The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age

Summary

Participation Requirements

Description

This study will examine the pharmacokinetics (PK), safety, and tolerability of fixed-dose combination abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) dispersible and immediate release tablets in HIV-1-infected children less than 12 years of age. Children will be enrolled into one of five ABC/DTG/...

This study will examine the pharmacokinetics (PK), safety, and tolerability of fixed-dose combination abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) dispersible and immediate release tablets in HIV-1-infected children less than 12 years of age. Children will be enrolled into one of five ABC/DTG/3TC dosing groups based on their weight. The first 5-7 children within each weight-band will undergo intensive PK assessments 5-10 days after starting ABC/DTG/3TC to confirm dose selection. Children will remain on their initial dose of ABC/DTG/3TC through Week 4. After Week 4, ABC/DTG/3TC dosing will be adjusted based on PK results at the individual or weight-band level, and/or an individual child's growth and weight gain over time. Follow-up study visits for all participants will occur at Weeks 1, 4, 12, 24, 36, and 48. Some participants may attend additional study visits at Weeks 2, 6, 8, 16, and/or 20. Study visits may include physical examination, study drug adherence and tolerability questionnaires, blood collection, and intensive PK sampling. Following the Week 48 study visit, some children may continue on the study for up to 144 weeks.

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