Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy (ARTISTRY-2)

November 3, 2025 updated by: Gilead Sciences

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

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.

Study Overview

Status

Active, not recruiting

Conditions

HIV-1-infection

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

577

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, C1202ABB
    - Fundación Huésped
  - Buenos Aires, Argentina, C1141ACG
    - Helios Salud S.A.
  - Santa Fe, Argentina, S2000PBJ,
    - Instituto CAICI SRL
Australia
- New South Wales
  - Darlinghurst, New South Wales, Australia, 2011
    - Taylor Square Private Clinic
- Victoria
  - Melbourne, Victoria, Australia, 3004
    - Alfred Hospital(Alfred Health)
  - South Yarra, Victoria, Australia, 3141
    - Prahran Market Clinic
Canada
- - Decarie Montreal, Canada, H4A 3J1
    - Chronic Viral Illness Service/McGill University Health Centre (MUHC)
  - Montreal, Canada, H2L 4P9
    - Clinique Médicale L'Actuel
  - Ottawa, Canada, K1H 8L6
    - The Ottawa Hospital - General Campus
  - Regina, Canada, S4P 0W5
    - Regina General Hospital
  - Vancouver, Canada, V6Z1Y6
    - St. Paul's Hospital, John Ruedy Clinic-Immunodeficiency Clinic (JRC-IDC)
  - Victoria, Canada, V8W 1M8
    - Cool Aid Community Health Centre
Dominican Republic
- - Santo Domingo, Dominican Republic
    - Instituto Dominicano de Estudios Virologicos - IDEV
Germany
- - Aachen, Germany, 52062
    - Praxis Dr. Knechten
  - Berlin, Germany, 10117
    - Novopraxis Berlin
  - Cologne, Germany, 50668
    - Praxis am Ebertplatz
  - Frankfurt, Germany, 60590
    - Universitatsklinikum Frankfurt
  - Hamburg, Germany, 20246
    - Universitatsklinikum Hamburg Eppendorf
  - Munich, Germany, 80336
    - LMU Klinikum der Universität
  - München, Germany, 81675
    - Klinikum rechts der Isar der Technischen Universitaet Muenchen
Italy
- - Brescia, Italy, 25123
    - ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
  - Foggia, Italy, 71122
    - Azienda Ospedaliero Universitaria Ospedali Riuniti (Policlinico di Foggia)
  - Milan, Italy, 20127
    - IRCCS Ospedale San Raffaele
  - Monza, Italy, 20090
    - Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo
  - Pavia, Italy, 27100
    - Fondazione IRCCS Policlinico San Matteo di Pavia
  - Roma, Italy, 00168
    - Fondazione Policlinico Universitario A Gemelli-Rome
  - Roma, Italy, 00149
    - Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
Japan
- - Aichi, Japan, 460-0001
    - National Hospital Organization Nagoya Medical Center
  - Osaka, Japan, 540-0006
    - National Hospital Organization Osaka National Hospital
  - Tokyo, Japan, 162-0052
    - Center Hospital of the National Center for Global Health and Medicine
Mexico
- - Mexico City, Mexico, 6170
    - ProcliniQ Investigacion Clinica Toriello Guerra, Tlalpan
  - Mérida, Mexico, 97070
    - Unidad de Atención Médica e Investigación en Salud
Puerto Rico
- PR
  - San Juan, PR, Puerto Rico, 00909
    - HOPE Clinical Research
  - San Juan, PR, Puerto Rico, 00935
    - Proyecto ACTU
South Korea
- - Daegu, South Korea, 41944
    - Kyungpook National University Hospital
  - Seoul, South Korea, 03722
    - Severance Hospital, Yonsei University Health System
  - Seoul, South Korea, *04564
    - National medical center
  - Seoul, South Korea, 137-701
    - The Catholic University of Korea, Seoul St. Mary's Hospital
Spain
- - Badalona Barcelona, Spain, 8916
    - Hospital Universitario Germans Trias i Pujol
  - Barcelona, Spain, 08036
    - Hospital Clinic de Barcelona
  - Madrid, Spain, 28034
    - Hospital Universitario Ramon y Cajal
  - Madrid, Spain, 28046
    - Hospital Universitario La Paz - PPDS
  - Seville, Spain, 4103
    - Hospital Universitario Virgen del Rocio - PPDS
  - Valencia, Spain, 46014
    - Consorcio Hospital General Universitario de Valencia
Taiwan
- - Kaohsiung City, Taiwan, 81362
    - Kaohsiung Veterans General Hospital
  - Kaohsiung City, Taiwan, 80756
    - Kaohsiung Medical University Chung-Ho Memorial Hospital
  - Taipei, Taiwan, 100
    - National Taiwan University Hospital
  - Taoyuan, Taiwan, 33004
    - Taoyuan General Hospital, Ministry of Health and Welfare
United Kingdom
- - Liverpool, United Kingdom, L7 8XP
    - Liverpool University Hospitals NHS Foundation Trust, Royal Liverpool Hospital
  - London, United Kingdom, WC1E 6JB
    - Mortimer Market Centre
  - London, United Kingdom, SE5 9RS
    - King's College Hospital, Weston Education Centre
  - London, United Kingdom, SW109NH
    - Chelsea and Westminster Hospital NHS Foundation Trust, St Stephen's Centre, Chelsea and Westminster Hospital
  - London, United Kingdom, W2 1NY
    - St Mary's Hospital - PPDS
United States
- Arizona
  - Phoenix, Arizona, United States, 85015
    - Pueblo Family Physicians
- California
  - Berkeley, California, United States, 48072
    - Be Well Medical Center
  - Beverly Hills, California, United States, 90211
    - Pacific Oaks Medical Group
  - Los Angeles, California, United States, 90036
    - Ruane Clinical Research Group Inc.
  - Oakland, California, United States, 94609
    - Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care
  - Palm Springs, California, United States, 92262
    - BIOS Clinical Research
  - San Diego, California, United States, 92103
    - UCSD Anti Viral Research Centre (AVRC)
  - Torrance, California, United States, 90502
    - Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  - West Hollywood, California, United States, 90046
    - Mills Clinical Research
- Colorado
  - Denver, Colorado, United States, 80204
    - Public Health Institute at Denver Health
- Connecticut
  - New Haven, Connecticut, United States, 06510
    - Yale University School of Medicine (study visits)
- Florida
  - DeLand, Florida, United States, 32720
    - Midland Florida Infectious Diseases Specialists, PL - Orange City
  - Fort Lauderdale, Florida, United States, 33308
    - Therafirst Medical Center
  - Fort Lauderdale, Florida, United States, 33316
    - CAN Community Health
  - Ft. Pierce, Florida, United States, 34982
    - Midway Immunology and Research Center
  - Miami, Florida, United States, 33136
    - Schiff Center for Liver Diseases/University of Miami
  - Miami, Florida, United States, 33133
    - AIDS Healthcare Foundation - The Kinder Medical Group
  - Miami Lakes, Florida, United States, 33016
    - Floridian Clinical Research
  - Orlando, Florida, United States, 32803
    - Orlando Immunology Center
  - Orlando, Florida, United States, 32806
    - Bliss Healthcare
  - Pensacola, Florida, United States, 32503
    - AHF Pensacola
  - Sarasota, Florida, United States, 34237
    - CAN Community Health
  - West Palm Beach, Florida, United States, 33407
    - Triple O Research Institute, P.A.
- Georgia
  - Decatur, Georgia, United States, 30033
    - Infectious Disease Specialists of Atlanta
  - Macon, Georgia, United States, 31201
    - Mercer University, Department of Internal Medicine
- Massachusetts
  - Springfield, Massachusetts, United States, 01105
    - Claudia T Martorell MD LLC dba The Research Institute
- Michigan
  - Detroit, Michigan, United States, 48202
    - Henry Ford Health
- Missouri
  - Kansas City, Missouri, United States, 64111
    - KC Care Health Center
  - St Louis, Missouri, United States, 63139
    - Southampton Community Healthcare, Inc.
- New Jersey
  - Hillsborough, New Jersey, United States, 08844
    - ID Care, LLC
  - Newark, New Jersey, United States, 07102
    - Saint Michael's Medical Center
  - Newark, New Jersey, United States, 07103
    - New Jersey Medical School - Clinical Research Center
  - Somers Point, New Jersey, United States, 08244
    - South Jersey Infectious Disease
- New Mexico
  - Santa Fe, New Mexico, United States, 87505
    - AXCES Research Group, LLC
- New York
  - Flushing, New York, United States, 11355
    - New York-Presbyterian Queens
  - The Bronx, New York, United States, 10467
    - Montefiore Medical Center
- North Carolina
  - Greenville, North Carolina, United States, 27858
    - The Brody School of Medicine at East Carolina University , ECU Adult Specialty Care
  - Huntersville, North Carolina, United States, 28078
    - Rosedale Health and Wellness
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19107
    - Philadelphia FIGHT Community Health Centers
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina (MUSC) Research Nexus
- Texas
  - Austin, Texas, United States, 78705
    - Central Texas Clinical Research
  - Bellaire, Texas, United States, 77401
    - St Hope Foundation, Inc.
  - Dallas, Texas, United States, 75208
    - AIDS Arms, Inc. DBA Prism Health North Texas
  - Dallas, Texas, United States, 75246
    - North Texas Infectious Diseases Consultants, PA
  - El Paso, Texas, United States, 79902
    - AXCES Research Group, LLC
  - Fort Worth, Texas, United States, 76104
    - Texas Centers for Infectious Disease Associates
  - Houston, Texas, United States, 77098
    - The Crofoot Research Center, INC.
- Utah
  - Salt Lake City, Utah, United States, 84102
    - AXCES Research Group, LLC
- Virginia
  - Annandale, Virginia, United States, 22003
    - Clinical Alliance For Research & Education - Infectious Diseases. LLC (CARE-ID)
- Washington
  - Seattle, Washington, United States, 98104
    - Peter Shalit MD
  - Tacoma, Washington, United States, 98405
    - Community Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Key Inclusion Criteria:

Currently receiving B/F/TAF for at least 6 months prior to screening.
If plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) measurements in the last 6 months prior to screening are available, all levels must be < 50 copies/mL.
At least one documented HIV-1 RNA level measured between 6 and 12 months (± 2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be < 50 copies/mL.
Plasma HIV-1 RNA levels < 50 copies/mL at screening.
No documented or suspected resistance to BIC (including integrase strand-transfer inhibitor resistant (INSTI-R) mutations T66A/I/K, E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene).
No documented or suspected resistance to tenofovir alafenamide (TAF) (TAF; mutations K65R, K65N, K70E, Q151M or T69 insertion, or ≥ 3 of the following thymidine analog mutations [M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R] in the reverse transcriptase gene).
Estimated glomerular filtration rate ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance.

Key Exclusion Criteria:

Positive serum pregnancy test or pregnant at screening or a positive pregnancy test prior to Day 1 randomization.
Breastfeeding (nursing).
Prior use of, or exposure to, LEN.
Active, serious infections (other than HIV-1) requiring parenteral therapy < 30 days prior to randomization.
Active tuberculosis infection.
Acute hepatitis < 30 days before randomization.
Chronic hepatitis B virus (HBV) infection, as determined by either:
- Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit.
- Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit.
Known hypersensitivity to the study drug, its metabolites, or any formulation excipient.
History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as determined by the investigator.
Active malignancy requiring acute systemic therapy.
Any of the following laboratory values at screening:
- Alanine aminotransferase > 5 × upper limit of normal (ULN).
- Direct bilirubin > 1.5 × ULN.
- Platelets < 50,000/mm^3.
- Hemoglobin < 8.0 g/dL.
Requirement for ongoing therapy with or prior use of any prohibited medications listed in the protocol.
Participation or planned participation in any other clinical study (including observational studies) without prior approval from the sponsor.
Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group 1: Bictegravir (BIC)/ Lenacapavir (LEN) (75/50 mg) + PTM B/F/TAF 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: Bictegravir Tablets administered orally without regard to food Other Names: GS-9883 Drug: Lenacapavir Tablets administered orally without regard to food Other Names: GS-6207 Drug: Placebo to match B/F/TAF Tablets administered orally without regard to food
Experimental: Treatment Group 2: B/F/TAF (50/200/25 mg) + PTM BIC/LEN 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: Bictegravir Tablets administered orally without regard to food Other Names: GS-9883 Drug: Lenacapavir Tablets administered orally without regard to food Other Names: GS-6207 Drug: B/F/TAF Tablets administered orally without regard to food Other Names: Biktarvy ® Drug: Placebo to match BIC/LEN Tablets administered orally without regard to food

Participant Group / Arm

Intervention / Treatment

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

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: Bictegravir