NCT06532656

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

Active, enrolled Phase 2/Phase 3 Last updated 3 June 2026

What this trial tests

Phase 2/Phase 3 trial testing Lenacapavir in HIV-1-infection in 75 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

20 November 2024

Primary endpoint
1 July 2030

1 December 2030

Quick facts

Lead sponsor	Gilead Sciences
Phase	Phase 2/Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	75
Start date	20 November 2024
Primary completion	1 July 2030
Estimated completion	1 December 2030
Sites	21 locations across United States, Argentina, Italy, South Africa, Spain

Drugs / interventions tested

• Lenacapavir (LENACAPAVIR) — full drug profile →
• BIC/LEN FDC — full drug profile →

Conditions studied

• HIV-1-infection — all drugs for HIV-1-infection →

Sponsor

Gilead Sciences — full company profile →

Who can join

Adults 2 to 17, any sex, with HIV-1-infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• PK Parameter: Cmax of BIC and LEN at Steady State
  Time frame: Day 1 up to Week 24, as appropriate
  Cmax is defined as the maximum observed concentration of drug at steady state.
• PK Parameter: AUCtau of BIC and LEN at Steady State
  Time frame: Day 1 up to Week 24, as appropriate
  AUCtau is defined as the area under the concentration versus time curve over the dosing interval at steady state.
• PK Parameter: Ctrough of BIC and LEN at Steady State
  Time frame: Day 1 up to Week 24, as appropriate
  Ctrough is defined as the observed drug concentration at the end of the dosing interval at steady state.
• Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) Through Week 24
  Time frame: First dose date up to Week 24
• Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 24
  Time frame: First dose date up to Week 24

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Optimising Paediatric HIV Treatment: Recent Developments and Future Directions.
   Kamphuis AEM, Bamford A, Tagarro A, Cressey TR, et al · · 2024 · cited 3× · PMID 39436531 · DOI 10.1007/s40272-024-00656-4