Study Details

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

Medical Condition

HIV-1-infection

Gender

N/A

Date

August 2022 - September 2025

Study Type

INTERVENTIONAL

Study Phase

PHASE2, PHASE3

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

Pacific Oaks Medical Group

Beverly Hills, California, United States, 90211

Ruane Clinical Research Group, Inc

Los Angeles, California, United States, 90036

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

Oakland, California, United States, 94609

Bios Clinical Research

Palm Springs, California, United States, 92262

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

The Men's Health Foundation

West Hollywood, California, United States, 90046

Denver Health Medical Center

Denver, Colorado, United States, 80204

Yale University; School of Medicine; AIDS Program

New Haven, Connecticut, United States, 06510

Midland Florida Clinical Research Center, LLC

DeLand, Florida, United States, 32720

Therafirst Medical Centers

Fort Lauderdale, Florida, United States, 33308

Gary Richmond, MD, PA, Inc.

Fort Lauderdale, Florida, United States, 33316

Midway Immunology & Research Center, LLC

Fort Pierce, Florida, United States, 34982

Floridian Clinical Research

Miami Lakes, Florida, United States, 33016

Schiff Center for liver Diseases/University of Miami

Miami, Florida, United States, 33136

Orlando Immunology Center

Orlando, Florida, United States, 32803

Therapeutic Concepts, PA

Orlando, Florida, United States, 32803

Triple O Research Institute PA

West Palm Beach, Florida, United States, 33407

Atlanta ID Group

Atlanta, Georgia, United States, 30309

Mercer University School of Medicine

Macon, Georgia, United States, 31201

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

Saint Michael's Medical Center

Newark, New Jersey, United States, 07102

AXCES Research Group

Santa Fe, New Mexico, United States, 87505

New York Presbyterian Hospital

Flushing, New York, United States, 11355

Ricky K. Hsu, MD, PC

New York, New York, United States, 10001

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States, 27514

East Carolina University

Greenville, North Carolina, United States, 27858

Philadelphia FIGHT

Philadelphia, Pennsylvania, United States, 19107

Medical University of South Carolina (MUSC) Research NEXUS

Charleston, South Carolina, United States, 29425

Central Texas Clinical Research

Austin, Texas, United States, 78705

St. Hope Foundation

Bellaire, Texas, United States, 77401

AIDS Arms, Inc., DBA Prism Health North Texas

Dallas, Texas, United States, 75208

North Texas Infectious Diseases Consultants

Dallas, Texas, United States, 75246

Texas Centers for Infectious Disease Associates

Fort Worth, Texas, United States, 76104

Gordon E. Crofoot MD PA

Houston, Texas, United States, 77098

Diagnostic Clinic of Longview - Center for Clinical Research

Longview, Texas, United States, 75605

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

Holdsworth House Medical Practice

Sydney, New South Wales, Australia, 2010

Alfred Health

Melbourne, Victoria, Australia, 3004

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

Decarie Montreal, Canada, H4A 3J1

Clinique Medicale du Quartier Latin

Montreal, Canada, H2L 0B1

The Ottawa Hospital - General Campus

Ottawa, Canada, K1H 8L6

ID Clinic

Regina, Canada, S4P 0W5

Maple Leaf Research

Toronto, Canada, M5G 1K2

Spectrum Health

Vancouver, Canada, V6Z 2T1

Instituto Dominicano de Estudio Virologicos - IDEV

Santo Domingo, Dominican Republic

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

ASST Fatebenefratelli Sacco

Milano, Italy, 20157

Azienda Ospedaliero-Universitaria di Modena

Modena, Italy, 40124

Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS

Roma, Italy, 00149

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

Kyungpook National University Hospital

Daegu, Korea, Republic of, 41944

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

Hope Clinical Research

San Juan, Puerto Rico, 00909

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

Ezintsha

Johannesburg, South Africa, 2193

Hospital Clinic Provincial de Barcelona

Barcelona, Spain, 08036

Hospital Ramon y Cajal, Madrid

Madrid, Spain, 28034

Hospital Clinico San Carlos

Madrid, Spain, 28040

Hospital Universitario La Paz

Madrid, Spain, 28046

Hospital Universitario Virgen del Rocio

Sevilla, Spain, 4103

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, 80756