Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin
Recruiting
Phase 1
Interventional Study
Pediatric HIV Infection
Tuberculosis Infection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 4 Weeks – 5
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Brigham and Women's Hospital · Other
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 dolut…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* Baseline labs with evidence of ≥grade 3 abnormalities: ALT, total bi…
Contacts