Actively Recruiting
Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin
Led by Brigham and Women's Hospital · Updated on 2025-12-02
20
Participants Needed
1
Research Sites
177 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 with HIV, yet insufficient data are available on the pharmacokinetics of newer HIV/TB cotreatment strategies in children. Current WHO-recommended rifampicin dosages result in low concentrations in most children, and high-dose rifampicin may improve outcomes and shorten treatment duration. Yet the impact of high-dose rifampicin on dolutegravir exposures has not been examined in children. This study aims to evaluate the safety and pharmacokinetics of dolutegravir twice daily among HIV/TB coinfected children receiving standard-dose and high-dose rifampicin.
CONDITIONS
Official Title
Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged between 4 weeks and under 6 years with HIV infection
- Diagnosed with active tuberculosis
- Weighing at least 3 kilograms
- Parent or legal guardian provides consent
You will not qualify if you...
- Significant lab abnormalities at baseline including grade 3 or higher in ALT, total bilirubin, neutrophil count, platelets, or creatinine
- Suspected TB meningitis or acute respiratory distress or decompensation
- Use of medications that interact with dolutegravir or rifampicin
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University College Hospital/ University of Ibadan
Ibadan, Oyo State, 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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