NCT05069688 Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin
| NCT ID | NCT05069688 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Brigham and Women's Hospital |
| Condition | Pediatric HIV Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-07-07 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2023-07-07 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 bilirubin, absolute neutrophil count (ANC), platelets, or creatinine * Suspected TB meningitis or presenting with acute respiratory distress or decompensation * Receipt of a medication that has drug-drug interactions with dolutegravir or rifampicin
Contact & Investigator
Holly Rawizza, MD, MPH
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT05069688 clinical trial?
This trial is open to participants of all sexes, aged 4 Weeks or older, up to 5 Years, studying Pediatric HIV Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05069688 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05069688 currently recruiting?
Yes, NCT05069688 is actively recruiting participants. Contact the research team at hrawizza@bwh.harvard.edu for enrollment information.
Where is the NCT05069688 trial being conducted?
This trial is being conducted at Ibadan, Nigeria.
Who is sponsoring the NCT05069688 clinical trial?
NCT05069688 is sponsored by Brigham and Women's Hospital. The principal investigator is Holly Rawizza, MD, MPH at Brigham and Women's Hospital. The trial plans to enroll 20 participants.
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