drugset / Trial / NCT06281834
Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention
Phase 1
Recruiting
25 enrolled
Brigham and Women's Hospital
APIN Public Health Initiatives · collabUniversity of Cape Town · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-11-15
- Primary completion
- 2027-02
- Completion
- 2027-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dolutegravir | Other / unclassified | — | — |
| Subject | Rifapentine | Small molecule | — | — |