Mind the Gaps: Pharmacokinetic Research to Advance Pediatric HIV/TB Cotreatment and TB Prevention

Who is this study for? Children coinfected with HIV/Tuberculosis
What treatments are being studied? Rifampicin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 28 days
Maximum Age: 5
Healthy Volunteers: f
View:

• ART-naïve or ART-experienced HIV-infected children between 4 weeks and \<6 years of age

• Active TB diagnosis

• Weight of at least 3 kilograms

• Consent of the parent or legal guardian

Locations
Other Locations
Nigeria
University College Hospital/ University of Ibadan
RECRUITING
Ibadan
Contact Information
Primary
Holly Rawizza, MD, MPH
hrawizza@bwh.harvard.edu
617-432-4686
Time Frame
Start Date: 2023-07-07
Estimated Completion Date: 2025-03-31
Participants
Target number of participants: 20
Treatments
Experimental: Dolutegravir PK during standard and high-dose rifampicin
This is a single arm study: all patients are started on HIV/TB cotreatment considered standard of care and then for two weeks (study weeks 20-21) high-dose rifampicin is given during which safety and pharmacokinetics are examined.
Related Therapeutic Areas
HIV/AIDS
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: APIN Public Health Initiatives, University of Cape Town

This content was sourced from clinicaltrials.gov

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