STATUS Recruitment Complete

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

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

STATUS

Recruitment Complete

GILEAD STUDY ID

GS-US-621-6290

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

LAST UPDATED

June 15, 2026

Clinicaltrials.gov ID

NCT06333808

CTSID

2023-510022-33

OVERVIEW

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 (ARTISTRY-2)

PROTOCOL 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.

Participation requirements

Age

18 years +

Sex

All

Healthy Volunteers

Study details

Medical Condition

HIV-1-infection

Gender

N/A

Date

March 2024 - October 2025

Study Type

Interventional

Study Phase

Phase 3

Product

Bictegravir, Lenacapavir, B/F/TAF, Placebo to match B/F/TAF, Placebo to match BIC/LEN

Eligibility information

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.

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.

Locations

Locations (104)

Pueblo Family Physicians

Phoenix, Arizona, United States, 85015

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

For more information, please contact the

For more information, please contact the

OVERVIEW

PROTOCOL SUMMARY

Participation requirements

Study details

Eligibility information

Inclusion criteria

Exclusion criteria

Locations

Locations (104)

Pueblo Family Physicians

Be Well Medical Center

Pacific Oaks Medical Group

Ruane Clinical Research Group Inc.

Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care

BIOS Clinical Research

UCSD Anti Viral Research Centre (AVRC)

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Mills Clinical Research

Public Health Institute at Denver Health

Yale University School of Medicine (study visits)

Midland Florida Infectious Diseases Specialists, PL - Orange City

Therafirst Medical Center

CAN Community Health

Midway Immunology and Research Center

AIDS Healthcare Foundation - The Kinder Medical Group

Schiff Center for liver Diseases/University of Miami

Floridian Clinical Research

Orlando Immunology Center

Bliss Healthcare

AHF Pensacola

CAN community Health

Triple O Research Institute, P.A.

Infectious Disease Specialists of Atlanta

Mercer University, Department of Internal Medicine

Claudia T Martorell MD LLC dba The Research Institute

Henry Ford Health

KC Care health Center

Southampton Community Healthcare, Inc.

ID Care, LLC

Saint Michael's Medical Center

New Jersey Medical School - Clinical Research Center

South Jersey Infectious Disease

AXCES Research Group, LLC

New York-Presbyterian Queens

Montefiore Medical Center

The Brody School of Medicine at East Carolina University , ECU Adult Specialty Care

Rosedale Health and Wellness

Philadelphia FIGHT Community Health Centers

Medical University of South Carolina (MUSC) Research Nexus

Central Texas Clinical Research

St Hope Foundation, Inc.

AIDS Arms, Inc. DBA Prism Health North Texas

North Texas Infectious Diseases Consultants, PA

AXCES Research Group, LLC

Texas Centers for Infectious Disease Associates

The Crofoot research Center, INC.

AXCES Research Group, LLC

Clinical Alliance For Research & Education - Infectious Diseases. LLC (CARE-ID)

Peter Shalit MD

Community Health care

Helios Salud S.A.

Fundacion Huesped

Instituto CAICI SRL

Taylor Square Private Clinic

Alfred Hospital(Alfred Health)

Prahran Market Clinic

Chronic Viral Illness Service/McGill University Health Centre (MUHC)

Clinique Médicale l'Actuel

The Ottawa Hospital - General Campus

Regina General Hospital

St. Paul's Hospital, John Ruedy Clinic-Immunodeficiency Clinic (JRC-IDC)

Cool Aid Community Health Centre

Instituto Dominicano de Estudios Virologicos - IDEV

Praxis Dr. Knechten

Novopraxis Berlin

Praxis am Ebertplatz

Universitätsklinikum Frankfurt