Clinical Trial

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy

Study acronym: ARTISTRY-2
Active, Not Recruiting Phase 3
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Summary
The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH). The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2024-03-20; most recent amendment 2026-06-11.
Status change: Recruiting → Active, Not Recruiting 2024-12-23
Status change: Not Yet Recruiting → Recruiting 2024-04-15
Trial Details
NCT Number NCT06333808
Lead Sponsor Gilead Sciences
Conditions HIV-1-infection
Enrollment 577 participants
Start Date 2024-03-25
Primary Completion 2025-10-27 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-15