Tests dolutegravir levels in young children with HIV and tuberculosis
Tests how dolutegravir is processed when given with standard or high-dose rifampicin in young children.
Key facts
- Who runs it
- Brigham and Women's Hospital
- Where
- Ibadan, NigeriaSee the site
- Trial code
- Registry title
- Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 20 people, planned
- Started
- 7 Jul 2023
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional
- Treatments tested
- rifampicin
- Record updated
- 30 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for young children with HIV and active TB. They get dolutegravir with standard and then high-dose rifampicin.
- Age
- From 4 weeks to under 6 years old
- Sex
- Girls and boys can both join
- Disease stage
- HIV infection with an active TB diagnosis
- Earlier treatment
- Children can be new to HIV treatment (ART) or already on it
Main reasons for not taking part
- Lab results with grade 3 or worse abnormalities (ALT, total bilirubin, neutrophils, platelets or creatinine)
- Suspected TB meningitis
- Acute breathing distress or sudden worsening of the child's condition
- Taking a medicine that interacts with dolutegravir or rifampicin
This trial only enrols participants living with HIV. The registry sentence this rests on: ART-naïve or ART-experienced HIV-infected children between 4 weeks and <6 years of age
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- Receipt of a medication that has drug-drug interactions with dolutegravir or rifampicin
- Baseline labs with evidence of ≥grade 3 abnormalities: ALT, total bilirubin, absolute neutrophil count (ANC), platelets, or creatinine
- Suspected TB meningitis or presenting with acute respiratory distress or decompensation
Where in Nigeria
- University College Hospital/ University of IbadanIbadan, NigeriaContact: Regina Oladokun, MDTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Dolutegravir PK during standard and high-dose rifampicinTreatment being tested
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.
Treatment: rifampicin
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Mind the Gaps: Pharmacokinetic Research to Advance Pediatric HIV/TB Cotreatment and TB Prevention
- Plain-language title
- Tests dolutegravir levels in young children with HIV and tuberculosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 30 July 2026