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AzTrials

HIV-1-infectionPhase 3ISLEND-1NCT06630286

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1

A Phase 3 study testing ISL/LEN, B/F/TAF and PTM B/F/TAF in people with HIV-1-infection, run by Gilead Sciences at 106 sites in 12 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV-1-infection
What is being tested?
ISL/LEN, B/F/TAF and PTM B/F/TAF
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
609 participants
Where
106 sitesin 12 countries
Study dates
9 Oct 2024to Aug 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HIV-1 RNA < 50 copies/mL for ≥ 6 months before screening, as documented by:
  • One HIV-1 RNA < 50 copies/mL immediately preceding the 24 week period prior to screening.
  • Within 24 weeks prior to screening, if HIV-1 RNA results are available, all levels must be < 50 copies/mL.
  • 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.

Who cannot join

  • 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:
Show all 16Show fewer
  • Positive HBV surface antigen OR
  • 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:
  • Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula
  • Alanine aminotransferase > 5 x upper limit of normal (ULN)
  • Direct bilirubin > 1.5 x ULN
  • Platelets < 50,000/μL
  • Hemoglobin < 8.0 g/dL
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

106 sites in 12 countries.

106 sites in 12 countries

United States60 sites

  • Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)

    Annandale, Virginia, 22003

  • Emory University

    Atlanta, Georgia, 30308

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • Be Well Medical Center

    Berkley, Michigan, 48072

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • The Brigham and Women's Hospital, Inc.

    Boston, Massachusetts, 02115

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Community Research Initiative

    Boston, Massachusetts, 02129

  • Brooklyn Clinical Research Center

    Brooklyn, New York, 11226

  • CTRC University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Atrium Health Infectious Disease Kenilworth

    Charlotte, North Carolina, 28207

  • Howard Brown Health

    Chicago, Illinois, 60613

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Prisma Health/USC

    Columbia, South Carolina, 29203

  • Ohio State University

    Columbus, Ohio, 43210

  • North Texas Infectious Diseases Consultants

    Dallas, Texas, 75246

  • Infectious Disease Specialists of Atlanta

    Decatur, Georgia, 30033

  • Vivent Health

    Denver, Colorado, 80246

  • University of Colorado- Anschutz Medical Campus - PPDS

    Denver, Colorado, 80262

  • Duke University

    Durham, North Carolina, 27710

  • AXCES Research Group, LLC

    El Paso, Texas, 79902

  • New York Presbyterian Hospital

    Flushing, New York, 11355

  • CAN Community Health

    Fort Lauderdale, Florida, 33316

  • Texas Centers for Infectious Disease Associates

    Fort Worth, Texas, 76104

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982

  • Trinity Health

    Grand Rapids, Michigan, 49503

  • Brody School of Medicine at East Carolina University Adult Specialty Care

    Greenville, North Carolina, 27858

  • ID CARE

    Hillsborough, New Jersey, 08844

  • The Crofoot Research Center, INC.

    Houston, Texas, 77098

  • Rosedale Health and Wellness

    Huntersville, North Carolina, 28078

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • KC CARE Health Center

    Kansas City, Missouri, 64111

  • DCOL Center for Clinical Research

    Longview, Texas, 75605

  • Kaiser Permanente Southern California

    Los Angeles, California, 90027

  • Ruane Clinical Research Group, Inc

    Los Angeles, California, 90036

  • Mills Clinical Research

    Los Angeles, California, 90069

  • Mercer University

    Macon, Georgia, 31201

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53705

  • CAN Community Health

    Miami Gardens, Florida, 33055

  • Yale University

    New Haven, Connecticut, 06510

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102

  • Midland Research Group, Inc.

    Oakland Park, Florida, 33334

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • BIOS Clinical Research

    Palm Springs, California, 92262

  • AHF (AIDS Healthcare Foundation) - Pensacola Research

    Pensacola, Florida, 32504

  • Pueblo Family Physicians

    Phoenix, Arizona, 85015

  • AXCES Research Group, LLC

    Salt Lake City, Utah, 84102

  • Optimus Medical Group

    San Francisco, California, 94102

  • AXCES Research Group - Albuquerque

    Santa Fe, New Mexico, 87505

  • CAN Community Health

    Sarasota, Florida, 34237

  • Chatham CARE Center

    Savannah, Georgia, 31401

  • Peter Shalit MD

    Seattle, Washington, 98104

  • South Jersey Infectious Disease

    Somers Point, New Jersey, 08244

  • MultiCare Institute for Research & Innovation

    Spokane, Washington, 99202

  • St. Josephs Comprehensive Research Institute

    Tampa, Florida, 33607

  • Jacobi Medical Center

    The Bronx, New York, 10461

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Georgetown University

    Washington D.C., District of Columbia, 20007

  • Whitman-Walker Health

    Washington D.C., District of Columbia, 20009

Other trials in United States

Japan7 sites

  • Chiba University Hospital

    Chiba

  • National Hospital Organization Nagoya Medical Center

    Nagoya, 460-0001

  • University of the Ryukyus Hospital

    Okinawa

  • Osaka City General Hospital

    Osaka, 534-0021

  • National Hospital Organization Osaka National Hospital

    Osaka Fu, 540-0006

  • Tokyo Medical University Hospital

    Tokyo, 160-0023

  • Japan Institute for Health Security National Center for Global Health and Medicine

    Tokyo, 162-8655,

Other trials in Japan

United Kingdom6 sites

  • Hawthorn House, Birmingham Heartlands Hospital (University Hospitals Birmingham NHS Foundation Trust)

    Birmingham, B9 5SS

  • Clinical Research Facility (University Hospitals Sussex NHS Foundation Trust)

    Brighton, BN2 3EW

  • Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital (Barts Health NHS Trust)

    London, E1 1BB.

  • Royal Free Hospital (Royal Free London NHS Foundation Trust)

    London, NW3 2QG

  • Clinical Research Facility, 1st Floor, St Stephen's Centre, Chelsea and Westminster Hospital (Chelsea and Westminster Hospital NHS Foundation Trust)

    London, SW10 9TH

  • Mortimer Market Centre (Central and North West London NHS Foundation Trust)

    London, WC1E 6JB

Other trials in United Kingdom

Australia5 sites

  • Monash Health

    Clayton, Victoria, 3168

  • East Sydney Doctors

    Darlinghurst, New South Wales, 2010

  • St Vincent's Hospital

    Darlinghurst, New South Wales, 2010

  • Prahran Market Private Clinic

    South Yarra, Victoria, 3141

  • Taylor Square Private Clinic

    Surry Hills, New South Wales, 2010

Other trials in Australia

Germany5 sites

  • EPIMED GmbHGesellschaft fur klinische und epidemiologische Forschung in Berlin

    Berlin, 10787

  • University Hospital Bonn, Medizinische und Poliklink I, Immunologische Studienambulanz

    Bonn, 53127

  • Uniklinik Kéin, Innere Medizin |, Klinisches Studienzentrum Infektiologle, Clinical Trials Unit for Infectious Diseases(CTU-ID), ISZ Geb. 80

    Cologne, 50924

  • Universitatsmedizin Essen, Universitatsklinikum Essen, Klinik Dermatologie, Venerologie und Allergologie,, HPSTD-Ambulanz

    Essen, 45122

  • ICH Study Center GmbH & Co.KG

    Hamburg, 20146

Other trials in Germany

Taiwan5 sites

  • Kaohsuing Medical University Hospital

    Kaohsiung City, 80756

  • Kaohsuing Veterans General Hospital

    Kaohsiung City, 81362

  • Far Eastern Memorial Hospital

    New Taipei City, 22060

  • National Taiwan University Hospital

    Taipei, 10002

  • Taoyuan General Hospital

    Taoyuan City, 33004

Other trials in Taiwan

France4 sites

  • CHU Bordeaux - Hopital Saint André

    Bourdeaux, 33075

  • AP-HP-Hopital Bicétre

    Le Kremlin-Bicêtre, 94270

  • Assistance Publique Hopitaux de Marseille - Hopital Sainte Marguerite

    Marseile, 13009

  • CHU Nice - Hopital Archet I

    Nice, 6203

Other trials in France

Spain4 sites

  • Complexo Hospitalario Universitario da Coruna

    A Coruña, 15006

  • Hospital Universitario Vall d' Hebron

    Barcelona, 08035

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Hospital Universitario Regional de Malaga

    Málaga, 29010

Other trials in Spain

Canada3 sites

  • Clinique de médecine Urbaine du Quartier Latin

    Montreal, H2L 0B1

  • McGill University Health Centr

    Montreal, H4A 3J1

  • Spectrum Health

    Vancouver, V6Z 2T1

Other trials in Canada

Switzerland3 sites

  • Inselspital

    Bern, 3010

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011

  • Universitaetsspital Zuerich

    Zurich, 8091

Other trials in Switzerland

Argentina2 sites

  • Fundacion Huesped

    Buenos Aires, 1202

  • Helios Salud S.A.

    Buenos Aires, 1425

Other trials in Argentina

Puerto Rico2 sites

  • Clinical Research Puerto Rico

    San Juan, PR, 00909

  • University of Puerto Rico School of Medicine

    San Juan, PR, 00935

Other trials in Puerto Rico

About this study

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)

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.

Conditions
HIV-1-infection
Being tested
ISL/LEN, B/F/TAF, PTM B/F/TAF, PTM ISL/LEN

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ISL/LENDrug

    Tablet administered orally

  • B/F/TAFDrug

    Also called Biktarvy®

    Tablet administered orally

  • PTM B/F/TAFDrug

    Tablet administered orally

  • PTM ISL/LENDrug

    Tablet administered orally

Study groups in NCT06630286
Study groupRoleWhat they receive
Blinded Phase: ISL/LEN + Placebo-to-Match (PTM) B/F/TAFExperimentalParticipants 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. Participants will also receive PTM B/F/TAF once daily from Day 1 up to Week 96.
Receives: Drug: ISL/LEN; Drug: PTM B/F/TAF
Blinded Phase: PTM ISL/LEN + B/F/TAFExperimentalParticipants will receive an initial dose of PTM ISL/LEN (Dose A), followed by once weekly PTM ISL/LEN (Dose B) from Day 8 onwards up to Week 96. Participants will also receive B/F/TAF (50/200/25 mg) once daily up from Day 1 up to Week 96.
Receives: Drug: B/F/TAF; Drug: PTM ISL/LEN
Open- Label Extension (OLE) PhaseExperimentalAfter the end of Blinded Phase at Week 96, if safety and efficacy of ISL/LEN are demonstrated following review of unblinded data, all participants will be given an option to enter the open-label extension phase to receive ISL/LEN 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 and PTM B/F/TAF during the blinded phase will continue to take ISL/LEN weekly. Participants receiving B/F/TAF and PTM ISL/LEN during the blinded phase will take an initial dose of ISL/LEN (Dose A), followed by once weekly ISL/LEN (Dose B) from Day 8 onwards.
Receives: Drug: ISL/LEN

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Week 48

Secondary outcomes (6)

  1. Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the US FDA-Defined Snapshot Algorithm

    Measured: Week 96

  2. Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Weeks 48 as Determined by the US FDA-Defined Snapshot Algorithm

    Measured: Week 48

  3. Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Weeks 96 as Determined by the US FDA-Defined Snapshot Algorithm

    Measured: Week 96

  4. Change From Baseline in Cluster of Differentiation 4 (CD4) T-Cell Count at Weeks 48

    Measured: Week 48

  5. Change From Baseline in CD4 T-Cell Count at Weeks 96

    Measured: Week 96

  6. Proportion of Participants Discontinuing ISL/LEN due to Treatment-Emergent Adverse Events (TEAEs)

    Measured: Day 1 up to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start9 Oct 2024
  3. Primary completion17 Apr 2026
  4. Study completionAug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
609 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06630286
Sponsor's protocol ID
GS-US-563-5925
Other IDs
2024-514046-37
Acronym
ISLEND-1
Status last verified
Apr 2026
First submitted
4 Oct 2024
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rockstroh JK, Ramgopal MN, Curran Fabregas A, Hedgcock M, Workowski KA, Ronot-Bregigeon S, Cassetti I, Brinson C, Gupta SK, Hung CC, O'Reilly M, Slim J, Gatanaga H, Shalit P, Liu SY, Klopfer SO, Shihadeh F, Patel N, Mercier RC, Shaughnessy M, Dvory-Sobol H, SenGupta D, Llamoso C, Rhee MS, Orkin C; ISLEND-1 Study Team. Phase 3 Trial of Weekly Oral Islatravir-Lenacapavir for HIV-1 Treatment. N Engl J Med. 2026 Jul 29. doi: 10.1056/NEJMoa2607973. Online ahead of print.

    PubMed 42525925

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ISL/LEN, B/F/TAF and PTM B/F/TAF in people with HIV-1-infection, run by Gilead Sciences at 106 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, Japan, United Kingdom, Australia, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06630286, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

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