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HIV-1-InfectionPhase 3ISLEND-2NCT06630299

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1

A Phase 3 study testing ISL/LEN and Antiretroviral Combinations in people with HIV-1-Infection, run by Gilead Sciences at 100 sites in 14 countries.

Active, not recruiting

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

Official record
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Trial 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… 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 and Antiretroviral Combinations
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
100 sitesin 14 countries
Study dates
8 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 weeks 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.
  • 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.

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 (ALT) > 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

100 sites in 14 countries.

100 sites in 14 countries

United States49 sites

  • Clinical Alliance for Research& Education - Infectious Diseases, LLC

    Annandale, Virginia, 22003

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • Be Well Medical Center

    Berkley, Michigan, 48072

  • University of Alabama at Birmingham(UAB) 1917 Research Clinic

    Birmingham, Alabama, 35294

  • Brigham and Womens's Hospital

    Boston, Massachusetts, 02115

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Community Research Initiative of New England d/b/a Community Resource Initiative (CRI)

    Boston, Massachusetts, 02129

  • Howard Brown Health Center

    Chicago, Illinois, 60613

  • University of Cincinnati College of Medicine

    Cincinnati, Ohio, 45267

  • Prisma Health Midlands - Clinical Research Unit

    Columbia, South Carolina, 29203

  • North Texas Infectious Diseases Consultants, PA

    Dallas, Texas, 75246

  • Metro Infectious Disease Consultants, P.L.L.C.

    Decatur, Georgia, 30033

  • Vivent Health

    Denver, Colorado, 80246

  • University of Colorado Clinical and Translational Research Center

    Denver, Colorado, 80262

  • Henry Ford Health

    Detroit, Michigan, 48202

  • Duke University Health System(DUHS)

    Durham, North Carolina, 27710

  • AXCES Research Group, LLC

    El Paso, Texas, 79902

  • NewYork-Presbyterian Queens

    Flushing, New York, 11355

  • Aids Healthcare Foundation - Northpoint

    Fort Lauderdale, Florida, 33308

  • Texas Centers for Infectious Disease Associates

    Fort Worth, Texas, 76104

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982

  • Trinity Health Michigan d/b/a Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

  • ECU Health Leo Jenkins Cancer Building

    Greenville, North Carolina, 27834

  • ID Care

    Hillsborough, New Jersey, 08844

  • The Crofoot Research Center, INC.

    Houston, Texas, 77098

  • Rosedale Health and Wellness

    Huntersville, North Carolina, 28078

  • Indiana CTSI Clinical Research Center

    Indianapolis, Indiana, 46202

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

    Longview, Texas, 75605

  • Vv-Tmf-5366229

    Los Angeles, California, 90027

  • Ruane Clinical Research Group

    Los Angeles, California, 90036

  • Mercer University, Department of Internal Medicine

    Macon, Georgia, 31201

  • Northwell Health/Division of Infectious Diseases

    Manhasset, New York, 11030

  • CAN Community Health

    Miami Gardens, Florida, 33055

  • Yale University; School of Medicine; AIDS Program

    New Haven, Connecticut, 06510

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • BIOS Clinical Research

    Palm Springs, California, 92262

  • AHF Pensacola

    Pensacola, Florida, 32503

  • Pueblo Family Physicians

    Phoenix, Arizona, 85015

  • AXCES Research Group, LLC

    Salt Lake City, Utah, 84102

  • AXCES Research Group, LLC

    Santa Fe, New Mexico, 87505

  • CAN Community Health

    Sarasota, Florida, 34237

  • Chatham County Health Department

    Savannah, Georgia, 31401

  • MultiCare Rockwood Main Clinic

    Spokane, Washington, 99202

  • BayCare Health System, Inc./St. Joseph's Hospital

    Tampa, Florida, 33607

  • Jacobi Medical Center

    The Bronx, New York, 10461

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Triple O Research Institute, P.A.

    West Palm Beach, Florida, 33401

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

Thailand6 sites

  • The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS Research

    Bangkok, 10330

  • Siriraj Hospital

    Bangkok, 10700

  • Chiang Mai University

    Chiang Mai, 50200

  • Khon Kaen University

    Khon Kaen, 40002

  • Bamrasnaradura Infectious Disease Institute

    Nonthaburi, 11000

  • Institute of HIV Research and Innovation (IHRI)

    Pathumwan, 10330

Other trials in Thailand

United Kingdom6 sites

  • Clinical Research Facility -University Hospitals Sussex NHS Foundation Trust

    Brighton, BN2 3EW

  • Harrison Wing Research Unit, Southwark Wing, Guy's Hospital (Guy's & St. Thomas' NHS Foundation Trust)

    Great Maze Pond, SE1 3RR

  • 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

  • Caldecot Centre, King's College Hospital (King's College Hospital NHS Foundation Trust)

    London, SE5 9RJ

  • 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 Clinic

    South Yarra, Victoria, 3141

  • Taylor Square Private Clinic

    Surry Hills, New South Wales, 2010

Other trials in Australia

Taiwan5 sites

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 80756

  • Kaohsiung 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

Germany4 sites

  • Dr. Scholten & Schneeweiß GbR

    Cologne, 50674

  • University Hospital Hannover, Department for Rheumatology and Immunology

    Hanover, 30625

  • Mannheimer Onkologie Praxis

    Mannheim, 68167

  • MVZ München am Goetheplatz, MUC Research GmbH

    München, 80337

Other trials in Germany

Spain4 sites

  • Hospital Germans Trias I Pujol

    Barcelona, 08916

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

Other trials in Spain

Argentina3 sites

  • Hospital General de Agudos Dr. J.M. Ramos Mejia

    Buenos Aires, 1072

  • Fundacion Huesped

    Buenos Aires, 1202

  • Helios Salud S.A.

    Buenos Aires, 1425

Other trials in Argentina

Switzerland3 sites

  • Inselspital, Freiburgstrasse 20. Bern

    Bern, 3010

  • Hopitaux Universitaires de Geneve

    Geneva, 1205

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011

Other trials in Switzerland

Netherlands2 sites

  • Amsterdam UMC, Iocation AMC

    Amsterdam, 1105 az

  • Leiden University Medical Center (LUMC)

    Leiden, 2333 ZA

Other trials in Netherlands

Poland2 sites

  • Samodzielny Publiczny Wojewodzig Szpital Zespolony Poradnia Nabytych Niedoborow Immunologicznych

    Szczecin, 71-455

  • Wroclawskie Centrum Zorowia Samodzielny Publiczn Zaklad Opieki Zdrowotnej Sp Zoo Osrodek Profilaktyczno-Leczniczy Chorob Zakaznych I Terapi Uzaleznien

    Wroclaw, 50-136

Other trials in Poland

Puerto Rico2 sites

  • HOPE Clinical Research

    San Juan, PR, 00909

  • Maternal Infant Studies Center(CEMI)

    San Juan, 00936-5067

Other trials in Puerto Rico

South Africa2 sites

  • Desmond Tutu Health Foundation, Clinical Trials Unit

    Cape Town, 7925

  • Perinatal HIV Research Unit

    Soweto, 2013

Other trials in South Africa

About this study

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

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.

Conditions
HIV-1-Infection
Being tested
ISL/LEN, Antiretroviral Combinations

What participants receive

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

  • ISL/LENDrug

    Tablet administered orally

  • Antiretroviral CombinationsDrug

    2 or 3 antiretrovirals (ARVs) administered as defined by the investigator, according to the prescribing information.

Study groups in NCT06630299
Study groupRoleWhat they receive
ISL/LENExperimentalParticipants 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.
Receives: Drug: ISL/LEN
Standard of Care TreatmentActive comparatorParticipants 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)
Receives: Drug: ISL/LEN; Drug: Antiretroviral Combinations
Extension PhaseExperimentalAt 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.
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 Week 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 Week 96 as Determined by the US FDA-defined Snapshot Algorithm

    Measured: Week 96

  4. Change from Baseline in clusters of differentiation 4 (CD4) T-Cell Count at Week 48

    Measured: Baseline, Week 48

  5. Change from Baseline in CD4 T-Cell Count at Week 96

    Measured: Baseline, Week 96

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

    Measured: First dose date up to Week 96

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 start8 Oct 2024
  3. Primary completion23 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
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06630299
Sponsor's protocol ID
GS-US-563-5926
Other IDs
2024-514047-28
Acronym
ISLEND-2
Status last verified
May 2026
First submitted
4 Oct 2024
Last updated
29 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Colson AE, Kumar PN, Ruane PJ, Chetchotisakd P, Ratanasuwan W, Liberty A, Nahass RG, Arenas-Pinto A, Post FA, Baker DA, Cahn P, Hofmann E, Watanabe D, Lu PL, Roukens AHE, Parczewski M, Wang H, Chen K, Shihadeh F, Shaughnessy M, Dvory-Sobol H, SenGupta D, Llamoso C, Rhee M, Ogbuagu O; ISLEND-2 Study Team. Switch to once-weekly, single-tablet islatravir-lenacapavir from daily standard of care for HIV-1 (ISLEND-2): a multicentre, randomised, open-label, active-controlled, phase 3 non-inferiority trial. Lancet. 2026 Aug 12:S0140-6736(26)01442-X. doi: 10.1016/S0140-6736(26)01442-X. Online ahead of print.

    PubMed 42586113

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ISL/LEN and Antiretroviral Combinations in people with HIV-1-Infection, run by Gilead Sciences at 100 sites in 14 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 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 sites in United States, Japan, Thailand, United Kingdom, Australia and 9 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 NCT06630299, 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 29 May 2026.

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