Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1
Trial Parameters
Brief Summary
The goal of this clinical study is to learn about the safety and tolerability of bictegravir/lenacapavir (BIC/LEN) and to learn how the study drug interacts with the body in virologically suppressed (VS) children and adolescents with human immunodeficiency virus type 1 (HIV-1) on a stable and complex antiretroviral (ARV) regimen. The study will also assess the safe loading dose of LEN and pharmacokinetics (PK) of BIC/LEN. The primary objectives of this study are: * To evaluate the steady-state PK of BIC and LEN and confirm the dose of the LEN loading dose and BIC/LEN FDC in VS children and adolescents with HIV-1. * To evaluate the safety and tolerability of BIC/LEN through Week 24 in VS children and adolescents with HIV-1.
Eligibility Criteria
Key Inclusion Criteria: * Age and body weight at screening: * Cohort 1: ≥ 12 years to \< 18 years weighing ≥ 35 kg. * Cohort 2: ≥ 6 years to \< 12 years weighing ≥ 25 kg to \< 35 kg. * Cohort 3: ≥ 2 years to \< 6 years weighing ≥ 10 kg to \< 25 kg. * On a complex ARV regimen. Complex regimens are any ARV therapy that is not a single-tablet regimen taken once daily (eg, \> 1 tablet or any other formulation a day). * Documented plasma HIV-1 ribonucleic acid (RNA) levels must be \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is \< 50 copies/mL) in the last 6 months prior to screening (at least 1 measure prior to screening). * Plasma HIV-1 RNA levels \< 50 copies/mL at screening. * No documented or suspected resistance to integrase strand transfer inhibitors (mutations T66A/I/K, E92G/Q/V, G118R, F121C/Y, G140R, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene). * The following laboratory parameters at s