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

StatusActive, Not Recruiting
PhasePhase 2/3
Started2024-11-20
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 43 months later Nov 2026 → Jul 2030
See other at-risk trials from Gilead Sciences

Amendment history

2026-09-30
Primary completion pushed: 2026-11 → 2030-07
2026-09-29
Primary completion moved earlier: 2030-07 → 2026-11
Interventions modified
2026-06-03
Study Status, Contacts/Locations v13
Trial status changed: Recruiting → Active, Not Recruiting
Primary completion pushed: 2028-02 → 2030-07
Completion pushed: 2028-08 → 2030-12
Study sitesdetails revised at 21 of 21 sites
2026-01-09
Study Status, Contacts/Locations v12
Study sites20→21
2025-10-28
Study Status, Contacts/Locations v11
Study sites19→20
Show 10 earlier versions
2025-10-13
Study Status, Contacts/Locations v10
Study sites18→19
2025-09-18
Study Status, Contacts/Locations v9
Study sitesdetails revised at 1 of 18 sites
2025-08-28
Study Status, Contacts/Locations v8
Study sites17→18
2025-06-20
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 17 sites
2025-03-21
Study Status, Outcome Measures, Contacts/Locations v6
Study sites15→17
2025-01-31
Study Status, Contacts/Locations v5
Study sites11→15
2025-01-07
Study Status, Contacts/Locations v4
Study sites9→11
2024-12-12
Study Status, Contacts/Locations v3
Start dateestimated 2024-11→confirmed 2024-11-20
Study sites1→9
2024-10-25
Study Status v2
Start date2024-09→2024-11
2024-09-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations, References v1
Trial statusNot Yet Recruiting→Recruiting
Start date2024-08→2024-09
Study sites0→1
2024-07-29
Original filing
Gilead Sciences
107 trials monitored
See 8 trials at risk
The goal of this clinical study is to learn about the safety and tolerability of bictegravir (BIC)/lenacapavir (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.
Trial Details
NCT Number NCT06532656
Lead Sponsor Gilead Sciences
Conditions HIV-1-infection
Enrollment 75 participants
Start Date 2024-11-20
Primary Completion 2030-07 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-29