Tuberculosis Trial, Recruiting (NCT05633056)

Tuberculosis Trial, Recruiting NCT05633056 Sponsor: Columbia University Condition: Tuberculosis

Printed from Voxsanity (voxsanity.com.au) — NCT05633056 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Tuberculosis

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

You have been diagnosed with tuberculosis (TB) confirmed by a lab culture or a molecular test.
You have tested positive for HIV, or have a documented history of being HIV positive.
Your TB has been found to be resistant to at least one key TB medication called rifampicin, confirmed by testing.
You are starting a TB treatment plan that includes a medication called bedaquiline within 4 weeks of joining the trial, and you have never taken bedaquiline before.
You are currently taking HIV treatment (antiretroviral therapy), including a combination that may contain a medicine called dolutegravir, or you will be starting this within 4 weeks of joining the trial.
You are able to give informed consent and can communicate in either isiZulu or English.

Who may not be able to join:

You are currently pregnant.
You are currently in prison or detained.
The lead researcher or your treating doctor decides, based on their judgment, that participation is not appropriate for you (confirm with trial site).

⚠️ Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 23 July 2026

This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Max O'Donnell, MD, MPH, Columbia University

Phone: +27 31 260 4687

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT05633056

Sponsor: Columbia University

Phase: Not Applicable

Status: Recruiting

Condition: Tuberculosis

Trial contact: +27 31 260 4687

More information: https://clinicaltrials.gov/study/NCT05633056

Eligibility summary (AI generated)

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You have been diagnosed with tuberculosis (TB) confirmed by a lab culture or a molecular test.
You have tested positive for HIV, or have a documented history of being HIV positive.
Your TB has been found to be resistant to at least one key TB medication called rifampicin, confirmed by testing.
You are starting a TB treatment plan that includes a medication called bedaquiline within 4 weeks of joining the trial, and you have never taken bedaquiline before.
You are currently taking HIV treatment (antiretroviral therapy), including a combination that may contain a medicine called dolutegravir, or you will be starting this within 4 weeks of joining the trial.
You are able to give informed consent and can communicate in either isiZulu or English.

Who may not be able to join:

You are currently pregnant.
You are currently in prison or detained.
The lead researcher or your treating doctor decides, based on their judgment, that participation is not appropriate for you (confirm with trial site).

⚠️ Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 23 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Not Applicable

Sponsor

Columbia University

Registry

ClinicalTrials.gov

Start date

7 March 2023

Est. completion

1 April 2027

Where this trial is recruiting

🇿🇦 South Africa

Primary endpoints

Biological outcome; Clinical outcome; Biological outcome; Clinical outcome; Biological outcome

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov