Clinical trial NCT06630286: Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1
Official title: A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: HIV-1-infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2024-10-08
Enrollment: 609
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 about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard treatment of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on B/F/TAF for ≥ 6 months prior to screening.

The primary objective is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 48.


Eligibility criteria: Key Inclusion Criteria:

* HIV-1 RNA \< 50 copies/mL for ≥ 6 months before screening, as documented by:

  1. One HIV-1 RNA \< 50 copies/mL immediately preceding the 24 week period prior to screening.
  2. Within 24 weeks prior to screening, if HIV-1 RNA results are available, all levels must be \< 50 copies/mL.
  3. During the 6 to 12 months period prior to screening, transient detectable viremia ≥ 50 copies/mL is acceptable ("blip"), as long as it is not confirmed on 2 consecutive visits.
* Plasma HIV-1 RNA levels \< 50 copies/mL at screening.
* Individuals are receiving B/F/TAF for ≥ 6 months prior to screening and willing to continue until Day 1.
* Individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception.

Key Exclusion Criteria:

* Prior virologic failure.
* Prior use of, or exposure to ISL or LEN.
* Active, serious infections requiring parenteral therapy within 30 days before randomization.
* Active tuberculosis infection.
* Acute hepatitis within 30 days before randomization.
* Hepatitis B virus (HBV) infection as determined below at the screening visit:

  1. Positive HBV surface antigen OR
  2. Positive HBV core antibody and negative HBV surface antibody. Note: individuals found to be susceptible to HBV infection (eg negative hepatitis B surface antibody at the screening visit, regardless of prior HBV vaccination history) should be recommended to receive HBV vaccination.
* Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA. Note: individuals with prior/inactive HCV infection (defined as undetectable HCV RNA) may be enrolled.
* Any of the following laboratory values at screening:

  1. Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula
  2. Alanine aminotransferase \> 5 x upper limit of normal (ULN)
  3. Direct bilirubin \> 1.5 x ULN
  4. Platelets \< 50,000/μL
  5. Hemoglobin \< 8.0 g/dL

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 United States (US) Food and Drug Administration (FDA)-Defined Snapshot Algorithm
timeFrame: Week 48
Secondary outcomes:
measure: 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: Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Weeks 48 as Determined by the US FDA-Defined Snapshot Algorithm
timeFrame: Week 48
measure: Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Weeks 96 as Determined by the US FDA-Defined Snapshot Algorithm
timeFrame: Week 96
measure: Change From Baseline in Cluster of Differentiation 4 (CD4) T-Cell Count at Weeks 48
timeFrame: Week 48
measure: Change From Baseline in CD4 T-Cell Count at Weeks 96
timeFrame: Week 96
measure: Proportion of Participants Discontinuing ISL/LEN due to Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Day 1 up to Week 48
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Pueblo Family Physicians
state: Arizona
city: Los Angeles
country: United States
facility: Kaiser Permanente Southern California
state: California
city: Los Angeles
country: United States
facility: Ruane Clinical Research Group, Inc
state: California
city: Los Angeles
country: United States
facility: Mills Clinical Research
state: California
city: Palm Springs
country: United States
facility: BIOS Clinical Research
state: California
city: San Francisco
country: United States
facility: Optimus Medical Group
state: California
city: Denver
country: United States
facility: Vivent Health
state: Colorado
city: Denver
country: United States
facility: University of Colorado- Anschutz Medical Campus - PPDS
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Washington
country: United States
facility: Whitman-Walker Health
state: District of Columbia
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 Gardens
country: United States
facility: CAN Community Health
state: Florida
city: Oakland Park
country: United States
facility: Midland Research Group, Inc.
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Pensacola
country: United States
facility: AHF (AIDS Healthcare Foundation) - Pensacola Research
state: Florida
city: Sarasota
country: United States
facility: CAN Community Health
state: Florida
city: Tampa
country: United States
facility: St. Josephs Comprehensive Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Decatur
country: United States
facility: Infectious Disease Specialists of Atlanta
state: Georgia
city: Macon
country: United States
facility: Mercer University
state: Georgia
city: Savannah
country: United States
facility: Chatham CARE Center
state: Georgia
city: Chicago
country: United States
facility: Howard Brown Health
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Boston
country: United States
facility: The Brigham and Women's Hospital, Inc.
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Community Research Initiative
state: Massachusetts
city: Berkley
country: United States
facility: Be Well Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: Trinity Health
state: Michigan
city: Kansas City
country: United States
facility: KC CARE Health Center
state: Missouri
city: Hillsborough
country: United States
facility: ID CARE
state: New Jersey
city: Newark
country: United States
facility: Saint Michael's Medical 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 - Albuquerque
state: New Mexico
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: Brooklyn Clinical Research Center
state: New York
city: Flushing
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Chapel Hill
country: United States
facility: CTRC University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health Infectious Disease Kenilworth
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Greenville
country: United States
facility: Brody School of Medicine at East Carolina University Adult Specialty Care
state: North Carolina
city: Huntersville
country: United States
facility: Rosedale Health and Wellness
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Columbia
country: United States
facility: Prisma Health/USC
state: South Carolina
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: Dallas
country: United States
facility: North Texas Infectious Diseases Consultants
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: Longview
country: United States
facility: DCOL Center for Clinical Research
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: Spokane
country: United States
facility: MultiCare Institute for Research & Innovation
state: Washington
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Fundacion Huesped
city: Buenos Aires
country: Argentina
facility: Helios Salud S.A.
city: Darlinghurst
country: Australia
facility: East Sydney Doctors
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Surry Hills
country: Australia
facility: Taylor Square Private Clinic
state: New South Wales
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: South Yarra
country: Australia
facility: Prahran Market Private Clinic
state: Victoria
city: Montreal
country: Canada
facility: Clinique de médecine Urbaine du Quartier Latin
city: Montreal
country: Canada
facility: McGill University Health Centr
city: Vancouver
country: Canada
facility: Spectrum Health
city: Bourdeaux
country: France
facility: CHU Bordeaux - Hopital Saint André
city: Le Kremlin Bicetre
country: France
facility: AP-HP-Hopital Bicétre
city: Marseile
country: France
facility: Assistance Publique Hopitaux de Marseille - Hopital Sainte Marguerite
city: Nice
country: France
facility: CHU Nice - Hopital Archet I
city: Berlin
country: Germany
facility: EPIMED GmbHGesellschaft fur klinische und epidemiologische Forschung in Berlin
city: Bonn
country: Germany
facility: University Hospital Bonn, Medizinische und Poliklink I, Immunologische Studienambulanz
city: Essen
country: Germany
facility: Universitatsmedizin Essen, Universitatsklinikum Essen, Klinik Dermatologie, Venerologie und Allergologie,, HPSTD-Ambulanz
city: Hamburg
country: Germany
facility: ICH Study Center GmbH & Co.KG
city: Köln
country: Germany
facility: Uniklinik Kéin, Innere Medizin |, Klinisches Studienzentrum Infektiologle, Clinical Trials Unit for Infectious Diseases(CTU-ID), ISZ Geb. 80
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
city: Okinawa
country: Japan
facility: University of the Ryukyus Hospital
city: Osaka Fu
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Osaka-City
country: Japan
facility: Osaka City General Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Tokyo
country: Japan
facility: Japan Institute for Health Security National Center for Global Health and Medicine
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico School of Medicine
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d' Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: La Coruña
country: Spain
facility: Complexo Hospitalario Universitario da Coruna
city: Málaga
country: Spain
facility: Hospital Universitario Regional de Malaga
city: Bern
country: Switzerland
facility: Inselspital
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Zurich
country: Switzerland
facility: Universitaetsspital Zuerich
city: Kaohsiung
country: Taiwan
facility: Kaohsuing Medical University Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsuing Veterans General Hospital
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan City
country: Taiwan
facility: Taoyuan General Hospital
city: Birmingham
country: United Kingdom
facility: Hawthorn House, Birmingham Heartlands Hospital (University Hospitals Birmingham NHS Foundation Trust)
city: Brighton
country: United Kingdom
facility: Clinical Research Facility (University Hospitals Sussex NHS Foundation Trust)
city: London
country: United Kingdom
facility: Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital (Barts Health NHS Trust)
city: London
country: United Kingdom
facility: Royal Free Hospital (Royal Free London NHS Foundation Trust)
city: London
country: United Kingdom
facility: Clinical Research Facility, 1st Floor, St Stephen's Centre, Chelsea and Westminster Hospital (Chelsea and Westminster Hospital NHS Foundation Trust)
city: London
country: United Kingdom
facility: Mortimer Market Centre (Central and North West London NHS Foundation Trust)
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: