Evaluating drug levels in children with HIV receiving TB prevention treatment
Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention
This study is testing how well two medications work in children with HIV who are getting treatment to prevent tuberculosis, to see if they are safe and effective for different age groups.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 4 Weeks to 11 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Ibadan, Oyo State) |
| Trial ID | NCT06281834 on ClinicalTrials.gov |
What this trial studies
This study investigates the pharmacokinetics of dolutegravir and rifapentine in children living with HIV who are receiving treatment for latent tuberculosis infection. It is a prospective, open-label study that will assess drug concentrations in two age groups: children aged 2-11 years receiving standard treatment and children under 2 years receiving a single dose of rifapentine. The study aims to fill knowledge gaps regarding TB prevention strategies in this vulnerable population. Participants will be recruited from pediatric HIV clinics in Nigeria, and the study will involve intensive blood sampling to monitor drug levels and safety.
Who should consider this trial
Good fit: Ideal candidates are HIV-infected children aged 4 weeks to under 12 years who are ART-naïve or ART-experienced and have no evidence of active TB.
Not a fit: Patients with significant baseline lab abnormalities or those presenting with acute respiratory distress or other clinical syndromes suggesting undiagnosed TB may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve TB prevention strategies in children living with HIV, potentially reducing mortality rates.
How similar studies have performed: While studies on TB prevention in adults have shown success, this specific approach in young children is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ibadan, Oyo State
- University College Hospital — Ibadan, Oyo State, Nigeria (Recruiting)
Study contacts
- Principal investigator: Holly Rawizza, MD, MPH — Brigham and Women's Hospital
- Study coordinator: Holly Rawizza, MD, MPH
- Email: hrawizza@bwh.harvard.edu
- Phone: 617-432-4686
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.