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Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention
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.
Details
| Lead sponsor | Brigham and Women's Hospital |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 25 |
| Start date | 2024-11-15 |
| Completion | 2027-06 |
Conditions
- Pediatric HIV Infection
- Latent Tuberculosis
Interventions
- Rifapentine
- Dolutegravir
Primary outcomes
- Dolutegravir AUC during weekly rifapentine/isoniazid — Weeks 4 and 6
Dolutegravir area under the concentration time curve (AUC) will be compared to therapeutic ranges established in the adult and pediatric literature. Intensive PK sampling will occur at week 6 for dolutegravir and rifapentine PK. Week 4 sparse PK sampling will provide dolutegravir exposures without rifapentine.
Countries
Nigeria