Clinical trial NCT06630299: Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1
Official title: A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Standard of Care
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: 600
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 safety and efficacy of switching to a once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard of care treatment in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on a stable standard of care regimen for ≥ 6 months prior to screening. The standard of care includes 2 or 3 medicines, antiretroviral agents (ARVs).

The primary objective of the study is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing standard of care 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 weeks 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.
* Are receiving guideline-recommended standard of care treatment such as International Antiviral Society (IAS), Department of Health and Human Services (DHHS), European AIDS Clinical Society (EACS) consisting of 2 or 3 ARVs for ≥ 6 months prior to screening and willing to continue until Day 1. Individuals in Treatment Group 2 must also be willing to continue their standard of care through at least Week 96.
* 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 (ALT) \> 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 Week 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 Week 96 as Determined by the US FDA-defined Snapshot Algorithm
timeFrame: Week 96
measure: Change from Baseline in clusters of differentiation 4 (CD4) T-Cell Count at Week 48
timeFrame: Baseline, Week 48
measure: Change from Baseline in CD4 T-Cell Count at Week 96
timeFrame: Baseline, Week 96
measure: Proportion of Participants Discontinuing ISL/LEN due to Treatment-Emergent Adverse Events (TEAEs)
timeFrame: First dose date up to Week 96
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham(UAB) 1917 Research Clinic
state: Alabama
city: Phoenix
country: United States
facility: Pueblo Family Physicians
state: Arizona
city: Los Angeles
country: United States
facility: Vv-Tmf-5366229
state: California
city: Los Angeles
country: United States
facility: Ruane Clinical Research Group
state: California
city: Palm Springs
country: United States
facility: BIOS Clinical Research
state: California
city: Denver
country: United States
facility: Vivent Health
state: Colorado
city: Denver
country: United States
facility: University of Colorado Clinical and Translational Research Center
state: Colorado
city: New Haven
country: United States
facility: Yale University; School of Medicine; AIDS Program
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Aids Healthcare Foundation - Northpoint
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: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Pensacola
country: United States
facility: AHF Pensacola
state: Florida
city: Sarasota
country: United States
facility: CAN Community Health
state: Florida
city: Tampa
country: United States
facility: BayCare Health System, Inc./St. Joseph's Hospital
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Research Institute, P.A.
state: Florida
city: Decatur
country: United States
facility: Metro Infectious Disease Consultants, P.L.L.C.
state: Georgia
city: Macon
country: United States
facility: Mercer University, Department of Internal Medicine
state: Georgia
city: Savannah
country: United States
facility: Chatham County Health Department
state: Georgia
city: Chicago
country: United States
facility: Howard Brown Health Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana CTSI Clinical Research Center
state: Indiana
city: Boston
country: United States
facility: Brigham and Womens's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Community Research Initiative of New England d/b/a Community Resource Initiative (CRI)
state: Massachusetts
city: Berkley
country: United States
facility: Be Well Medical Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
city: Grand Rapids
country: United States
facility: Trinity Health Michigan d/b/a Trinity Health Grand Rapids Hospital
state: Michigan
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: Santa Fe
country: United States
facility: AXCES Research Group, LLC
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: Flushing
country: United States
facility: NewYork-Presbyterian Queens
state: New York
city: Manhasset
country: United States
facility: Northwell Health/Division of Infectious Diseases
state: New York
city: Durham
country: United States
facility: Duke University Health System(DUHS)
state: North Carolina
city: Greenville
country: United States
facility: ECU Health Leo Jenkins Cancer Building
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 College of Medicine
state: Ohio
city: Columbia
country: United States
facility: Prisma Health Midlands - Clinical Research Unit
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, 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: Longview
country: United States
facility: Clinical Alliance for Research& Education - Infectious Diseases, LLC (CARE-ID)
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
state: Virginia
city: Spokane
country: United States
facility: MultiCare Rockwood Main Clinic
state: Washington
city: Buenos Aires
country: Argentina
facility: Hospital General de Agudos Dr. J.M. Ramos Mejia
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 Clinic
state: Victoria
city: Hannover
country: Germany
facility: University Hospital Hannover, Department for Rheumatology and Immunology
city: Köln
country: Germany
facility: Dr. Scholten & Schneeweiß GbR
city: Mannheim
country: Germany
facility: Mannheimer Onkologie Praxis
city: Munchen
country: Germany
facility: MVZ München am Goetheplatz, MUC Research GmbH
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: Amsterdam
country: Netherlands
facility: Amsterdam UMC, Iocation AMC
city: Leiden
country: Netherlands
facility: Leiden University Medical Center (LUMC)
city: Szczecin
country: Poland
facility: Samodzielny Publiczny Wojewodzig Szpital Zespolony Poradnia Nabytych Niedoborow Immunologicznych
city: Wrocław
country: Poland
facility: Wroclawskie Centrum Zorowia Samodzielny Publiczn Zaklad Opieki Zdrowotnej Sp Zoo Osrodek Profilaktyczno-Leczniczy Chorob Zakaznych I Terapi Uzaleznien
city: San Juan
country: Puerto Rico
facility: HOPE Clinical Research
city: San Juan
country: Puerto Rico
facility: Maternal Infant Studies Center(CEMI)
city: Cape Town
country: South Africa
facility: Desmond Tutu Health Foundation, Clinical Trials Unit
city: Soweto
country: South Africa
facility: Perinatal HIV Research Unit
city: Barcelona
country: Spain
facility: Hospital Germans Trias I Pujol
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Bern
country: Switzerland
facility: Inselspital, Freiburgstrasse 20. Bern
city: Geneva
country: Switzerland
facility: Hopitaux Universitaires de Geneve
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung 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: Bangkok
country: Thailand
facility: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS Research
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Chiang Mai
country: Thailand
facility: Chiang Mai University
city: Khon Kaen
country: Thailand
facility: Khon Kaen University
city: Nonthaburi
country: Thailand
facility: Bamrasnaradura Infectious Disease Institute
city: Pathumwan
country: Thailand
facility: Institute of HIV Research and Innovation (IHRI)
city: Brighton
country: United Kingdom
facility: Clinical Research Facility -University Hospitals Sussex NHS Foundation Trust
city: Great Maze Pond
country: United Kingdom
facility: Harrison Wing Research Unit, Southwark Wing, Guy's Hospital (Guy's & St. Thomas' 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: Caldecot Centre, King's College Hospital (King's College 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: