Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)

Study acronym: ARTISTRY-1
StatusActive, Not Recruiting
PhasePhase 2/3
Started

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Trial flagged as At Risk
Primary endpoint reworded 2 of 2 changed
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Record History

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  1. Results posted: Oct 21, 2026 Show 9 more changesShow less
    • Primary endpoint(s) modified
    • Study completion pushed from Jul 2028 to Dec 2029
    • Trial arms changed: 5 → 6
    • Interventions: BIC/LEN FDC (Drug), Bictegravir (Drug), Lenacapavir (Drug), Stable Baseline Regimen (Drug) to BIC/LEN FDC (Drug), Bictegravir (Drug), Lenacapavir (Drug), Stable Baseline Regimen (Drug)
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: 17 to 20
    • Site details revised at 13 of 94 sites
    • Publications: 2 to 3
    • Study title expanded, about 1 word
  2. Secondary endpoints: 12 to 17v28
  3. Primary completion date changed from estimate of Sep 2025 to Sep 29, 2025v27
  4. Re-verified, no change to tracked fieldsv26
  5. Trial status: Recruiting to Active, Not Recruitingv25 Show 4 more changesShow less
    • Enrollment target: estimated 671 to confirmed 689
    • Primary completion date: Jan 2026 to Sep 2025
    • Study completion date: Nov 2028 to Jul 2028
    • Site details revised at 94 of 94 sites
Show 23 earlier versionsHide 23 earlier versions
  1. Study sites: 93 to 94v24
  2. Study sites: 92 to 93v23
  3. 2 versions Re-verified since Jul 9, 2024, no change to tracked fieldsv21-v22
  4. Study sites: 89 to 92v20
  5. Study sites: 87 to 89v19
  6. Study sites: 44 to 87v18
  7. Trial status: Active, Not Recruiting to Recruiting
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: 9 to 12
    • Site details revised at 44 of 44 sites
    v17
  8. 6 versions Re-verified since Feb 17, 2023, no change to tracked fieldsv11-v16
  9. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 44 of 44 sites
    v10
  10. Study sites: 43 to 44v9
  11. Study sites: 40 to 43v8
  12. Study sites: 38 to 40v7
  13. Study sites: 32 to 38v6
  14. Study sites: 28 to 32v5
  15. Study sites: 17 to 28v4
  16. Study sites: 4 to 17v3
  17. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    • Start date changed from estimate of Aug 2022 to Aug 16, 2022
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Gilead Sciences
115 trials monitored
See 14 trials at risk
The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC) plus lenacapavir (LEN), versus current therapy (Phase 2) and BIC/LEN fixed-dose combination (FDC) versus current therapy (Phase 3) in people living with HIV (PWH).
Trial Details
NCT Number NCT05502341
Lead Sponsor Gilead Sciences
Conditions
(from sponsor)		 HIV-1-infection
Enrollment 689 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov