Evaluating dolutegravir in children with HIV and TB receiving different doses of rifampicin
Mind the Gaps: Pharmacokinetic Research to Advance Pediatric HIV/TB Cotreatment and TB Prevention
This study is testing how safe and effective a medication called dolutegravir is for young children with both HIV and TB who are taking different doses of another medicine called rifampicin.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 4 Weeks to 5 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Ibadan, Oyo State) |
| Trial ID | NCT05069688 on ClinicalTrials.gov |
What this trial studies
This study investigates the pharmacokinetics and safety of dolutegravir in HIV/TB coinfected children aged 4 weeks to less than 6 years. It is a prospective, single-arm, open-label study that will recruit 20 children from pediatric HIV clinics in Nigeria, divided into two age cohorts. Participants will receive standard and high doses of rifampicin while undergoing routine clinical monitoring. Blood samples will be collected at various time points to assess drug concentrations and monitor for potential toxicity.
Who should consider this trial
Good fit: Ideal candidates are HIV-infected children aged 4 weeks to less than 6 years who are actively diagnosed with tuberculosis.
Not a fit: Patients with severe baseline lab abnormalities or those with suspected TB meningitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for HIV/TB coinfected children, potentially enhancing their health outcomes.
How similar studies have performed: While studies on pharmacokinetics in adult populations have shown promise, this specific approach in young children is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ibadan, Oyo State
- University College Hospital/ University of Ibadan — Ibadan, Oyo State, Nigeria (Recruiting)
Study contacts
- Principal investigator: Holly Rawizza, MD, MPH — Brigham and Women's Hospital
- Study coordinator: Holly Rawizza, MD, MPH
- Email: hrawizza@bwh.harvard.edu
- Phone: 617-432-4686
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.