Phase 1 Tuberculosis Trial, Recruiting NCT06318416 Sponsor: University of Virginia Condition: Tuberculosis
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Phase 1 Tuberculosis Trial, Recruiting

NCT06318416
Recruiting Phase 1

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 are 3 years of age or older
  • You have been diagnosed with active tuberculosis (TB) in the lungs that can be treated with the antibiotic rifampin, confirmed by a lab test (or, for young children who cannot cough up a sample, diagnosed using standard medical guidelines)
  • You are starting a standard four-drug TB treatment plan that includes isoniazid, rifampin, pyrazinamide, and ethambutol
  • You (or your parent/guardian) are able to give written permission to participate, and children aged 7 and older must also agree to take part
  • You are willing and able to follow all the steps of the trial for its full duration
  • You live within a specific local area that allows you to attend follow-up visits at a TB clinic

Who may not be able to join:

  • You have trouble controlling your bladder (urinary incontinence), as this could make urine collection difficult
  • You produce very little urine, as this could affect how urine samples are collected and measured
  • You have reduced kidney function (confirm with trial site for specific test results)
  • You have severe anemia, meaning your blood has very low levels of hemoglobin (confirm with trial site for specific test results), since blood draws are part of the trial
  • Your liver enzyme levels are significantly elevated, based on a blood test (confirm with trial site for specific levels)
  • You are pregnant or could become pregnant without using a highly effective form of birth control — a pregnancy test will be done at the start of the trial for those who could potentially become pregnant
  • You weigh less than 10 kg (approximately 22 pounds)
  • You are currently taking another medication that is known to interact significantly with TB treatment drugs
  • You drink alcohol heavily — for example, more than 14 drinks per week or more than 4 drinks in a day if male, or more than 7 drinks per week or more than 3 drinks in a day if female (or as judged by the trial doctor)

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 1: approximately ~10% 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

Phone: 4342439064

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.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
1 October 2025
Est. completion
30 December 2027

Where this trial is recruiting

Tanzania

Primary endpoints

Rifampin serum area under the concentration time curve for the 24 hour dosing interval; Adverse events

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