Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age4-11
SponsorBrigham and Women's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
(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
Disqualifiers
(1) Baseline labs with evidence of ≥grade 3 abnormalities: alanine aminotransferase (ALT), total bilirubin, absolute neutrophil count (ANC), platelets, creatinine;
(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.
Trial design
Treatments tested in this trial
- Rifapentine
- Dolutegravir
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Brigham and Women's Hospital
Lead sponsor
APIN Public Health Initiatives
Collaborator
University of Cape Town
Collaborator
Source ClinicalTrials.gov