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Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention
Sponsor: Brigham and Women's Hospital
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.
Key Details
Gender
All
Age Range
4 Weeks - 11 Years
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2024-11-15
Completion Date
2027-06
Last Updated
2024-12-24
Healthy Volunteers
No
Interventions
Rifapentine
Children 2-11 years received standard HIV treatment and 3HP (RPT/INH weekly for 12 weeks) for TB prevention. Children \<2 years receive standard HIV treatment, a single-dose of extrapolated weekly RPT/INH, followed by standard INH prophylaxis. Safety and pharmacokinetics will be evaluated.
Dolutegravir
All children in this study are living with HIV and thus dolutegravir is a standard part of treatment; in this study we will collect blood samples to measure dolutegravir levels during combination treatment with rifapentine/isoniazid treatment for TB prevention
Locations (1)
University College Hospital
Ibadan, Oyo State, Nigeria