Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1
NCT ID: NCT06630299
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
600 participants
INTERVENTIONAL
2024-10-08
2030-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ISL/LEN
Participants will receive an initial dose of ISL/LEN (Dose A), followed by once weekly ISL/LEN (Dose B) from Day 8 onwards up to Week 96.
ISL/LEN
Tablet administered orally
Standard of Care Treatment
Participants will continue standard of care treatment with 2-3 ARVs up to Week 96:
* Integrase Strand Transfer Inhibitor (INSTI) class: INSTI combined with 1 or 2 nucleoside reverse transcriptase inhibitors (NRTIs; bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; coformulated; Biktarvy®), dolutegravir (DTG)/abacavir (ABC)/lamivudine (3TC), DTG+ TAF or TDF (TXF)/emtricitabine (FTC; Emtriva®), DTG/tenofovir disoproxil fumarate (TDF; Viread®)/3TC, DTG/3TC, raltegravir (RAL) + TXF/FTC, RAL+TDF/3TC, elvitegravir (EVG; Vitekta®)/cobicistat (c; Tybost®)/TXF/FTC), or
* PI class: Boosted protease inhibitor (PI) combined with 2 NRTIs (darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF; coformulated), boosted darunavir (DRV)+TXF/FTC, boosted DRV+TDF/3TC), or
* NNRTI class: Nonnucleoside reverse transcriptase inhibitor (NNRTI) combined with 2 NRTIs (doravirine (DOR)/TDF/3TC, DOR+TXF/FTC, DOR+TDF/3TC, rilpivirine (RPV)/TXF/FTC, RPV+TXF/FTC, RPV+TDF/3TC)
ISL/LEN
Tablet administered orally
Antiretroviral Combinations
2 or 3 antiretrovirals (ARVs) administered as defined by the investigator, according to the prescribing information.
Extension Phase
At the end of randomized treatment visit, if safety and efficacy of ISL/LEN are demonstrated following review of randomized data, participants will be given the option to receive ISL/LEN tablets in an extension phase until ISL/LEN becomes available or until the sponsor elects to discontinue the study, whichever occurs first.
Participants receiving ISL/LEN during the randomized phase will continue to take ISL/LEN weekly.
Participants receiving standard of care during the randomized phase will take an initial dose of ISL/LEN (Dose A), followed by once weekly ISL/LEN (Dose B) from Day 8 onwards.
ISL/LEN
Tablet administered orally
Interventions
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ISL/LEN
Tablet administered orally
Antiretroviral Combinations
2 or 3 antiretrovirals (ARVs) administered as defined by the investigator, according to the prescribing information.
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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University of Alabama at Birmingham(UAB) 1917 Research Clinic
Birmingham, Alabama, United States
Pueblo Family Physicians
Phoenix, Arizona, United States
Vv-Tmf-5366229
Los Angeles, California, United States
Ruane Clinical Research Group
Los Angeles, California, United States
BIOS Clinical Research
Palm Springs, California, United States
Vivent Health
Denver, Colorado, United States
University of Colorado Clinical and Translational Research Center
Denver, Colorado, United States
Yale University; School of Medicine; AIDS Program
New Haven, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Aids Healthcare Foundation - Northpoint
Fort Lauderdale, Florida, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
CAN Community Health
Miami Gardens, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
AHF Pensacola
Pensacola, Florida, United States
CAN Community Health
Sarasota, Florida, United States
BayCare Health System, Inc./St. Joseph's Hospital
Tampa, Florida, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States
Metro Infectious Disease Consultants, P.L.L.C.
Decatur, Georgia, United States
Mercer University, Department of Internal Medicine
Macon, Georgia, United States
Chatham County Health Department
Savannah, Georgia, United States
Howard Brown Health Center
Chicago, Illinois, United States
Indiana CTSI Clinical Research Center
Indianapolis, Indiana, United States
Brigham and Womens's Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Community Research Initiative of New England d/b/a Community Resource Initiative (CRI)
Boston, Massachusetts, United States
Be Well Medical Center
Berkley, Michigan, United States
Henry Ford Health
Detroit, Michigan, United States
Trinity Health Michigan d/b/a Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, United States
ID Care
Hillsborough, New Jersey, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
AXCES Research Group, LLC
Santa Fe, New Mexico, United States
NewYork-Presbyterian Queens
Flushing, New York, United States
Northwell Health/Division of Infectious Diseases
Manhasset, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University Health System(DUHS)
Durham, North Carolina, United States
ECU Health Leo Jenkins Cancer Building
Greenville, North Carolina, United States
Rosedale Health and Wellness
Huntersville, North Carolina, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
Prisma Health Midlands - Clinical Research Unit
Columbia, South Carolina, United States
Central Texas Clinical Research
Austin, Texas, United States
North Texas Infectious Diseases Consultants, PA
Dallas, Texas, United States
AXCES Research Group, LLC
El Paso, Texas, United States
Texas Centers for Infectious Disease Associates
Fort Worth, Texas, United States
The Crofoot Research Center, INC.
Houston, Texas, United States
Clinical Alliance for Research& Education - Infectious Diseases, LLC (CARE-ID)
Longview, Texas, United States
AXCES Research Group, LLC
Salt Lake City, Utah, United States
Clinical Alliance for Research& Education - Infectious Diseases, LLC
Annandale, Virginia, United States
MultiCare Rockwood Main Clinic
Spokane, Washington, United States
Hospital General de Agudos Dr. J.M. Ramos Mejia
Buenos Aires, , Argentina
Fundacion Huesped
Buenos Aires, , Argentina
Helios Salud S.A.
Buenos Aires, , Argentina
East Sydney Doctors
Darlinghurst, New South Wales, Australia
St Vincent's Hospital
Darlinghurst, New South Wales, Australia
Taylor Square Private Clinic
Surry Hills, New South Wales, Australia
Monash Health
Clayton, Victoria, Australia
Prahran Market Clinic
South Yarra, Victoria, Australia
Dr. Scholten & Schneeweiß GbR
Cologne, , Germany
University Hospital Hannover, Department for Rheumatology and Immunology
Hanover, , Germany
Mannheimer Onkologie Praxis
Mannheim, , Germany
MVZ München am Goetheplatz, MUC Research GmbH
München, , Germany
Chiba University Hospital
Chiba, , Japan
National Hospital Organization Nagoya Medical Center
Nagoya, , Japan
University of the Ryukyus Hospital
Okinawa, , Japan
Osaka City General Hospital
Osaka, , Japan
National Hospital Organization Osaka National Hospital
Osaka Fu, , Japan
Tokyo Medical University Hospital
Tokyo, , Japan
Japan Institute for Health Security National Center for Global Health and Medicine
Tokyo, , Japan
Amsterdam UMC, Iocation AMC
Amsterdam, , Netherlands
Leiden University Medical Center (LUMC)
Leiden, , Netherlands
Samodzielny Publiczny Wojewodzig Szpital Zespolony Poradnia Nabytych Niedoborow Immunologicznych
Szczecin, , Poland
Wroclawskie Centrum Zorowia Samodzielny Publiczn Zaklad Opieki Zdrowotnej Sp Zoo Osrodek Profilaktyczno-Leczniczy Chorob Zakaznych I Terapi Uzaleznien
Wroclaw, , Poland
HOPE Clinical Research
San Juan, PR, Puerto Rico
Maternal Infant Studies Center(CEMI)
San Juan, , Puerto Rico
Desmond Tutu Health Foundation, Clinical Trials Unit
Cape Town, , South Africa
Perinatal HIV Research Unit
Soweto, , South Africa
Hospital Germans Trias I Pujol
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Inselspital, Freiburgstrasse 20. Bern
Bern, , Switzerland
Hopitaux Universitaires de Geneve
Geneva, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Kaohsiung Medical University Hospital
Kaohsiung City, , Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taoyuan General Hospital
Taoyuan, , Taiwan
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS Research
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Chiang Mai University
Chiang Mai, , Thailand
Khon Kaen University
Khon Kaen, , Thailand
Bamrasnaradura Infectious Disease Institute
Nonthaburi, , Thailand
Institute of HIV Research and Innovation (IHRI)
Pathumwan, , Thailand
Clinical Research Facility -University Hospitals Sussex NHS Foundation Trust
Brighton, , United Kingdom
Harrison Wing Research Unit, Southwark Wing, Guy's Hospital (Guy's & St. Thomas' NHS Foundation Trust)
Great Maze Pond, , United Kingdom
Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital (Barts Health NHS Trust)
London, , United Kingdom
Royal Free Hospital (Royal Free London NHS Foundation Trust)
London, , United Kingdom
Caldecot Centre, King's College Hospital (King's College Hospital NHS Foundation Trust)
London, , United Kingdom
Mortimer Market Centre (Central and North West London NHS Foundation Trust)
London, , United Kingdom
Countries
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Related Links
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Gilead Clinical Trials Website
Other Identifiers
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GS-US-563-5926
Identifier Type: -
Identifier Source: org_study_id
2024-514047-28
Identifier Type: OTHER
Identifier Source: secondary_id