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 (7)

Ruane Medical and Clinical Research Institute

Los Angeles, California, United States, 90036

Therafirst Medical Center

Fort Lauderdale, Florida, United States, 33308

Midway Immunology and Research Center

Fort Pierce, Florida, United States, 34982

Infectious Disease Specialists of Atlanta

Decatur, Georgia, United States, 30033

Southhampton Community Healthcare, Inc.

Saint Louis, Missouri, United States, 63139

South Jersey Infectious Disease

Somers Point, New Jersey, United States, 08244

The Crofoot research Center, INC.

Houston, Texas, United States, 77098

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