Phase 3 Tuberculosis Trial, Recruiting (NCT06497465)

Phase 3 Tuberculosis Trial, Recruiting NCT06497465 Sponsor: Johns Hopkins University Condition: Tuberculosis

Printed from Voxsanity (voxsanity.com.au) — NCT06497465 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

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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:

People who have a confirmed HIV-1 diagnosis, proven through standard HIV testing methods such as rapid tests, blood tests, or measurements of the virus in the blood.
People whose recent blood test (taken within the last 30 days) shows a CD4+ immune cell count of at least 50 cells per cubic millimetre — CD4+ cells are a type of white blood cell that HIV affects.
People whose HIV virus level in the blood is 1,000 copies per millilitre or higher, meaning the virus is detectable and active.
People who have never previously taken antiretroviral therapy (ART), which is the standard medication used to treat HIV.
People who have a confirmed diagnosis of pulmonary tuberculosis (TB affecting the lungs).

Who may not be able to join:

People who are currently pregnant or who are planning to become pregnant.

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 28 July 2026

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Ethel M Weld, MD, Johns Hopkins University

Phone: 410 614 3812

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: NCT06497465

Sponsor: Johns Hopkins University

Phase: Phase 3

Status: Recruiting

Condition: Tuberculosis

Trial contact: 410 614 3812

More information: https://clinicaltrials.gov/study/NCT06497465

Eligibility summary (AI generated)

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

Who might be able to join this trial:

People who have a confirmed HIV-1 diagnosis, proven through standard HIV testing methods such as rapid tests, blood tests, or measurements of the virus in the blood.
People whose recent blood test (taken within the last 30 days) shows a CD4+ immune cell count of at least 50 cells per cubic millimetre — CD4+ cells are a type of white blood cell that HIV affects.
People whose HIV virus level in the blood is 1,000 copies per millilitre or higher, meaning the virus is detectable and active.
People who have never previously taken antiretroviral therapy (ART), which is the standard medication used to treat HIV.
People who have a confirmed diagnosis of pulmonary tuberculosis (TB affecting the lungs).

Who may not be able to join:

People who are currently pregnant or who are planning to become pregnant.

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 28 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

Phase 3

Sponsor

Johns Hopkins University

Registry

ClinicalTrials.gov

Start date

18 September 2025

Est. completion

31 January 2028

Where this trial is recruiting

🇧🇷 Brazil

Primary endpoints

Among treatment-naïve participants with HIV-1 who are taking rifampin-based regimens for TB, determine the proportion with HIV-1 virologic suppression (via FDA snapshot algorithm) at 28 weeks of HIV treatment, by arm

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: 28 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