NCT06281834 Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention
| NCT ID | NCT06281834 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Brigham and Women's Hospital |
| Condition | Pediatric HIV Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-11-15 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 25 participants in total. It began in 2024-11-15 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Tuberculosis (TB) is the leading cause of death among children living with HIV, yet insufficient data are available on the pharmacokinetics of newer TB prevention strategies in children. Short-course TB prevention/latent TB infection (LTBI) treatment regimens increase completion rates but have not been adequately studied among children living with HIV. Our prospective, open-label PK study will examine and extend use of weekly rifapentine and isoniazid (3HP) among children receiving dolutegravir. This will address gaps in knowledge by examining two-way PK of short-course LTBI treatment in a vulnerable pediatric population.
Eligibility Criteria
Inclusion Criteria: * (1) ART-naïve or ART-experienced HIV-infected children 4 weeks to \<12 years of age; * (2) no evidence of active TB based on an appropriate clinical evaluation; * (3) negative TB diagnostic test if performed (other than tuberculin skin testing); * (4) weight of at least 4 kilograms; and * (5) consent of the parent or legal guardian and assent of the child (if ≥7 years of age). Exclusion Criteria: * (1) Baseline labs with evidence of ≥grade 3 abnormalities: alanine aminotransferase (ALT), total bilirubin, absolute neutrophil count (ANC), platelets, creatinine; * (2) presenting with acute respiratory distress or decompensation, or any clinical syndrome which could suggest undiagnosed TB or other opportunistic infection; or * (3) receipt of a medication that has drug-drug interactions with DTG or RPT.
Contact & Investigator
Holly Rawizza, MD, MPH
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT06281834 clinical trial?
This trial is open to participants of all sexes, aged 4 Weeks or older, up to 11 Years, studying Pediatric HIV Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06281834 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06281834 currently recruiting?
Yes, NCT06281834 is actively recruiting participants. Contact the research team at hrawizza@bwh.harvard.edu for enrollment information.
Where is the NCT06281834 trial being conducted?
This trial is being conducted at Ibadan, Nigeria.
Who is sponsoring the NCT06281834 clinical trial?
NCT06281834 is sponsored by Brigham and Women's Hospital. The principal investigator is Holly Rawizza, MD, MPH at Brigham and Women's Hospital. The trial plans to enroll 25 participants.
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