Clinical trial NCT06333808: Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: HIV-1-infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2024-03-27
Enrollment: 577
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized in parallel in one of two treatment groups during the Blinded Phase. Participants in both treatment groups will be given the option to continue BIC/LEN FDC treatment during the Open-Label Phase.
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)/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.


Eligibility criteria: Key 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.

Key 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.

Primary outcomes:
measure: 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: 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: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 48
timeFrame: Baseline; Week 48
measure: Treatment Group 1: Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm
timeFrame: Week 96
measure: Treatment Group 1: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 96 as Determined by US FDA-defined Snapshot Algorithm
timeFrame: Week 96
measure: Treatment Group 1: Change from Baseline in CD4 Cell Count at Week 96
timeFrame: Baseline; Week 96
measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) through Week 48
timeFrame: From first dose date up to Week 48
measure: Treatment Group 1: Percentage of Participants Experiencing Treatment-Emergent AEs through Week 96
timeFrame: From first dose date up to Week 96
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pueblo Family Physicians
state: Arizona
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: UCSD Anti Viral Research Centre (AVRC)
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: Mills Clinical Research
state: California
city: Denver
country: United States
facility: Public Health Institute at Denver Health
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine (study visits)
state: Connecticut
city: DeLand
country: United States
facility: Midland Florida Infectious Diseases Specialists, PL - Orange City
state: Florida
city: Fort Lauderdale
country: United States
facility: Therafirst Medical Center
state: Florida
city: Fort Lauderdale
country: United States
facility: CAN Community Health
state: Florida
city: Fort Pierce
country: United States
facility: Midway Immunology and Research Center
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Clinical Research
state: Florida
city: Miami
country: United States
facility: AIDS Healthcare Foundation - The Kinder Medical Group
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: Bliss Healthcare
state: Florida
city: Pensacola
country: United States
facility: AHF Pensacola
state: Florida
city: Sarasota
country: United States
facility: CAN community Health
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Research Institute, P.A.
state: Florida
city: Decatur
country: United States
facility: Infectious Disease Specialists of Atlanta
state: Georgia
city: Macon
country: United States
facility: Mercer University, Department of Internal Medicine
state: Georgia
city: Springfield
country: United States
facility: Claudia T Martorell MD LLC dba The Research Institute
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
city: Kansas City
country: United States
facility: KC Care health Center
state: Missouri
city: Saint Louis
country: United States
facility: Southampton Community Healthcare, Inc.
state: Missouri
city: Hillsborough
country: United States
facility: ID Care, LLC
state: New Jersey
city: Newark
country: United States
facility: Saint Michael's Medical Center
state: New Jersey
city: Newark
country: United States
facility: New Jersey Medical School - Clinical Research Center
state: New Jersey
city: Somers Point
country: United States
facility: South Jersey Infectious Disease
state: New Jersey
city: Santa Fe
country: United States
facility: AXCES Research Group, LLC
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Flushing
country: United States
facility: New York-Presbyterian Queens
state: New York
city: Greenville
country: United States
facility: The Brody School of Medicine at East Carolina University , ECU Adult Specialty Care
state: North Carolina
city: Huntersville
country: United States
facility: Rosedale Health and Wellness
state: North Carolina
city: Philadelphia
country: United States
facility: Philadelphia FIGHT Community Health Centers
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, Inc.
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, PA
state: Texas
city: El Paso
country: United States
facility: AXCES Research Group, LLC
state: Texas
city: Fort Worth
country: United States
facility: Texas Centers for Infectious Disease Associates
state: Texas
city: Houston
country: United States
facility: The Crofoot research Center, INC.
state: Texas
city: Salt Lake City
country: United States
facility: AXCES Research Group, LLC
state: Utah
city: Annandale
country: United States
facility: Clinical Alliance For Research & Education - Infectious Diseases. LLC (CARE-ID)
state: Virginia
city: Seattle
country: United States
facility: Peter Shalit MD
state: Washington
city: Tacoma
country: United States
facility: Community Health care
state: Washington
city: Buenos Aires
country: Argentina
facility: Helios Salud S.A.
city: Buenos Aires
country: Argentina
facility: Fundacion Huesped
city: Santa Fe
country: Argentina
facility: Instituto CAICI SRL
city: Darlinghurst
country: Australia
facility: Taylor Square Private Clinic
state: New South Wales
city: Melbourne
country: Australia
facility: Alfred Hospital(Alfred Health)
state: Victoria
city: South Yarra
country: Australia
facility: Prahran Market Clinic
state: Victoria
city: Decarie Montreal
country: Canada
facility: Chronic Viral Illness Service/McGill University Health Centre (MUHC)
city: Montreal
country: Canada
facility: Clinique Médicale l'Actuel
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
city: Regina
country: Canada
facility: Regina General Hospital
city: Vancouver
country: Canada
facility: St. Paul's Hospital, John Ruedy Clinic-Immunodeficiency Clinic (JRC-IDC)
city: Victoria
country: Canada
facility: Cool Aid Community Health Centre
city: Santo Domingo
country: Dominican Republic
facility: Instituto Dominicano de Estudios Virologicos - IDEV
city: Aachen
country: Germany
facility: Praxis Dr. Knechten
city: Berlin
country: Germany
facility: Novopraxis Berlin
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg Eppendorf
city: Köln
country: Germany
facility: Praxis am Ebertplatz
city: Munchen
country: Germany
facility: Klinikum rechts der Isar der Technischen Universitaet Muenchen
city: Munich
country: Germany
facility: LMU Klinikum der Universität
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
city: Foggia
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti (Policlinico di Foggia)
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo di Pavia
city: Roma
country: Italy
facility: Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli-Rome
city: Aichi
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: Seoul
country: Korea, Republic of
facility: National Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Merida
country: Mexico
facility: Unidad de Atencion Medica e Investigacion en Salud
city: Mexico City
country: Mexico
facility: ProcliniQ Investigacion Clinica Toriello Guerra, Tlalpan
city: San Juan
country: Puerto Rico
facility: HOPE Clinical Research
city: San Juan
country: Puerto Rico
facility: Proyecto ACTU
city: Badalona Barcelona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz - PPDS
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio - PPDS
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan City
country: Taiwan
facility: Taoyuan General Hospital, Ministry of Health and Welfare
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals NHS Foundation Trust, Royal Liverpool Hospital
city: London
country: United Kingdom
facility: King's College Hospital, Weston Education Centre
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation Trust, St Stephen's Centre, Chelsea and Westminster Hospital
city: London
country: United Kingdom
facility: St Mary's Hospital - PPDS
city: London
country: United Kingdom
facility: Mortimer Market Centre
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: