Actively Recruiting
Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention
Led by Brigham and Women's Hospital · Updated on 2024-12-24
25
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
A
APIN Public Health Initiatives
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ART-naive or ART-experienced HIV-infected children aged 4 weeks to under 12 years
- No signs of active tuberculosis based on clinical evaluation
- Negative tuberculosis test if performed (excluding tuberculin skin test)
- Weigh at least 4 kilograms
- Consent from parent or legal guardian and assent from child if 7 years or older
You will not qualify if you...
- Laboratory tests showing grade 3 or higher abnormalities in liver enzymes, bilirubin, neutrophils, platelets, or creatinine
- Presenting with severe respiratory distress, clinical signs of undiagnosed tuberculosis, or other opportunistic infections
- Taking medications that interact with dolutegravir or rifapentine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University College Hospital
Ibadan, Oyo State, Nigeria, Nigeria
Actively Recruiting
Research Team
H
Holly Rawizza, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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