Actively Recruiting
Mind the Gaps: Pharmacokinetic Research to Advance Pediatric HIV/TB Cotreatment and TB Prevention
Led by Brigham and Women's Hospital · Updated on 2025-12-02
20
Participants Needed
1
Research Sites
N/A
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 a leading cause of death in children with HIV, but there is limited data on how newer treatments for HIV and TB work together in children. Current recommended doses of rifampicin often result in low drug levels, and higher doses may improve treatment results and shorten therapy. This study aims to evaluate the safety and drug levels of dolutegravir given twice daily in children with HIV and TB receiving both standard and high doses of rifampicin. This is a prospective, open-label study involving 20 children aged from 4 weeks to under 6 years who have both HIV and TB and need TB treatment. Participants will be divided into two age groups: 4 weeks to under 2 years and 2 to under 6 years. All children will receive standard HIV/TB treatment including dolutegravir twice daily with rifampicin-containing TB therapy. At weeks 20-21, rifampicin dose will be increased to a high dose for two weeks to study drug levels and safety. Blood samples will be collected at weeks 20, 22, and 30 to measure drug concentrations and an enzyme biomarker to better understand drug actions. Participants will undergo blood sampling for drug levels and biomarker tests during the 48-week study. Safety and toxicity will be monitored with clinical and lab tests consistent with usual care. The main outcomes measured are dolutegravir drug levels during standard and high-dose rifampicin treatments. Secondary outcomes include rifampicin peak levels and occurrence of severe side effects. This study helps guide safer and more effective dosing strategies for HIV/TB co-treatment in children.
CONDITIONS
Brief Title
Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ART-na�efve or ART-experienced HIV-infected children between 4 weeks and under 6 years of age
- Active TB diagnosis
- Weight of at least 3 kilograms
- Consent of the parent or legal guardian
You will not qualify if you...
- Baseline labs showing severe abnormalities in ALT, total bilirubin, absolute neutrophil count, platelets, or creatinine
- Suspected TB meningitis or acute respiratory distress or decompensation
- Taking medications that interact with dolutegravir or rifampicin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 48 weeks
Participants receive HIV/TB cotreatment with dolutegravir and rifampicin, including a 2-week period where rifampicin dose is increased to high-dose to assess pharmacokinetics and safety.
PK sampling at weeks 20, 22, and 30; blood sampling for biomarker assessment at 4 or 5 time points during the study
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here