Clinical trial NCT05502341: Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: HIV-1-infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2022-08-16
Enrollment: 689
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm
timeFrame: Week 24
measure: Phase 3: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
timeFrame: Week 48
Secondary outcomes:
measure: Phase 2: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm
timeFrame: Week 24
measure: Phase 2: Change From Baseline in CD4 Cell Count at Week 24
timeFrame: Baseline, Week 24
measure: Phase 2: Percentage of Participants Experiencing Treatment-emergent Adverse Events (AEs) Through Week 24
timeFrame: First dose date up to Week 24
measure: Phase 2: Pharmacokinetic (PK) Parameter: Cmax of Bictegravir (BIC) and Lenacapavir (LEN) at Steady State
timeFrame: Day 1 up to Week 24
measure: Phase 2: PK Parameter: AUCtau of BIC and LEN at Steady State
timeFrame: Day 1 up to Week 24
measure: Phase 2: PK Parameter: Ctau of BIC and LEN at Steady State
timeFrame: Day 1 up to Week 24
measure: Phase 3: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
timeFrame: Week 48
measure: Phase 3: Change From Baseline in CD4 Cell Count at Week 48
timeFrame: Baseline, Week 48
measure: 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
timeFrame: Week 96
measure: Phase 3 (BIC/LEN 75 mg/50 mg FDC): Change From Baseline in CD4 Cell Count at Week 96
timeFrame: Baseline, Week 96
measure: Phase 3: Percentage of Participants Experiencing Treatment-emergent AEs Through Week 48
timeFrame: First dose date up to Week 48
measure: Phase 3 (BIC/LEN 75 mg/50 mg FDC): Proportion of Participants from Experiencing Treatment-emergent AEs Through Week 96
timeFrame: Week 96
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Be Well Medical Center
state: California
city: Beverly Hills
country: United States
facility: Pacific Oaks Medical Group
state: California
city: Los Angeles
country: United States
facility: Ruane Clinical Research Group, Inc
state: California
city: Oakland
country: United States
facility: Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care
state: California
city: Palm Springs
country: United States
facility: Bios Clinical Research
state: California
city: San Diego
country: United States
facility: University of California San Diego (UCSD)
state: California
city: Torrance
country: United States
facility: Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
state: California
city: West Hollywood
country: United States
facility: The Men's Health Foundation
state: California
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: New Haven
country: United States
facility: Yale University; School of Medicine; AIDS Program
state: Connecticut
city: DeLand
country: United States
facility: Midland Florida Clinical Research Center, LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: Therafirst Medical Centers
state: Florida
city: Fort Lauderdale
country: United States
facility: Gary Richmond, MD, PA, Inc.
state: Florida
city: Fort Pierce
country: United States
facility: Midway Immunology & Research Center, LLC
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Clinical Research
state: Florida
city: Miami
country: United States
facility: Schiff Center for liver Diseases/University of Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Orlando
country: United States
facility: Therapeutic Concepts, PA
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Research Institute PA
state: Florida
city: Atlanta
country: United States
facility: Atlanta ID Group
state: Georgia
city: Macon
country: United States
facility: Mercer University School of Medicine
state: Georgia
city: Chicago
country: United States
facility: Howard Brown Health Center
state: Illinois
city: Kansas City
country: United States
facility: Kansas City Care Clinic
state: Missouri
city: Saint Louis
country: United States
facility: Southampton Healthcare, Inc.
state: Missouri
city: Newark
country: United States
facility: Saint Michael's Medical Center
state: New Jersey
city: Santa Fe
country: United States
facility: AXCES Research Group
state: New Mexico
city: Flushing
country: United States
facility: New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Ricky K. Hsu, MD, PC
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina - Chapel Hill
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Philadelphia
country: United States
facility: Philadelphia FIGHT
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC) Research NEXUS
state: South Carolina
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: Bellaire
country: United States
facility: St. Hope Foundation
state: Texas
city: Dallas
country: United States
facility: AIDS Arms, Inc., DBA Prism Health North Texas
state: Texas
city: Dallas
country: United States
facility: North Texas Infectious Diseases Consultants
state: Texas
city: Fort Worth
country: United States
facility: Texas Centers for Infectious Disease Associates
state: Texas
city: Houston
country: United States
facility: Gordon E. Crofoot MD PA
state: Texas
city: Longview
country: United States
facility: Diagnostic Clinic of Longview - Center for Clinical Research
state: Texas
city: Seattle
country: United States
facility: Peter Shalit, MD
state: Washington
city: Buenos Aires
country: Argentina
facility: Hospital General de Agudos J.M Ramon Mejia
city: Buenos Aires
country: Argentina
facility: Fundación Huésped
city: Buenos Aires
country: Argentina
facility: Helios Salud
city: Darlinghurst
country: Australia
facility: St.Vincent's Hospital Sydney
state: New South Wales
city: Darlinghurst
country: Australia
facility: Taylor Square Private Clinic
state: New South Wales
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Melbourne
country: Australia
facility: Alfred Health
state: Victoria
city: Decarie Montreal
country: Canada
facility: Chronic Viral Illness Service / McGill University Health Centre (MUHC)
city: Montreal
country: Canada
facility: Clinique Medicale du Quartier Latin
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
city: Regina
country: Canada
facility: ID Clinic
city: Toronto
country: Canada
facility: Maple Leaf Research
city: Vancouver
country: Canada
facility: Spectrum Health
city: Santo Domingo
country: Dominican Republic
facility: Instituto Dominicano de Estudio Virologicos - IDEV
city: Nice Cedex 03
country: France
facility: CHU Nice-Hôpital l'Archet
city: Paris Cedex 13
country: France
facility: Höpital de la Pitié Salpêtrière
city: Paris
country: France
facility: Hospital Saint Louis
city: Paris
country: France
facility: Groupe Hospitalier Bichat Claude Bernard
city: Berlin
country: Germany
facility: zibp Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
city: Frankfurt
country: Germany
facility: Infektio Research GmbH & Co.KG
city: Hamburg
country: Germany
facility: ICH Study Center GmbH & Co. KG
city: München
country: Germany
facility: MVZ München am Goetheplatz
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena
city: Roma
country: Italy
facility: Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS
city: Torino
country: Italy
facility: ASL Città di Torino
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Tokyo
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
city: San Juan
country: Puerto Rico
facility: Hope Clinical Research
city: San Juan
country: Puerto Rico
facility: Proyecto ACTU
city: Cape Town
country: South Africa
facility: Desmond Tutu Health Foundation Clinical Trials Unit
city: Ga Rankuwa
country: South Africa
facility: Sefako Makgatho Health Sciences University
city: Johannesburg
country: South Africa
facility: Ezintsha
city: Barcelona
country: Spain
facility: Hospital Clinic Provincial de Barcelona
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal, Madrid
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taoyuan City
country: Taiwan
facility: Taoyuan General Hospital
city: Birmingham
country: United Kingdom
facility: Department of HIV & Sexual Medicine
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospitals NHS Trust
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: London
country: United Kingdom
facility: HIV medicine and infectious diseases
city: London
country: United Kingdom
facility: St.Stephen's AIDS Trust, Clinical Trials Unit, 1st Floor, St.Stephen's Centre
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: