NCT06281834RecruitingPhase 1
Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for 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 living with HIV, yet insufficient data are available on the pharmacokinetics of newer TB prevention strategies in children. Short-course TB prevention/latent TB infection (LTBI) treatment regimens increase completion rates but have not been adequately studied among children living with HIV. Our prospective, open-label PK study will examine and extend use of weekly rifapentine and isoniazid (3HP) among children receiving dolutegravir. This will address gaps in knowledge by examining two-way PK of short-course LTBI treatment in a vulnerable pediatric population.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 16 Feb 2024
- Start date
- 15 Nov 2024
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT06281834
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 25
- From 15 Nov 2024 to the primary completion date, 1 Feb 2027
- 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
- (3) receipt of a medication that has drug-drug interactions with DTG or RPT.
Other illness
- (2) presenting with acute respiratory distress or decompensation, or any clinical syndrome which could suggest undiagnosed TB or other opportunistic infection; or
Lab values
- (1) Baseline labs with evidence of ≥grade 3 abnormalities: alanine aminotransferase (ALT), total bilirubin, absolute neutrophil count (ANC), platelets, creatinine;
Who the study is looking for
- (1) ART-naïve or ART-experienced HIV-infected children 4 weeks to \<12 years of age;
- (2) no evidence of active TB based on an appropriate clinical evaluation;
- (3) negative TB diagnostic test if performed (other than tuberculin skin testing);
- (4) weight of at least 4 kilograms; and
- (5) consent of the parent or legal guardian and assent of the child (if ≥7 years of age).
Age in the registry: 4 weeks to 11 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 Coordinator of this site? Confirm its status | Ibadan | Nigeria | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.