NCT06532656

Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1

A Phase 2/3, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	Lenacapavir	Tablets administered orally without regard to food
DRUG	BIC/LEN FDC	Tablets administered orally without regard to food

Timeline

• Start date: 2024-11-20
• Primary completion: 2028-02-01
• Completion: 2028-08-01
• First posted: 2024-08-01
• Last updated: 2026-01-12

Locations

21 sites across 5 countries: United States, Argentina, Italy, South Africa, Spain

Regulatory

• FDA-regulated drug study