Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Weekly HIV pill could replace daily doses

NCT ID NCT06630299

Disease control Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether a once-weekly pill (islatravir/lenacapavir) can keep HIV under control as well as daily standard care. About 600 people with HIV who already have undetectable virus levels will switch to the weekly pill or stay on their current daily regimen. The main goal is to see if the weekly pill prevents viral rebound at 48 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Islatravir and Lenacapavir (once-weekly pill)
What this could lead to
If successful, this could offer people with HIV a convenient once-weekly pill instead of daily medication, making it easier to stay suppressed.
What could go wrong
This is still an active trial; results are not yet known. The weekly pill may not work as well as daily regimens, and side effects could differ.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for HIV-1-infection are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV-1-infection

Contacts and locations

Locations

  • AHF Pensacola

    Pensacola, Florida, 32503, United States

  • AXCES Research Group, LLC

    Santa Fe, New Mexico, 87505, United States

  • AXCES Research Group, LLC

    El Paso, Texas, 79902, United States

  • AXCES Research Group, LLC

    Salt Lake City, Utah, 84102, United States

  • Aids Healthcare Foundation - Northpoint

    Fort Lauderdale, Florida, 33308, United States

  • Amsterdam UMC, Iocation AMC

    Amsterdam, 1105 az, Netherlands

  • BIOS Clinical Research

    Palm Springs, California, 92262, United States

  • Bamrasnaradura Infectious Disease Institute

    Nonthaburi, 11000, Thailand

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

    Tampa, Florida, 33607, United States

  • Be Well Medical Center

    Berkley, Michigan, 48072, United States

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • Brigham and Womens's Hospital

    Boston, Massachusetts, 02115, United States

  • CAN Community Health

    Miami Gardens, Florida, 33055, United States

  • CAN Community Health

    Sarasota, Florida, 34237, United States

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

    London, SE5 9RJ, United Kingdom

  • Central Texas Clinical Research

    Austin, Texas, 78705, United States

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011, Switzerland

  • Chatham County Health Department

    Savannah, Georgia, 31401, United States

  • Chiang Mai University

    Chiang Mai, 50200, Thailand

  • Chiba University Hospital

    Chiba, Japan

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

    Annandale, Virginia, 22003, United States

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

    Longview, Texas, 75605, United States

  • Clinical Research Facility -University Hospitals Sussex NHS Foundation Trust

    Brighton, BN2 3EW, United Kingdom

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

    Boston, Massachusetts, 02129, United States

  • Desmond Tutu Health Foundation, Clinical Trials Unit

    Cape Town, 7925, South Africa

  • Dr. Scholten & Schneeweiß GbR

    Cologne, 50674, Germany

  • Duke University Health System(DUHS)

    Durham, North Carolina, 27710, United States

  • ECU Health Leo Jenkins Cancer Building

    Greenville, North Carolina, 27834, United States

  • East Sydney Doctors

    Darlinghurst, New South Wales, 2010, Australia

  • Far Eastern Memorial Hospital

    New Taipei City, 22060, Taiwan

  • Fundacion Huesped

    Buenos Aires, 1202, Argentina

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007, United States

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

    London, E1 1BB., United Kingdom

  • HOPE Clinical Research

    San Juan, PR, 00909, Puerto Rico

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

    Great Maze Pond, SE1 3RR, United Kingdom

  • Helios Salud S.A.

    Buenos Aires, 1425, Argentina

  • Henry Ford Health

    Detroit, Michigan, 48202, United States

  • Hopitaux Universitaires de Geneve

    Geneva, 1205, Switzerland

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

    Buenos Aires, 1072, Argentina

  • Hospital Germans Trias I Pujol

    Barcelona, 08916, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Howard Brown Health Center

    Chicago, Illinois, 60613, United States

  • ID Care

    Hillsborough, New Jersey, 08844, United States

  • Indiana CTSI Clinical Research Center

    Indianapolis, Indiana, 46202, United States

  • Inselspital, Freiburgstrasse 20. Bern

    Bern, 3010, Switzerland

  • Institute of HIV Research and Innovation (IHRI)

    Pathumwan, 10330, Thailand

  • Jacobi Medical Center

    The Bronx, New York, 10461, United States

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

    Tokyo, 162-8655,, Japan

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 80756, Taiwan

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362, Taiwan

  • Khon Kaen University

    Khon Kaen, 40002, Thailand

  • Leiden University Medical Center (LUMC)

    Leiden, 2333 ZA, Netherlands

  • MVZ München am Goetheplatz, MUC Research GmbH

    München, 80337, Germany

  • Mannheimer Onkologie Praxis

    Mannheim, 68167, Germany

  • Maternal Infant Studies Center(CEMI)

    San Juan, 00936-5067, Puerto Rico

  • Mercer University, Department of Internal Medicine

    Macon, Georgia, 31201, United States

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

    Decatur, Georgia, 30033, United States

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982, United States

  • Monash Health

    Clayton, Victoria, 3168, Australia

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

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

    London, WC1E 6JB, United Kingdom

  • MultiCare Rockwood Main Clinic

    Spokane, Washington, 99202, United States

  • National Hospital Organization Nagoya Medical Center

    Nagoya, 460-0001, Japan

  • National Hospital Organization Osaka National Hospital

    Osaka Fu, 540-0006, Japan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • NewYork-Presbyterian Queens

    Flushing, New York, 11355, United States

  • North Texas Infectious Diseases Consultants, PA

    Dallas, Texas, 75246, United States

  • Northwell Health/Division of Infectious Diseases

    Manhasset, New York, 11030, United States

  • Orlando Immunology Center

    Orlando, Florida, 32803, United States

  • Osaka City General Hospital

    Osaka, 534-0021, Japan

  • Perinatal HIV Research Unit

    Soweto, 2013, South Africa

  • Prahran Market Clinic

    South Yarra, Victoria, 3141, Australia

  • Prisma Health Midlands - Clinical Research Unit

    Columbia, South Carolina, 29203, United States

  • Pueblo Family Physicians

    Phoenix, Arizona, 85015, United States

  • Rosedale Health and Wellness

    Huntersville, North Carolina, 28078, United States

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

    London, NW3 2QG, United Kingdom

  • Ruane Clinical Research Group

    Los Angeles, California, 90036, United States

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102, United States

  • Samodzielny Publiczny Wojewodzig Szpital Zespolony Poradnia Nabytych Niedoborow Immunologicznych

    Szczecin, 71-455, Poland

  • Siriraj Hospital

    Bangkok, 10700, Thailand

  • St Vincent's Hospital

    Darlinghurst, New South Wales, 2010, Australia

  • Taoyuan General Hospital

    Taoyuan City, 33004, Taiwan

  • Taylor Square Private Clinic

    Surry Hills, New South Wales, 2010, Australia

  • Texas Centers for Infectious Disease Associates

    Fort Worth, Texas, 76104, United States

  • The Crofoot Research Center, INC.

    Houston, Texas, 77098, United States

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

    Bangkok, 10330, Thailand

  • Tokyo Medical University Hospital

    Tokyo, 160-0023, Japan

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

    Grand Rapids, Michigan, 49503, United States

  • Triple O Research Institute, P.A.

    West Palm Beach, Florida, 33401, United States

  • University Hospital Hannover, Department for Rheumatology and Immunology

    Hanover, 30625, Germany

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

    Birmingham, Alabama, 35294, United States

  • University of Cincinnati College of Medicine

    Cincinnati, Ohio, 45267, United States

  • University of Colorado Clinical and Translational Research Center

    Denver, Colorado, 80262, United States

  • University of the Ryukyus Hospital

    Okinawa, Japan

  • Vivent Health

    Denver, Colorado, 80246, United States

  • Vv-Tmf-5366229

    Los Angeles, California, 90027, United States

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

    Wroclaw, 50-136, Poland

  • Yale University; School of Medicine; AIDS Program

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.