Actively Recruiting
Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention
Led by Brigham and Women's Hospital · Updated on 2024-12-24
25
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
A
APIN Public Health Initiatives
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the use of weekly rifapentine and isoniazid (3HP) as a short-course treatment to prevent tuberculosis (TB) in children living with HIV. This study focuses on how these drugs interact with dolutegravir, a common HIV medication, in children who do not have active TB. The goal is to understand drug levels and safety in two age groups: children under 2 years and those aged 2 to 11 years, addressing gaps in knowledge about this vulnerable population. Children aged 2 to 11 years will receive standard HIV treatment including dolutegravir once daily and weekly rifapentine/isoniazid for 12 weeks as recommended by the World Health Organization (WHO). Children under 2 years will receive standard dolutegravir-based HIV treatment plus daily isoniazid and a single dose of weekly rifapentine/isoniazid for study purposes. Blood samples will be taken to measure drug concentrations and biomarkers related to drug action. Participants will be monitored for 48 weeks, with intensive pharmacokinetic sampling at week 6 and additional sampling at weeks 4 and 7. Safety and toxicity will be assessed through clinical and laboratory tests during this period. Researchers will measure dolutegravir exposure during rifapentine/isoniazid treatment and monitor adverse events to better understand the treatment's effects in children living with HIV.
CONDITIONS
Brief Title
Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 4 weeks to under 12 years with HIV infection
- Children who are either ART-naive or ART-experienced
- No evidence of active tuberculosis based on clinical evaluation
- Negative TB diagnostic test if performed (other than tuberculin skin test)
- Weight of at least 4 kilograms
- Consent from parent or legal guardian and assent from child if 7 years or older
You will not qualify if you...
- Laboratory evidence of grade 3 or higher abnormalities in ALT, total bilirubin, ANC, platelets, or creatinine at baseline
- Presence of acute respiratory distress, decompensation, or clinical signs suggesting undiagnosed TB or other opportunistic infection
- Use of medications that interact with dolutegravir or rifapentine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks for children 2-11 years; variable for children under 2 years
Participants receive standard HIV treatment with dolutegravir and tuberculosis prevention treatment. Children aged 2-11 years receive weekly rifapentine/isoniazid (3HP) for 12 weeks. Children younger than 2 years receive a single dose of weekly rifapentine/isoniazid followed by daily isoniazid prophylaxis.
Weekly visits during rifapentine/isoniazid treatment and additional visits for blood sampling at weeks 4, 6, and 7
Duration - Up to 48 weeks
Participants undergo clinical and laboratory monitoring for safety and pharmacokinetics over 48 weeks, including blood sampling for drug levels and biomarker assessments.
Blood sampling at multiple time points up to week 48 with varying frequency depending on ART experience
Trial Site Locations
Total: 1 location
1
University College Hospital
Ibadan, Oyo State, Nigeria, Nigeria
Actively Recruiting
Research Team
H
Holly Rawizza, MD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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