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


June 14, 2024 ID



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)


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).

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Participation Requirements



18 Years +




Healthy Icon

Healthy Volunteers


Study Details

Medical Condition





August 2022 - January 2026

Study Type


Study Phase

Phase 2, Phase 3


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 (92)
Study Complete

Be Well Medical Center

Berkeley, California, United States, 48072

Study Complete

Pacific Oaks Medical Group

Beverly Hills, California, United States, 90211

Study Complete

Ruane Clinical Research Group, Inc

Los Angeles, California, United States, 90036

Study Complete

Bios Clinical Research

Palm Springs, California, United States, 92262

Study Complete

University of California San Diego (UCSD)

San Diego, California, United States, 92103


Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center

Torrance, California, United States, 90502

Study Complete

The Men's Health Foundation

West Hollywood, California, United States, 90046

Study Complete

Denver Health Medical Center

Denver, Colorado, United States, 80204

Recruitment Complete

Yale University; School of Medicine; AIDS Program

New Haven, Connecticut, United States, 06510

Study Complete

Midland Florida Clinical Research Center, LLC

DeLand, Florida, United States, 32720


Therafirst Medical Centers

Fort Lauderdale, Florida, United States, 33308

Study Complete

Gary Richmond, MD, PA, Inc.

Fort Lauderdale, Florida, United States, 33316

Study Complete

Midway Immunology & Research Center, LLC

Fort Pierce, Florida, United States, 34982

Study Complete

Floridian Clinical Research

Miami Lakes, Florida, United States, 33016

Recruitment Complete

Schiff Center for liver Diseases/University of Miami

Miami, Florida, United States, 33136


Orlando Immunology Center

Orlando, Florida, United States, 32803

Study Complete

Therapeutic Concepts, PA

Orlando, Florida, United States, 32803

Study Complete

Triple O Research Institute PA

West Palm Beach, Florida, United States, 33407


Atlanta ID Group

Atlanta, Georgia, United States, 30309

Study Complete

Mercer University School of Medicine

Macon, Georgia, United States, 31201

Study Complete

Howard Brown Health Center

Chicago, Illinois, United States, 60613


Kansas City Care Clinic

Kansas City, Missouri, United States, 64111


Southampton Healthcare, Inc.

Saint Louis, Missouri, United States, 63139

Study Complete

Saint Michael's Medical Center

Newark, New Jersey, United States, 07102

Study Complete

AXCES Research Group

Santa Fe, New Mexico, United States, 87505

Study Complete

New York Presbyterian Hospital

Flushing, New York, United States, 11355

Study Complete

Ricky K. Hsu, MD, PC

New York, New York, United States, 10001

Study Complete

East Carolina University

Greenville, North Carolina, United States, 27858

Study Complete

Philadelphia FIGHT

Philadelphia, Pennsylvania, United States, 19107


Medical University of South Carolina (MUSC) Research NEXUS

Charleston, South Carolina, United States, 29425

Study Complete

Central Texas Clinical Research

Austin, Texas, United States, 78705

Study Complete

St. Hope Foundation

Bellaire, Texas, United States, 77401

Study Complete

AIDS Arms, Inc., DBA Prism Health North Texas

Dallas, Texas, United States, 75208

Study Complete

North Texas Infectious Diseases Consultants

Dallas, Texas, United States, 75246

Study Complete

Texas Centers for Infectious Disease Associates

Fort Worth, Texas, United States, 76104

Study Complete

Gordon E. Crofoot MD PA

Houston, Texas, United States, 77098

Study Complete

Diagnostic Clinic of Longview - Center for Clinical Research

Longview, Texas, United States, 75605

Study Complete

Peter Shalit, MD

Seattle, Washington, United States, 98104


Hospital General de Agudos J.M Ramon Mejia

Buenos Aires, Argentina, 1072


Fundación Huésped

Buenos Aires, Argentina, 1202


Helios Salud

Buenos Aires, Argentina, 1425


St.Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia, 2010


Taylor Square Private Clinic

Darlinghurst, New South Wales, Australia, 2011

Study Complete

Holdsworth House Medical Practice

Sydney, New South Wales, Australia, 2010

Recruitment Complete

Alfred Health

Melbourne, Victoria, Australia, 3004

Study Complete

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

Decarie Montreal, Canada, H4A 3J1

Study Complete

Clinique Medicale du Quartier Latin

Montreal, Canada, H2L 0B1

Recruitment Complete

The Ottawa Hospital - General Campus

Ottawa, Canada, K1H 8L6

Study Complete

ID Clinic

Regina, Canada, S4P 0W5

Study Complete

Maple Leaf Research

Toronto, Canada, M5G 1K2

Study Complete

Spectrum Health

Vancouver, Canada, V6Z 2T1

Study Complete

Instituto Dominicano de Estudio Virologicos - IDEV

Santo Domingo, Dominican Republic

Recruitment Complete

CHU Nice-Hôpital l'Archet

Nice Cedex 03, France, 6202


Höpital de la Pitié Salpêtrière

Paris Cedex 13, France, 75651


Hospital Saint Louis

Paris, France, 75010


Groupe Hospitalier Bichat Claude Bernard

Paris, France, 75018


zibp Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH

Berlin, Germany, 10439


Universitatsklinikum Bonn

Bonn, Germany, 53127


Infektio Research GmbH & Co.KG

Frankfurt, Germany, 60596


ICH Study Center GmbH & Co. KG

Hamburg, Germany, 20146


MVZ München am Goetheplatz

München, Germany


IRCCS Ospedale San Raffaele

Milano, Italy, 20127

Recruitment Complete

ASST Fatebenefratelli Sacco

Milano, Italy, 20157


Azienda Ospedaliero-Universitaria di Modena

Modena, Italy, 40124


Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS

Roma, Italy, 00149

Recruitment Complete

ASL Città di Torino

Torino, Italy, 10149


National Hospital Organization Nagoya Medical Center

Nagoya, Japan


National Hospital Organization Osaka National Hospital

Osaka, Japan, 540-0006


Center Hospital of the National Center for Global Health and Medicine

Tokyo, Japan, 162-0052

Recruitment Complete

Kyungpook National University Hospital

Daegu, Korea, Republic of, 41944

Will Be Recruiting

Chungnam National University Hospital

Daejeon, Korea, Republic of, 35015


Yonsei University Severance Hospital

Seoul, Korea, Republic of, 03722


The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, Korea, Republic of, 06591

Study Complete

Hope Clinical Research

San Juan, Puerto Rico, 00909

Study Complete

Proyecto ACTU

San Juan, Puerto Rico, 00935


Desmond Tutu Health Foundation Clinical Trials Unit

Cape Town, South Africa, 7925


Sefako Makgatho Health Sciences University

Ga Rankuwa, South Africa, 208



Johannesburg, South Africa, 2193

Recruitment Complete

Hospital Clinic Provincial de Barcelona

Barcelona, Spain, 08036

Recruitment Complete

Hospital Ramon y Cajal, Madrid

Madrid, Spain, 28034

Recruitment Complete

Hospital Clinico San Carlos

Madrid, Spain, 28040

Recruitment Complete

Hospital Universitario La Paz

Madrid, Spain, 28046

Recruitment Complete

Hospital Universitario Virgen del Rocio

Sevilla, Spain, 4103


Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, 80756


Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, 81362

Will Be Recruiting

Far Eastern Memorial Hospital

New Taipei City, Taiwan, 22060


Taoyuan General Hospital

Taoyuan City, Taiwan, 33004

Recruitment Complete

Department of HIV & Sexual Medicine

Birmingham, United Kingdom, B9 5SS

Recruitment Complete

Brighton and Sussex University Hospitals NHS Trust

Brighton, United Kingdom, BN2 3EW

Recruitment Complete

Barts Health NHS Trust

London, United Kingdom, E1 1BB.


HIV medicine and infectious diseases

London, United Kingdom, SE5 9RS


St.Stephen's AIDS Trust, Clinical Trials Unit, 1st Floor, St.Stephen's Centre

London, United Kingdom, SW109NH