Phase 1 Tuberculosis Trial, Recruiting (NCT05069688)

Phase 1 Tuberculosis Trial, Recruiting NCT05069688 Sponsor: Brigham and Women's Hospital Condition: Tuberculosis

Printed from Voxsanity (voxsanity.com.au) — NCT05069688 — 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:

Children living with HIV who are between 4 weeks and under 6 years of age, whether or not they have previously received HIV treatment
Children who have been diagnosed with active tuberculosis (TB)
Children who weigh at least 3 kilograms
Children whose parent or legal guardian has given consent for them to participate

Who may not be able to join:

Children whose baseline blood test results show significant abnormalities (graded as level 3 or higher) in liver enzymes, bilirubin, white blood cell counts, platelets, or kidney function markers (confirm with trial site)
Children who are suspected to have TB affecting the brain or membranes around it (TB meningitis), or who are experiencing serious breathing difficulties or rapid deterioration in their condition
Children who are currently taking any medication that is known to interact with either dolutegravir or rifampicin (two of the medicines used in this trial)

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

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.

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: NCT05069688

Sponsor: Brigham and Women's Hospital

Phase: Phase 1

Status: Recruiting

Condition: Tuberculosis

Trial contact: 617-432-4686

More information: https://clinicaltrials.gov/study/NCT05069688

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:

Children living with HIV who are between 4 weeks and under 6 years of age, whether or not they have previously received HIV treatment
Children who have been diagnosed with active tuberculosis (TB)
Children who weigh at least 3 kilograms
Children whose parent or legal guardian has given consent for them to participate

Who may not be able to join:

Children whose baseline blood test results show significant abnormalities (graded as level 3 or higher) in liver enzymes, bilirubin, white blood cell counts, platelets, or kidney function markers (confirm with trial site)
Children who are suspected to have TB affecting the brain or membranes around it (TB meningitis), or who are experiencing serious breathing difficulties or rapid deterioration in their condition
Children who are currently taking any medication that is known to interact with either dolutegravir or rifampicin (two of the medicines used in this trial)

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 1

Sponsor

Brigham and Women's Hospital

Registry

ClinicalTrials.gov

Start date

7 July 2023

Est. completion

1 December 2026

Where this trial is recruiting

Nigeria

Primary endpoints

Dolutegravir AUC during standard-dose rifampicin; Dolutegravir AUC during high-dose rifampicin

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