NCT06333808|Active Not RecruitingPhase 3DMCFDA Drug

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

ARTISTRY-2

Phase 3 Double-blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Biktarvy® (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1

Gilead Sciences ClinicalTrials.gov

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3 other identifiers

GS-US-621-62902023-510022-33jRCT2051240046

Study Type

interventional

Target

577

Locations

14 countries

Sites

104

Timeline

RegisteredMar 2024

StartedMar 2024

CompletionDec 2029

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

577

participants targeted

Target at P75+ for phase_3

Timeline

43mo left

Started Mar 2024

Longer than P75 for phase_3

Geographic Reach

14 countries

104 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.7 years study duration

Study Progress37%

Mar 2024Dec 2029

First Submitted

Initial submission to the registry

March 20, 2024

Completed

5 days until next milestone

Study Start

First participant enrolled

March 25, 2024

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2025

Completed

4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Expected

Last Updated

November 5, 2025

Status Verified

November 1, 2025

Enrollment Period

1.6 years

First QC Date

March 20, 2024

Last Update Submit

November 3, 2025

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
Week 48

Secondary Outcomes (7)

Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
Week 48
Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 48
Baseline; Week 48
Treatment Group 1: Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm
Week 96
Treatment Group 1: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 96 as Determined by US FDA-defined Snapshot Algorithm
Week 96
Treatment Group 1: Change from Baseline in CD4 Cell Count at Week 96
Baseline; Week 96
+2 more secondary outcomes

Study Arms (2)

Treatment Group 1: Bictegravir (BIC)/ Lenacapavir (LEN) (75/50 mg) + PTM B/F/TAF

EXPERIMENTAL

Blinded Phase: Participants will switch from bictegravir/emtricitabine/tenofovir (B/F/TAF) FDC tablets to BIC/LEN (75/50 mg) FDC tablets and placebo-to-match (PTM) B/F/TAF. Participants will receive a 2-day oral loading dose of LEN 600 mg on Day 1 and on Day 2, in addition to the daily doses of BIC/LEN FDC tablet starting on Day 1 up to end of blinded treatment (EBT) visit. Open-label (OL) Phase: Following treatment in the Blinded Phase, participants from Treatment Group 1 will receive BIC/LEN FDC tablets through Week 48 in the Open-label Phase. At the OL Week 48 visit, participants from Treatment Group 1 will be given the option to continue to receive BIC/LEN FDC tablets until the conclusion of the OL Phase.

Drug: BictegravirDrug: LenacapavirDrug: Placebo to match B/F/TAF

Treatment Group 2: B/F/TAF (50/200/25 mg) + PTM BIC/LEN

EXPERIMENTAL

Blinded Phase: Participants will continue with their B/F/TAF (50/200/25 mg) FDC tablets and start PTM BIC/LEN tablets on Day 1. Participants will receive PTM LEN tablets for 2 days (2 PTM LEN tablets on Day 1 and on Day 2. The blinded phase will continue until the EBT visit. Open Label Phase: Participants in Treatment Group 2 who complete the EBT visit will be given the option to enter the OL phase to receive BIC/LEN FDC tablets until the conclusion of the OL Phase.

Drug: BictegravirDrug: LenacapavirDrug: B/F/TAFDrug: Placebo to match BIC/LEN