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RECRUITINGPhase 1INTERVENTIONAL

Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - (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). Who Should NOT Join This Trial: - (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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * (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). Exclusion Criteria: * (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.

Treatments Being Tested

DRUG

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.

DRUG

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

Locations (1)

University College Hospital
Ibadan, Oyo State, Nigeria