Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1
NCT Number: NCT06532656
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: HIV-1-infection
Interventions: DRUG: Lenacapavir|DRUG: BIC/LEN FDC
Sponsor: Gilead Sciences
Sex: ALL
Age: CHILD
Enrollment: 75
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2028-08

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.

Primary Outcome Measures: PK Parameter: Cmax of BIC and LEN at Steady State, Cmax is defined as the maximum observed concentration of drug at steady state., Day 1 up to Week 48, as appropriate|PK Parameter: AUCtau of BIC and LEN at Steady State, AUCtau is defined as the area under the concentration versus time curve over the dosing interval at steady state., Day 1 up to Week 48, as appropriate|PK Parameter: Ctrough of BIC and LEN at Steady State, Ctrough is defined as the observed drug concentration at the end of the dosing interval at steady state., Day 1 up to Week 48, as appropriate|Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) Through Week 24, First dose date up to Week 24|Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 24, First dose date up to Week 24
Secondary Outcome Measures: PK Parameter: AUClast for BIC and LEN at Steady State, AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration at steady state., Day 1 up to Week 48, as appropriate|PK Parameter: Tmax for BIC and LEN at Steady State, Tmax is defined as the time (observed time point) of Cmax at steady state., Day 1 up to Week 48, as appropriate|PK Parameter: Tlast for BIC and LEN at Steady State, Tlast is defined as the time (observed time point) of Clast at steady state. Clast is defined as the last measurable concentration (above the quantification limit)., Day 1 up to Week 48, as appropriate|PK Parameter: T1/2 for BIC and LEN at Steady State, T1/2 is defined as the terminal elimination half-life at steady state., Day 1 up to Week 48, as appropriate|PK Parameter: CL for BIC and LEN at Steady State, Clearance (CL) is the volume of plasma cleared of drug over a specified time period, at a steady state., Day 1 up to Week 48, as appropriate|PK Parameter: Vz for BIC and LEN at Steady State, Volume of distribution (Vz) is defined as the extent to in which the drug is distributed in the body tissue, rather than the plasma, to produce the desired effects at a steady state., Day 1 up to Week 48, as appropriate|PK Parameter: λz for BIC and LEN at Steady State, λz is defined as the terminal elimination rate constant, which determines the rate at which the drug will be eliminated from the body after it is absorbed and distributed at a steady state., Day 1 up to Week 48, as appropriate|Percentage of Participants Experiencing TEAEs Through Week 48, First dose date up to Week 48|Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 48, First does date up to Week 48|Proportion of Participants With Plasma HIV-1 RNA < 50 copies/mL and ≥ 50 copies/mL at Week 24 Based on the United States (US) Food and Drug Administration (FDA)-Defined Snapshot Algorithm, Week 24|Proportion of Participants With Plasma HIV-1 RNA < 50 copies/mL and ≥ 50 copies/mL at Week 48 Based on the United States FDA-Defined Snapshot Algorithm, Week 48|Change from Baseline in Clusters of Differentiation 4 (CD4) Cell Counts at Week 24, Baseline, Week 24|Change from Baseline in CD4 Percentage at Week 24, Baseline, Week 24|Change from Baseline in CD4 Cell Counts at Week 48, Baseline, Week 48|Change from Baseline in CD4 Percentage at Week 48, Baseline, Week 48|Acceptability and Palatability Summary of LEN Oral Loading Dose at Day 1 Assessed by Questionnaire, Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability., Day 1|Acceptability and Palatability Summary of LEN Oral Loading Dose at Day 2 Assessed by Questionnaire, Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability., Day 2|Acceptability and Palatability Summary of Oral BIC/LEN Fixed Dose Combination (FDC) at Day 1 Assessed by Questionnaire, Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability., Day 1|Acceptability and Palatability Summary of Oral BIC/LEN FDC at Week 4 Assessed by Questionnaire, Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability., Week 4|Acceptability and Palatability Summary of Oral BIC/LEN FDC at Week 24 Assessed by Questionnaire, Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability., Week 24|Acceptability and Palatability Summary of Oral BIC/LEN FDC at Week 48 Assessed by Questionnaire, Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability., Week 48