Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Sep 26, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called dolutegravir works in children who have both HIV and tuberculosis (TB). Researchers want to find out if using a higher dose of another medication, rifampicin, can help dolutegravir work better and make treatment safer for these children. TB is a serious illness that can be particularly dangerous for kids with HIV, so understanding how these treatments interact is very important.

To participate in this study, children need to be between 4 weeks and under 6 years old, have an active TB diagnosis, and weigh at least 3 kilograms. Their parents or legal guardians must agree to their participation. Throughout the trial, participants will receive dolutegravir twice a day alongside either standard or high doses of rifampicin. The researchers will closely monitor their health to ensure safety and effectiveness. This study is a crucial step in improving treatment options for young children facing these two serious infections.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ART-naïve or ART-experienced HIV-infected children between 4 weeks and \<6 years of age
• • Active TB diagnosis
• • Weight of at least 3 kilograms
• • Consent of the parent or legal guardian
• Exclusion Criteria:
• • Baseline labs with evidence of ≥grade 3 abnormalities: ALT, total bilirubin, absolute neutrophil count (ANC), platelets, or creatinine
• • Suspected TB meningitis or presenting with acute respiratory distress or decompensation
• • Receipt of a medication that has drug-drug interactions with dolutegravir or rifampicin