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

HIV-1-infection Clinical Trial

— ARTISTRY-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05502341
• Other study ID #: GS-US-621-6289
• Secondary ID: 2022-500929-33DO
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 16, 2022
• Est. completion date: November 2028

Study information

• Verified date: May 2024
• Source: Gilead Sciences
• Contact: Gilead Clinical Study Information Center
• Phone: 1-833-445-3230 (GILEAD-0)
• Email: GileadClinicalTrials[@]gilead.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 671
• Est. completion date: November 2028
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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.

Key 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.

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

Drug:
• Bictegravir
Tablets administered orally without regard to food
• Lenacapavir
Tablets administered orally without regard to food
• BIC/LEN FDC
Tablets administered orally without regard to food
• Stable Baseline Regimen
SBR will include a combination of antiretroviral (ARV) regimen. ARV regimen may include the following, except for participants taking a single tablet regimen or taking a complete parenteral regimen (Cabenuva). Nucleos(t)ide Reverse Transcriptase Inhibitors: Abacavir Emtricitabine Lamivudine Tenofovir alafenamide Tenofovir disoproxil fumarate Zidovudine Non-Nucleosite Reverse Transcriptase Inhibitors: Delavirdine Efavirenz Nevirapine Rilpivirine Doravirine Integrase Inhibitors: Bictegravir Cabotegravir Dolutegravir Elvitegravir Raltegravir Protease Inhibitors: Atazanavir Darunavir Fosamprenavir Indinavir Lopinavir Nelfinavir Saquinavir Tipranavir Chemokine Co-receptor 5 (CCR5) Antagonist: Maraviroc Fusion Inhibitors: Enfuvirtide gp120 Attachment Inhibitor: Fostemsavir Anti-CD4 Monoclonal Antibodies: Ibalizumab-uiyk

Locations

Country	Name	City	State
Argentina	Fundación Huésped	Buenos Aires
Argentina	Helios Salud	Buenos Aires
Australia	Taylor Square Private Clinic	Darlinghurst	New South Wales
Australia	Alfred Health	Melbourne	Victoria
Australia	Holdsworth House Medical Practice	Sydney	New South Wales
Canada	Chronic Viral Illness Service / McGill University Health Centre (MUHC)	Decarie Montreal
Canada	Clinique Medicale du Quartier Latin	Montreal
Canada	The Ottawa Hospital - General Campus	Ottawa
Canada	ID Clinic	Regina
Canada	Maple Leaf Research	Toronto
Canada	Spectrum Health	Vancouver
Dominican Republic	Instituto Dominicano de Estudio Virologicos - IDEV	Santo Domingo
France	CHU Nice-Hôpital l'Archet	Nice Cedex 03
France	Groupe Hospitalier Bichat Claude Bernard	Paris
France	Hospital Saint Louis	Paris
France	Höpital de la Pitié Salpêtrière	Paris Cedex 13
Germany	zibp Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH	Berlin
Germany	Universitatsklinikum Bonn	Bonn
Germany	Infektio Research GmbH & Co.KG	Frankfurt
Germany	ICH Study Center GmbH & Co. KG	Hamburg
Germany	MVZ München am Goetheplatz	München
Italy	ASST Fatebenefratelli Sacco	Milano
Italy	IRCCS Ospedale San Raffaele	Milano
Italy	Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS	Roma
Italy	ASL Città di Torino	Torino
Japan	National Hospital Organization Nagoya Medical Center	Nagoya
Japan	National Hospital Organization Osaka National Hospital	Osaka
Japan	Center Hospital of the National Center for Global Health and Medicine	Tokyo
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Yonsei University Severance Hospital	Seoul
Puerto Rico	Hope Clinical Research	San Juan
Puerto Rico	Proyecto ACTU	San Juan
South Africa	Desmond Tutu Health Foundation Clinical Trials Unit	Cape Town
South Africa	Sefako Makgatho Health Sciences University	Ga Rankuwa
South Africa	Ezintsha	Johannesburg
Spain	Hospital Clinic Provincial de Barcelona	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Ramon y Cajal, Madrid	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung City
Taiwan	Far Eastern Memorial Hospital	New Taipei City
Taiwan	Taoyuan General Hospital	Taoyuan City
United Kingdom	Department of HIV & Sexual Medicine	Birmingham
United Kingdom	Brighton and Sussex University Hospitals NHS Trust	Brighton
United Kingdom	Barts Health NHS Trust	London
United Kingdom	HIV medicine and infectious diseases	London
United Kingdom	St.Stephen's AIDS Trust, Clinical Trials Unit, 1st Floor, St.Stephen's Centre	London
United States	Atlanta ID Group	Atlanta	Georgia
United States	Central Texas Clinical Research	Austin	Texas
United States	St. Hope Foundation	Bellaire	Texas
United States	Be Well Medical Center	Berkeley	California
United States	Pacific Oaks Medical Group	Beverly Hills	California
United States	Medical University of South Carolina (MUSC) Research NEXUS	Charleston	South Carolina
United States	Howard Brown Health Center	Chicago	Illinois
United States	AIDS Arms, Inc., DBA Prism Health North Texas	Dallas	Texas
United States	North Texas Infectious Diseases Consultants	Dallas	Texas
United States	Midland Florida Clinical Research Center, LLC	DeLand	Florida
United States	Denver Health Medical Center	Denver	Colorado
United States	New York Presbyterian Hospital	Flushing	New York
United States	Gary Richmond, MD, PA, Inc.	Fort Lauderdale	Florida
United States	Therafirst Medical Centers	Fort Lauderdale	Florida
United States	Midway Immunology & Research Center, LLC	Fort Pierce	Florida
United States	Texas Centers for Infectious Disease Associates	Fort Worth	Texas
United States	East Carolina University	Greenville	North Carolina
United States	Gordon E. Crofoot MD PA	Houston	Texas
United States	Kansas City Care Clinic	Kansas City	Missouri
United States	Diagnostic Clinic of Longview - Center for Clinical Research	Longview	Texas
United States	Ruane Clinical Research Group, Inc	Los Angeles	California
United States	Mercer University School of Medicine	Macon	Georgia
United States	Schiff Center for liver Diseases/University of Miami	Miami	Florida
United States	Floridian Clinical Research	Miami Lakes	Florida
United States	Yale University; School of Medicine; AIDS Program	New Haven	Connecticut
United States	Ricky K. Hsu, MD, PC	New York	New York
United States	Saint Michael's Medical Center	Newark	New Jersey
United States	Orlando Immunology Center	Orlando	Florida
United States	Therapeutic Concepts, PA	Orlando	Florida
United States	Bios Clinical Research	Palm Springs	California
United States	Philadelphia FIGHT	Philadelphia	Pennsylvania
United States	Southampton Healthcare, Inc.	Saint Louis	Missouri
United States	University of California San Diego (UCSD)	San Diego	California
United States	AXCES Research Group	Santa Fe	New Mexico
United States	Peter Shalit, MD	Seattle	Washington
United States	Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center	Torrance	California
United States	The Men's Health Foundation	West Hollywood	California
United States	Triple O Research Institute PA	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Dominican Republic,  France,  Germany,  Italy,  Japan,  Korea, Republic of,  Puerto Rico,  South Africa,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 2: Proportion of Participants With HIV-1 RNA = 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm		Week 24
Primary	Phase 3: Proportion of Participants With HIV-1 RNA = 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm		Week 48
Secondary	Phase 2: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm		Week 24
Secondary	Phase 2: Change From Baseline in CD4 Cell Count at Week 24		Baseline, Week 24
Secondary	Phase 2: Percentage of Participants Experiencing Treatment-emergent Adverse Events (AEs) Through Week 24		First dose date up to Week 24
Secondary	Phase 2: Pharmacokinetic (PK) Parameter: Cmax of Bictegravir (BIC) and Lenacapavir (LEN) at Steady State	Cmax is defined as the maximum observed concentration of drug.	Day 1 up to Week 24
Secondary	Phase 2: PK Parameter: AUCtau of BIC and LEN at Steady State	AUCtau is defined as the area under the concentration versus time curve over the dosing interval.	Day 1 up to Week 24
Secondary	Phase 2: PK Parameter: Ctau of BIC and LEN at Steady State	Ctau is defined as the observed drug concentration at the end of the dosing interval.	Day 1 up to Week 24
Secondary	Phase 3: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm		Week 48
Secondary	Phase 3: Change From Baseline in CD4 Cell Count at Week 48		Baseline, Week 48
Secondary	Phase 3 (BIC/LEN 75 mg/50 mg FDC): Proportion of Participants from With HIV-1 RNA = 50 Copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm		Week 96
Secondary	Phase 3 (BIC/LEN 75 mg/50 mg FDC): Change From Baseline in CD4 Cell Count at Week 96		Baseline, Week 96
Secondary	Phase 3: Percentage of Participants Experiencing Treatment-emergent AEs Through Week 48		First dose date up to Week 48
Secondary	Phase 3 (BIC/LEN 75 mg/50 mg FDC): Proportion of Participants from Experiencing Treatment-emergent AEs Through Week 96		Week 96

External Links

•   Gilead Clinical Trials Website