Phase 1 Tuberculosis Trial, Recruiting NCT06281834 Sponsor: Brigham and Women's Hospital Condition: Tuberculosis
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Phase 1 Tuberculosis Trial, Recruiting

NCT06281834
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:

  • Children with HIV who are between 4 weeks and under 12 years old, whether or not they have previously taken HIV medications
  • Children who show no signs of active tuberculosis (TB) based on a medical check-up
  • Children whose TB test results came back negative, if a test was done (note: this does not apply to the skin-prick TB test)
  • Children who weigh at least 4 kilograms (about 8.8 pounds)
  • Children whose parent or legal guardian agrees to take part, and the child themselves agrees if they are 7 years old or older

Who may not be able to join:

  • Children whose blood test results show seriously abnormal levels of certain liver, blood, or kidney markers (such as liver enzymes, bilirubin, white blood cells, platelets, or creatinine) (confirm with trial site)
  • Children who are currently having serious breathing problems or a rapid decline in health, or who show symptoms that might suggest undiagnosed TB or another serious infection
  • Children who are taking any medication that is known to interact badly with either of the two study drugs (called DTG or RPT) (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 22 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

Principal Investigator: Holly Rawizza, MD, MPH, Brigham and Women's Hospital

Phone: 617-432-4686

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
15 November 2024
Est. completion
1 February 2027

Where this trial is recruiting

Nigeria

Primary endpoints

Dolutegravir AUC during weekly rifapentine/isoniazid

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: 22 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