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Cure My Disease

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Could a weekly pill replace daily HIV meds? new study aims to find out.

NCT ID NCT06630286

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether people with HIV who are already well-controlled on a daily pill (B/F/TAF) can safely switch to a once-weekly tablet (islatravir/lenacapavir). About 600 participants will take either the weekly pill or continue their daily regimen for 48 weeks. The goal is to see if the weekly option keeps the virus suppressed just as well, offering a more convenient treatment choice.

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

609 people

The number who actually took part.

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 week 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. * 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. 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 \> 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.

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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 (AIDS Healthcare Foundation) - Pensacola Research

    Pensacola, Florida, 32504, United States

  • AP-HP-Hopital Bicétre

    Le Kremlin-Bicêtre, 94270, France

  • AXCES Research Group - Albuquerque

    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

  • Assistance Publique Hopitaux de Marseille - Hopital Sainte Marguerite

    Marseile, 13009, France

  • Atrium Health Infectious Disease Kenilworth

    Charlotte, North Carolina, 28207, United States

  • BIOS Clinical Research

    Palm Springs, California, 92262, United States

  • Be Well Medical Center

    Berkley, Michigan, 48072, United States

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

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

    Greenville, North Carolina, 27858, United States

  • Brooklyn Clinical Research Center

    Brooklyn, New York, 11226, United States

  • CAN Community Health

    Fort Lauderdale, Florida, 33316, United States

  • CAN Community Health

    Miami Gardens, Florida, 33055, United States

  • CAN Community Health

    Sarasota, Florida, 34237, United States

  • CHU Bordeaux - Hopital Saint André

    Bourdeaux, 33075, France

  • CHU Nice - Hopital Archet I

    Nice, 6203, France

  • CTRC University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • Central Texas Clinical Research

    Austin, Texas, 78705, United States

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011, Switzerland

  • Chatham CARE Center

    Savannah, Georgia, 31401, United States

  • Chiba University Hospital

    Chiba, Japan

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

    Annandale, Virginia, 22003, United States

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

    Brighton, BN2 3EW, United Kingdom

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

    London, SW10 9TH, United Kingdom

  • Clinical Research Puerto Rico

    San Juan, PR, 00909, Puerto Rico

  • Clinique de médecine Urbaine du Quartier Latin

    Montreal, H2L 0B1, Canada

  • Community Research Initiative

    Boston, Massachusetts, 02129, United States

  • Complexo Hospitalario Universitario da Coruna

    A Coruña, 15006, Spain

  • DCOL Center for Clinical Research

    Longview, Texas, 75605, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • EPIMED GmbHGesellschaft fur klinische und epidemiologische Forschung in Berlin

    Berlin, 10787, Germany

  • East Sydney Doctors

    Darlinghurst, New South Wales, 2010, Australia

  • Emory University

    Atlanta, Georgia, 30308, United States

  • Far Eastern Memorial Hospital

    New Taipei City, 22060, Taiwan

  • Fundacion Huesped

    Buenos Aires, 1202, Argentina

  • Georgetown University

    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

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

    Birmingham, B9 5SS, United Kingdom

  • Helios Salud S.A.

    Buenos Aires, 1425, Argentina

  • Hospital Clinic Barcelona

    Barcelona, 08036, Spain

  • Hospital Universitario Regional de Malaga

    Málaga, 29010, Spain

  • Hospital Universitario Vall d' Hebron

    Barcelona, 08035, Spain

  • Howard Brown Health

    Chicago, Illinois, 60613, United States

  • ICH Study Center GmbH & Co.KG

    Hamburg, 20146, Germany

  • ID CARE

    Hillsborough, New Jersey, 08844, United States

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

  • Infectious Disease Specialists of Atlanta

    Decatur, Georgia, 30033, United States

  • Inselspital

    Bern, 3010, Switzerland

  • 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

  • KC CARE Health Center

    Kansas City, Missouri, 64111, United States

  • Kaiser Permanente Southern California

    Los Angeles, California, 90027, United States

  • Kaohsuing Medical University Hospital

    Kaohsiung City, 80756, Taiwan

  • Kaohsuing Veterans General Hospital

    Kaohsiung City, 81362, Taiwan

  • McGill University Health Centr

    Montreal, H4A 3J1, Canada

  • Mercer University

    Macon, Georgia, 31201, United States

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109, United States

  • Midland Research Group, Inc.

    Oakland Park, Florida, 33334, United States

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982, United States

  • Mills Clinical Research

    Los Angeles, California, 90069, 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 Institute for Research & Innovation

    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

  • New York Presbyterian Hospital

    Flushing, New York, 11355, United States

  • North Texas Infectious Diseases Consultants

    Dallas, Texas, 75246, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Optimus Medical Group

    San Francisco, California, 94102, United States

  • Orlando Immunology Center

    Orlando, Florida, 32803, United States

  • Osaka City General Hospital

    Osaka, 534-0021, Japan

  • Peter Shalit MD

    Seattle, Washington, 98104, United States

  • Prahran Market Private Clinic

    South Yarra, Victoria, 3141, Australia

  • Prisma Health/USC

    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, Inc

    Los Angeles, California, 90036, United States

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102, United States

  • South Jersey Infectious Disease

    Somers Point, New Jersey, 08244, United States

  • Spectrum Health

    Vancouver, V6Z 2T1, Canada

  • St Vincent's Hospital

    Darlinghurst, New South Wales, 2010, Australia

  • St. Josephs Comprehensive Research Institute

    Tampa, Florida, 33607, United States

  • 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 Brigham and Women's Hospital, Inc.

    Boston, Massachusetts, 02115, United States

  • The Crofoot Research Center, INC.

    Houston, Texas, 77098, United States

  • Tokyo Medical University Hospital

    Tokyo, 160-0023, Japan

  • Trinity Health

    Grand Rapids, Michigan, 49503, United States

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

    Cologne, 50924, Germany

  • Universitaetsspital Zuerich

    Zurich, 8091, Switzerland

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

    Essen, 45122, Germany

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

    Bonn, 53127, Germany

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Colorado- Anschutz Medical Campus - PPDS

    Denver, Colorado, 80262, United States

  • University of Puerto Rico School of Medicine

    San Juan, PR, 00935, Puerto Rico

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53705, United States

  • University of the Ryukyus Hospital

    Okinawa, Japan

  • Vivent Health

    Denver, Colorado, 80246, United States

  • Whitman-Walker Health

    Washington D.C., District of Columbia, 20009, United States

  • Yale University

    New Haven, Connecticut, 06510, United States

More trials for these conditions

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