STATUS Recruitment Complete

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

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

STATUS

Recruitment Complete

GILEAD STUDY ID

GS-US-621-6289

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

LAST UPDATED

October 14, 2025

Clinicaltrials.gov ID

CTSID

CTSID

CTSID

OVERVIEW

An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens (ARTISTRY-1)

PROTOCOL SUMMARY

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).

Participation requirements

Age

18 years +

Sex

All

Healthy Volunteers

Study details

Medical Condition

HIV-1-infection

Gender

N/A

Date

August 2022 - September 2025

Study Type

Interventional

Study Phase

Phase 2, Phase 3

Product

Bictegravir, Lenacapavir, BIC/LEN FDC, Stable Baseline Regimen

Eligibility information

Inclusion criteria

If plasma HIV-1 RNA measurements in the 6 months prior to screening are available, all levels must be < 50 copies/mL.
At least one documented plasma 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.
Currently receiving a complex antiretroviral (ARV) regimen due to previous viral resistance, or intolerance, or contraindication to existing single-tablet regimens (STR), and on this regimen for at least 6 months prior to the screening visit. The criteria to define a complex regimen in this study are as follows:
A regimen containing a boosted protease inhibitor or a nonnucleos(t)ide reverse transcriptase inhibitor (NRTI) plus at least 1 other third agent (ie, an agent from a class other than NRTIs) (eg, bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®)(BVY) + darunavir/cobicistat, BVY + etravirine), or
A regimen of ≥ 2 pills/day, or a regimen requiring dosing more than once daily, or
A regimen containing parenteral agent(s) (excluding a complete long-acting injectable regimen, such as intramuscular cabotegravir plus rilpivirine) as well as oral agents.
No documented or suspected resistance to bictegravir (BIC).
Estimated glomerular filtration rate ≥ 15 mL/min according to the Cockcroft-Gault formula for creatinine clearance (CLcr) who are not on renal replacement therapy.

Exclusion criteria

Prior use of, or exposure to, lenacapavir (LEN)
Active tuberculosis infection
Chronic hepatitis B virus (HBV) infection
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

Locations (94)

Be Well Medical Center

Berkeley, California, United States, 48072

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

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 (94)

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

University of California San Diego (UCSD)

Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center

The Men's Health Foundation

Denver Health Medical Center

Yale University; School of Medicine; AIDS Program

Midland Florida Clinical Research Center, LLC

Therafirst Medical Centers

Gary Richmond, MD, PA, Inc.

Midway Immunology & Research Center, LLC

Schiff Center for liver Diseases/University of Miami

Floridian Clinical Research

Orlando Immunology Center

Therapeutic Concepts, PA

Triple O Research Institute PA

Atlanta ID Group

Mercer University School of Medicine

Howard Brown Health Center

Kansas City Care Clinic

Southampton Healthcare, Inc.

Saint Michael's Medical Center

AXCES Research Group

New York Presbyterian Hospital

Ricky K. Hsu, MD, PC

University of North Carolina - Chapel Hill

East Carolina University

Philadelphia FIGHT

Medical University of South Carolina (MUSC) Research NEXUS

Central Texas Clinical Research

St. Hope Foundation

AIDS Arms, Inc., DBA Prism Health North Texas

North Texas Infectious Diseases Consultants

Texas Centers for Infectious Disease Associates

Gordon E. Crofoot MD PA

Diagnostic Clinic of Longview - Center for Clinical Research

Peter Shalit, MD

Hospital General de Agudos J.M Ramon Mejia

Fundación Huésped

Helios Salud

St.Vincent's Hospital Sydney

Taylor Square Private Clinic

Holdsworth House Medical Practice

Alfred Health

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

Clinique Medicale du Quartier Latin

The Ottawa Hospital - General Campus

ID Clinic

Maple Leaf Research

Spectrum Health

Instituto Dominicano de Estudio Virologicos - IDEV

CHU Nice-Hôpital l'Archet

Hospital Saint Louis

Groupe Hospitalier Bichat Claude Bernard

Höpital de la Pitié Salpêtrière

zibp Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH

Universitatsklinikum Bonn

Infektio Research GmbH & Co.KG

ICH Study Center GmbH & Co. KG

MVZ München am Goetheplatz

IRCCS Ospedale San Raffaele

ASST Fatebenefratelli Sacco

Azienda Ospedaliero-Universitaria di Modena

Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS

ASL Città di Torino