NCT05069688RecruitingPhase 1
Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin
Mind the Gaps: Pharmacokinetic Research to Advance Pediatric HIV/TB Cotreatment and TB Prevention
Source: ClinicalTrials.gov · Last updated 30 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 16 Sept 2021
- Start date
- 7 Jul 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT05069688
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 7 Jul 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of a medication that has drug-drug interactions with dolutegravir or rifampicin
Lab values
- Baseline labs with evidence of ≥grade 3 abnormalities: ALT, total bilirubin, absolute neutrophil count (ANC), platelets, or creatinine
Other
- Suspected TB meningitis or presenting with acute respiratory distress or decompensation
Who the study is looking for
- 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
Age in the registry: 4 weeks to 5 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University College Hospital/ University of Ibadan Coordinator of this site? Confirm its status | Ibadan | Nigeria | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.