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

Study acronym: ARTISTRY-2
StatusActive, Not Recruiting
PhasePhase 3
Started2024-03-25
View on ClinicalTrials.gov ↗

Amendment history

2026-06-11
Study Status, Outcome Measures v11
Secondary endpoints7 entries, revised
Treatment Group 1: Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 and Week 144 as Determined by the US FDA-defined Snapshot Algorithm Treat [...] on of Participants with HIV-1 RNA < 50 copies/mL at Week 96 and Week 144 as Determined by US FDA-defined Snapshot Algorithm Treatment Group 1: Change from Baseline in CD4 Cell Count at Week 96 and Week 144 Treatment Group 1: Percentage of Participants Experiencing Treatment-Emergent AEs through Week 96 and Week 144
2025-11-03
Study Status v10
Primary completion dateestimated 2025-12→confirmed 2025-10-27
2024-12-23
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v9
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 546→confirmed 577
Study sitesdetails revised at 104 of 104 sites
2024-11-11
Study Status, Contacts/Locations v8
Study sites89→104
2024-10-14
Study Status, Contacts/Locations v7
Study sites76→89
Show 6 earlier versions
2024-09-16
Study Identification, Study Status, Contacts/Locations v6
Study sites68→76
2024-08-19
Study Status, Contacts/Locations v5
Study sites58→68
2024-07-25
Study Status, Contacts/Locations v4
Study sites45→58
2024-06-18
Study Status, Contacts/Locations v3
Study sites33→45
2024-05-15
Study Status, Contacts/Locations v2
Study sites7→33
2024-04-15
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations, References v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-03→confirmed 2024-03-25
Study sites0→7
2024-03-20
Original filing
Gilead Sciences
107 trials monitored
See 8 trials at risk
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.
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