Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention
NCT ID: NCT06281834
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
25 participants
INTERVENTIONAL
2024-11-15
2027-06-30
Brief Summary
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Detailed Description
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Children will be recruited from two large pediatric HIV clinics in Nigeria. Children 2-11 years will receive HIV treatment that is considered standard of care consisting of weight-based DTG once daily along with two non-nucleoside reverse transcriptase inhibitors (NRTIs), plus 3HP at standard doses for LTBI treatment. Children \<2 years of age also receive standard DTG-based ART as well as standard isoniazid (INH) prophylaxis for LTBI, however, they will additionally receive a single dose of weekly RPT/INH for study purposes. The primary study intervention is, therefore, additional blood sampling for drug concentration determination (both DTG and RPT) and biomarker assessment. Clinical and laboratory monitoring for toxicity occur throughout the 48 week study period.
PK sampling for drug concentration determination will occur at three time points during the 48-week study. Specifically, intensive PK sampling will occur at study week 6, while sparse PK sampling will occur at weeks 4 and 7. Additionally, the endogenous biomarker of CYP3A4 activity, 4-beta-hydroxycholesterol to cholesterol ratio, will be evaluated to advance understanding of underlying mechanisms of drug action. Blood sampling to quantify this biomarker will occur at either 4 (among ART-experienced children) or 5 (ART-naive) time points during the 48-week study.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dolutegravir PK during weekly rifapentine/isoniazid for TB prevention
This is a single arm study: all patients are started on standard HIV treatment, with LTBI/TB prevention treatment varying according to age cohorts. Children 2-11 years receive standard weekly rifapentine/isoniazid (3HP) for TB prevention; those \<2 years received a single-dose of extrapolated weekly RPT/INH, followed by standard INH prophylaxis.
Rifapentine
Children 2-11 years received standard HIV treatment and 3HP (RPT/INH weekly for 12 weeks) for TB prevention. Children \<2 years receive standard HIV treatment, a single-dose of extrapolated weekly RPT/INH, followed by standard INH prophylaxis. Safety and pharmacokinetics will be evaluated.
Dolutegravir
All children in this study are living with HIV and thus dolutegravir is a standard part of treatment; in this study we will collect blood samples to measure dolutegravir levels during combination treatment with rifapentine/isoniazid treatment for TB prevention
Interventions
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Rifapentine
Children 2-11 years received standard HIV treatment and 3HP (RPT/INH weekly for 12 weeks) for TB prevention. Children \<2 years receive standard HIV treatment, a single-dose of extrapolated weekly RPT/INH, followed by standard INH prophylaxis. Safety and pharmacokinetics will be evaluated.
Dolutegravir
All children in this study are living with HIV and thus dolutegravir is a standard part of treatment; in this study we will collect blood samples to measure dolutegravir levels during combination treatment with rifapentine/isoniazid treatment for TB prevention
Eligibility Criteria
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Inclusion Criteria
* (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).
Exclusion Criteria
* (2) presenting with acute respiratory distress or decompensation, or any clinical syndrome which could suggest undiagnosed TB or other opportunistic infection; or
* (3) receipt of a medication that has drug-drug interactions with DTG or RPT.
4 Weeks
11 Years
ALL
No
Sponsors
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APIN Public Health Initiatives
UNKNOWN
University of Cape Town
OTHER
Brigham and Women's Hospital
OTHER
Responsible Party
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Holly Rawizza, M.D., M.P.H.
Assistant Professor of Medicine
Principal Investigators
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Holly Rawizza, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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University College Hospital
Ibadan, Oyo State, Nigeria
Countries
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Central Contacts
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Facility Contacts
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Regina Oladokun, MD
Role: primary
Other Identifiers
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2024P000306
Identifier Type: -
Identifier Source: org_study_id