Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Feb 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well the medications dolutegravir, rifapentine, and isoniazid work together in children who are living with HIV and have latent tuberculosis (TB) infection. Latent TB means that the bacteria are present in the body but are not causing any illness. The trial aims to gather important information about how these medications are processed in the body when given to children, especially since there is limited research on TB prevention strategies for kids with HIV.

To participate in this study, children aged 4 weeks to under 12 years who have HIV but no active TB may be eligible, provided they weigh at least 4 kilograms. Parents or guardians must give consent, and children aged 7 years or older will also need to agree to participate. During the trial, participants will receive the combination of medications, and researchers will closely monitor them to ensure safety and gather data. This study is important because it seeks to improve TB prevention strategies specifically for vulnerable children with HIV, helping to reduce the risk of TB, which is a leading cause of death in this population.

Gender

ALL

Eligibility criteria

• 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.