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Could a simpler HIV pill work just as well? new study compares 2-drug combo to standard 3-drug therapy.

NCT ID NCT06333808

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 switching to a new 2-drug combination pill (bictegravir/lenacapavir) is as safe and effective as staying on the standard 3-drug pill (Biktarvy) for people with HIV-1 whose virus is already suppressed. About 577 participants who have been on Biktarvy for at least 6 months will be randomly assigned to either the new 2-drug pill or continue Biktarvy. The main goal is to see if the new pill keeps the virus under control at 48 weeks.

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

577 people

The number who actually took part.

Started

Mar 2024

Expected to finish

Dec 2029

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: * Currently receiving B/F/TAF for at least 6 months prior to screening. * If plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) measurements in the last 6 months prior to screening are available, all levels must be \< 50 copies/mL. * At least one documented HIV-1 RNA level measured between 6 and 12 months (± 2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be \< 50 copies/mL. * Plasma HIV-1 RNA levels \< 50 copies/mL at screening. * No documented or suspected resistance to BIC (including integrase strand-transfer inhibitor resistant (INSTI-R) mutations T66A/I/K, E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene). * No documented or suspected resistance to tenofovir alafenamide (TAF) (TAF; mutations K65R, K65N, K70E, Q151M or T69 insertion, or ≥ 3 of the following thymidine analog mutations \[M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R\] in the reverse transcriptase gene). * Estimated glomerular filtration rate ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance. Key Exclusion Criteria: * Positive serum pregnancy test or pregnant at screening or a positive pregnancy test prior to Day 1 randomization. * Breastfeeding (nursing). * Prior use of, or exposure to, LEN. * Active, serious infections (other than HIV-1) requiring parenteral therapy \< 30 days prior to randomization. * Active tuberculosis infection. * Acute hepatitis \< 30 days before randomization. * Chronic hepatitis B virus (HBV) infection, as determined by either: * Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit. * Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit. * Known hypersensitivity to the study drug, its metabolites, or any formulation excipient. * History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding). * Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as determined by the investigator. * Active malignancy requiring acute systemic therapy. * Any of the following laboratory values at screening: * Alanine aminotransferase \> 5 × upper limit of normal (ULN). * Direct bilirubin \> 1.5 × ULN. * Platelets \< 50,000/mm\^3. * Hemoglobin \< 8.0 g/dL. * Requirement for ongoing therapy with or prior use of any prohibited medications listed in the protocol. * Participation or planned participation in any other clinical study (including observational studies) without prior approval from the sponsor. * Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements. 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 Pensacola

    Pensacola, Florida, 32503, United States

  • AIDS Arms, Inc. DBA Prism Health North Texas

    Dallas, Texas, 75208, United States

  • AIDS Healthcare Foundation - The Kinder Medical Group

    Miami, Florida, 33133, United States

  • ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN

    Brescia, 25123, Italy

  • 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

  • Alfred Hospital(Alfred Health)

    Melbourne, Victoria, 3004, Australia

  • Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care

    Oakland, California, 94609, United States

  • Azienda Ospedaliero Universitaria Ospedali Riuniti (Policlinico di Foggia)

    Foggia, 71122, Italy

  • BIOS Clinical Research

    Palm Springs, California, 92262, United States

  • Be Well Medical Center

    Berkeley, California, 48072, United States

  • Bliss Healthcare

    Orlando, Florida, 32806, United States

  • CAN Community Health

    Fort Lauderdale, Florida, 33316, United States

  • CAN community Health

    Sarasota, Florida, 34237, United States

  • Center Hospital of the National Center for Global Health and Medicine

    Tokyo, 162-0052, Japan

  • Central Texas Clinical Research

    Austin, Texas, 78705, United States

  • Chelsea and Westminster Hospital NHS Foundation Trust, St Stephen's Centre, Chelsea and Westminster Hospital

    London, SW109NH, United Kingdom

  • Chronic Viral Illness Service/McGill University Health Centre (MUHC)

    Decarie Montreal, H4A 3J1, Canada

  • Claudia T Martorell MD LLC dba The Research Institute

    Springfield, Massachusetts, 01105, United States

  • Clinical Alliance For Research & Education - Infectious Diseases. LLC (CARE-ID)

    Annandale, Virginia, 22003, United States

  • Clinique Médicale l'Actuel

    Montreal, H2L 4P9, Canada

  • Community Health care

    Tacoma, Washington, 98405, United States

  • Consorcio Hospital General Universitario de Valencia

    Valencia, 46014, Spain

  • Cool Aid Community Health Centre

    Victoria, V8W 1M8, Canada

  • Floridian Clinical Research

    Miami Lakes, Florida, 33016, United States

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    Pavia, 27100, Italy

  • Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo

    Monza, 20090, Italy

  • Fondazione Policlinico Universitario A Gemelli-Rome

    Roma, 00168, Italy

  • Fundacion Huesped

    Buenos Aires, C1202ABB, Argentina

  • HOPE Clinical Research

    San Juan, PR, 00909, Puerto Rico

  • Helios Salud S.A.

    Buenos Aires, C1141ACG, Argentina

  • Henry Ford Health

    Detroit, Michigan, 48202, United States

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Universitario Germans Trias i Pujol

    Badalona Barcelona, 8916, Spain

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen del Rocio - PPDS

    Seville, 4103, Spain

  • ID Care, LLC

    Hillsborough, New Jersey, 08844, United States

  • IRCCS Ospedale San Raffaele

    Milan, 20127, Italy

  • Infectious Disease Specialists of Atlanta

    Decatur, Georgia, 30033, United States

  • Instituto CAICI SRL

    Santa Fe, S2000PBJ,, Argentina

  • Instituto Dominicano de Estudios Virologicos - IDEV

    Santo Domingo, Dominican Republic

  • Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS

    Roma, 00149, Italy

  • KC Care health Center

    Kansas City, Missouri, 64111, United States

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362, Taiwan

  • King's College Hospital, Weston Education Centre

    London, SE5 9RS, United Kingdom

  • Klinikum rechts der Isar der Technischen Universitaet Muenchen

    München, 81675, Germany

  • Kyungpook National University Hospital

    Daegu, 41944, South Korea

  • LMU Klinikum der Universität

    Munich, 80336, Germany

  • Liverpool University Hospitals NHS Foundation Trust, Royal Liverpool Hospital

    Liverpool, L7 8XP, United Kingdom

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California, 90502, United States

  • Medical University of South Carolina (MUSC) Research Nexus

    Charleston, South Carolina, 29425, United States

  • Mercer University, Department of Internal Medicine

    Macon, Georgia, 31201, United States

  • Midland Florida Infectious Diseases Specialists, PL - Orange City

    DeLand, Florida, 32720, United States

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982, United States

  • Mills Clinical Research

    West Hollywood, California, 90046, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Mortimer Market Centre

    London, WC1E 6JB, United Kingdom

  • National Hospital Organization Nagoya Medical Center

    Aichi, 460-0001, Japan

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006, Japan

  • National Medical Center

    Seoul, *04564, South Korea

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • New Jersey Medical School - Clinical Research Center

    Newark, New Jersey, 07103, United States

  • New York-Presbyterian Queens

    Flushing, New York, 11355, United States

  • North Texas Infectious Diseases Consultants, PA

    Dallas, Texas, 75246, United States

  • Novopraxis Berlin

    Berlin, 10117, Germany

  • Orlando Immunology Center

    Orlando, Florida, 32803, United States

  • Pacific Oaks Medical Group

    Beverly Hills, California, 90211, United States

  • Peter Shalit MD

    Seattle, Washington, 98104, United States

  • Philadelphia FIGHT Community Health Centers

    Philadelphia, Pennsylvania, 19107, United States

  • Prahran Market Clinic

    South Yarra, Victoria, 3141, Australia

  • Praxis Dr. Knechten

    Aachen, 52062, Germany

  • Praxis am Ebertplatz

    Cologne, 50668, Germany

  • ProcliniQ Investigacion Clinica Toriello Guerra, Tlalpan

    Mexico City, 6170, Mexico

  • Proyecto ACTU

    San Juan, PR, 00935, Puerto Rico

  • Public Health Institute at Denver Health

    Denver, Colorado, 80204, United States

  • Pueblo Family Physicians

    Phoenix, Arizona, 85015, United States

  • Regina General Hospital

    Regina, S4P 0W5, Canada

  • Rosedale Health and Wellness

    Huntersville, North Carolina, 28078, United States

  • Ruane Clinical Research Group Inc.

    Los Angeles, California, 90036, United States

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102, United States

  • Schiff Center for liver Diseases/University of Miami

    Miami, Florida, 33136, United States

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • South Jersey Infectious Disease

    Somers Point, New Jersey, 08244, United States

  • Southampton Community Healthcare, Inc.

    St Louis, Missouri, 63139, United States

  • St Hope Foundation, Inc.

    Bellaire, Texas, 77401, United States

  • St Mary's Hospital - PPDS

    London, W2 1NY, United Kingdom

  • St. Paul's Hospital, John Ruedy Clinic-Immunodeficiency Clinic (JRC-IDC)

    Vancouver, V6Z1Y6, Canada

  • Taoyuan General Hospital, Ministry of Health and Welfare

    Taoyuan City, 33004, Taiwan

  • Taylor Square Private Clinic

    Darlinghurst, New South Wales, 2011, Australia

  • Texas Centers for Infectious Disease Associates

    Fort Worth, Texas, 76104, United States

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

    Greenville, North Carolina, 27858, United States

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 137-701, South Korea

  • The Crofoot research Center, INC.

    Houston, Texas, 77098, United States

  • The Ottawa Hospital - General Campus

    Ottawa, K1H 8L6, Canada

  • Therafirst Medical Center

    Fort Lauderdale, Florida, 33308, United States

  • Triple O Research Institute, P.A.

    West Palm Beach, Florida, 33407, United States

  • UCSD Anti Viral Research Centre (AVRC)

    San Diego, California, 92103, United States

  • Unidad de Atencion Medica e Investigacion en Salud

    Mérida, 97070, Mexico

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590, Germany

  • Universitätsklinikum Hamburg Eppendorf

    Hamburg, 20246, Germany

  • Yale University School of Medicine (study visits)

    New Haven, Connecticut, 06510, United States

More trials for these conditions

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