinical Features of Inborn Errors of Ifn-γ Immunity

Bustamante, Jacinta, Stéphanie Boisson-Dupuis, Laurent Abel, and Jean-Laurent Casanova. 2014. “Mendelian Susceptibility to Mycobacterial Disease: Genetic, Immunological, and Clinical Features of Inborn Errors of Ifn-γ Immunity”. Seminars in Immunology. Elsevier BV. doi:10.1016/j.smim.2014.09.008.

Clinical Cancer ResearchJournal