RecruitingPhase 1NCT06281834

Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention

Sponsor

Brigham and Women's Hospital

Enrollment

25 participants

Start Date

Nov 15, 2024

Study Type

INTERVENTIONAL

Conditions

Pediatric HIV Infection Latent Tuberculosis

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

Min Age: 4 WeeksMax Age: 11 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how a common HIV treatment drug (dolutegravir) interacts with TB prevention medications (rifapentine and isoniazid given once weekly) in HIV-positive children. Understanding how these drugs interact helps doctors safely treat both HIV and prevent tuberculosis in young patients. **You may be eligible if...** - Your child is HIV-positive and between 4 weeks and 12 years of age - Your child weighs at least 4 kilograms - There is no evidence of active tuberculosis - You (as parent or guardian) consent to participate, and the child assents if 7 or older **You may NOT be eligible if...** - Your child has significant abnormalities in liver function, blood counts, or kidney function - Your child has signs of active TB or a serious respiratory illness - Your child is taking medications that would interact dangerously with the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRifapentine

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.

DRUGDolutegravir

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