Study Details

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

Medical Condition

HIV-1-infection

Gender

N/A

Date

March 2024 - December 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 (45)

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

UCSD Anti Viral Research Centre (AVRC)

San Diego, California, United States, 92103

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, United States, 90502

Mills Clinical Research

West Hollywood, California, United States, 90046

Midland Florida Infectious Diseases Specialists, PL - Orange City

DeLand, Florida, United States, 32720

Therafirst Medical Center

Fort Lauderdale, Florida, United States, 33308

CAN Community Health

Fort Lauderdale, Florida, United States, 33316

Midway Immunology and Research Center

Fort Pierce, Florida, United States, 34982

Floridian Clinical Research

Miami Lakes, Florida, United States, 33016

AIDS Healthcare Foundation - The Kinder Medical Group

Miami, Florida, United States, 33133

Orlando Immunology Center

Orlando, Florida, United States, 32803

AHF Pensacola

Pensacola, Florida, United States, 32503

CAN community Health

Sarasota, Florida, United States, 34237

Triple O Research Institute, P.A.

West Palm Beach, Florida, United States, 33407

Infectious Disease Specialists of Atlanta

Decatur, Georgia, United States, 30033

Mercer University, Department of Internal Medicine

Macon, Georgia, United States, 31201

Claudia T Martorell MD LLC dba The Research Institute

Springfield, Massachusetts, United States, 01105

Southampton Community Healthcare, Inc.

Saint Louis, Missouri, United States, 63139

ID Care, LLC

Hillsborough, New Jersey, United States, 08844

Saint Michael's Medical Center

Newark, New Jersey, United States, 07102

South Jersey Infectious Disease

Somers Point, New Jersey, United States, 08244

AXCES Research Group, LLC

Santa Fe, New Mexico, United States, 87505

Montefiore Medical Center

Bronx, New York, United States, 10467

New York-Presbyterian Queens

Flushing, New York, United States, 11355

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

Greenville, North Carolina, United States, 27858

Rosedale Health and Wellness

Huntersville, North Carolina, United States, 28078

Philadelphia FIGHT Community Health Centers

Philadelphia, Pennsylvania, United States, 19107

Central Texas Clinical Research

Austin, Texas, United States, 78705

St Hope Foundation, Inc.

Bellaire, Texas, United States, 77401

AIDS Arms, Inc. DBA Prism Health North Texas

Dallas, Texas, United States, 75208

North Texas Infectious Diseases Consultants, PA

Dallas, Texas, United States, 75246

AXCES Research Group, LLC

El Paso, Texas, United States, 79902

Texas Centers for Infectious Disease Associates

Fort Worth, Texas, United States, 76104

The Crofoot research Center, INC.

Houston, Texas, United States, 77098

AXCES Research Group, LLC

Salt Lake City, Utah, United States, 84102

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

Annandale, Virginia, United States, 22003

Peter Shalit MD

Seattle, Washington, United States, 98104

Community Health care

Tacoma, Washington, United States, 98405

Taylor Square Private Clinic

Darlinghurst, New South Wales, Australia, 2011

Prahran Market Clinic

South Yarra, Victoria, Australia, 3141

Cool Aid Community Health Centre

Victoria, Canada, V8W 1M8

National Hospital Organization Osaka National Hospital

Osaka, Japan, 540-0006

HOPE Clinical Research

San Juan, Puerto Rico, 00909

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

OVERVIEW

PROTOCOL SUMMARY

Participation Requirements

Eligibility Information

Inclusion Criteria

Exclusion Criteria

Locations

Locations (45)

Be Well Medical Center

Pacific Oaks Medical Group

Ruane Clinical Research Group Inc.

UCSD Anti Viral Research Centre (AVRC)

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Mills Clinical Research

Midland Florida Infectious Diseases Specialists, PL - Orange City

Therafirst Medical Center

CAN Community Health

Midway Immunology and Research Center

Floridian Clinical Research

AIDS Healthcare Foundation - The Kinder Medical Group

Orlando Immunology Center

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

Southampton Community Healthcare, Inc.

ID Care, LLC

Saint Michael's Medical Center

South Jersey Infectious Disease

AXCES Research Group, LLC

Montefiore Medical Center

New York-Presbyterian Queens

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

Rosedale Health and Wellness

Philadelphia FIGHT Community Health Centers

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

Taylor Square Private Clinic

Prahran Market Clinic

Cool Aid Community Health Centre

National Hospital Organization Osaka National Hospital

HOPE Clinical Research