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New hope for hard-to-treat HIV: long-acting shot and pill combo tested

NCT ID NCT04150068

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests a new medicine called lenacapavir in people with HIV whose current drugs are no longer working due to multidrug resistance. The drug is given as a pill and an injection, and is added to their failing regimen for 14 days before switching to an optimized background regimen. The goal is to see if it can lower the amount of virus in the blood. 72 adults and adolescents are taking part.

What this could mean

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

Active substance
Lenacapavir (a long-acting capsid inhibitor, taken as pills and injections)
What this could lead to
If it works, this could provide a new, long-acting treatment option for people with HIV who have run out of effective medicines due to multidrug resistance.
What could go wrong
This is a mid-stage trial with only 72 participants, so results may not apply to everyone. The drug is added to a failing regimen initially, and long-term safety and effectiveness are still being studied.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

72 people

The number who actually took part.

Started

Nov 2019

Expected to finish

Jan 2027

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

12 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: * Adult aged ≥ 18 years (at all sites) or adolescent aged ≥ 12 and weighing ≥ 35 kg (at sites in North America and Dominican Republic) * Currently receiving a stable failing ARV regimen for \> 8 weeks * Have HIV-1 RNA ≥ 400 copies/mL at screening * Have multidrug resistance (resistance to ≥2 agents from ≥3 of the 4 main classes of ARV) * Have no more than 2 fully active ARV remaining from the 4 main classes that can be effectively combined to form a viable regimen * Able and willing to receive an OBR together with lenacapavir * No Hepatitis C virus (HCV) ongoing infection 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

  • 1265 Union Avenue, 8 East

    Memphis, Tennessee, 38163, United States

  • AIDS Arms, Inc. DBA Prism Health North Texas

    Dallas, Texas, 75215, United States

  • AIDS Healthcare Foundation - South Beach

    Miami Beach, Florida, 33139, United States

  • Atlanta ID Group, PC

    Atlanta, Georgia, 30309, United States

  • Atrium Health- Infectious Disease Consultants

    Charlotte, North Carolina, 28209, United States

  • Bamrasnaradura Infectious Diseases Institute

    Nonthaburi, 11000, Thailand

  • Be Well Medical Center

    Berkley, Michigan, 48072, United States

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

    Tokyo, 1628655, Japan

  • Central Texas Clinical Research

    Austin, Texas, 78705, United States

  • Chatham County Health Department

    Savannah, Georgia, 31401, United States

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

    Annandale, Virginia, 22003, United States

  • Clinique de médecine urbaine du Quartier Latin

    Montreal, Quebec, H2L 4E9, Canada

  • DCOL Center for Clinical Research

    Longview, Texas, 75605, United States

  • Divisione di Malattie Infettive, IRCCS Ospedale San Raffaele

    Milan, 20127, Italy

  • Durban International Clinical Research Site, Enhancing Care Foundation

    Durban, 4302, South Africa

  • Eisenhower Health Center at Rimrock

    Palm Springs, California, 92264, United States

  • Emory Hospital Midtown Infectious Disease Clinic

    Atlanta, Georgia, 30308, United States

  • Faculty of Medicine Ramathibodi Hospital, Mahidol University

    Bangkok, 10400, Thailand

  • Faculty of Medicine Siriraj Hospital, Mahidol University

    Bangkok, 10700, Thailand

  • Faculty of Medicine, Khon Kaen University

    Khon Kaen, 40002, Thailand

  • Far Eastern Memorial Hospital

    New Taipei City, 22060, Taiwan

  • Floridian Clinical Research

    Hialeah, Florida, 33016, United States

  • Gary J. Richmond, M.D., P.A.

    Fort Lauderdale, Florida, 33316, United States

  • Helen Joseph Hospital

    Johannesburg, 2092, South Africa

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Dr. Salvador Bienvenido Gautier

    Santo Domingo, 10514, Dominican Republic

  • Hospital Universitari Germans Trías i Pujol

    Badalona, 08916, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, 41013, Spain

  • Howard Brown Health Center

    Chicago, Illinois, 60613, United States

  • Hôpital Bichat-Claude Bernard

    Paris, 75018, France

  • Hôpital Saint-Antoine

    Paris, 75012, France

  • Hôpital Saint-Louis

    Paris, 75010, France

  • Hôpital Sainte-Marguerite

    Marseille, 13009, France

  • ICH Study Center GmbH & Co. KG

    Hamburg, 20146, Germany

  • Instituto Dominicano de Estudios Virologicos (IDEV)

    Santo Domingo, 10103, Dominican Republic

  • Jacobi Medical Center

    The Bronx, New York, 10461, United States

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362, Taiwan

  • Maple Leaf Research/Maple Leaf Medical Clinic

    Toronto, Ontario, M5G 1K2, Canada

  • Midland Florida Clinical Research Center, LLC

    DeLand, Florida, 32720, United States

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982, United States

  • Mills Clinical Research

    Los Angeles, California, 90069, United States

  • National Hospital Organization Nagoya Medical Center

    Nagoya, 460-0001, Japan

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006, Japan

  • National Taiwan University Hospital

    Taipei, 10048, Taiwan

  • New York-Presbyterian/Queens

    Flushing, New York, 11355, United States

  • North Shore University Hospital/Division of Infectious Diseases

    Manhasset, New York, 11030, United States

  • North Texas Infectious Diseases Consultants, P.A.

    Dallas, Texas, 75246, United States

  • Northstar Healthcare

    Chicago, Illinois, 60657, United States

  • One Community Health

    Sacramento, California, 95817, United States

  • Orlando Immunology Center

    Orlando, Florida, 32803, United States

  • Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Perinatal HIV Research Unit (PHRU)

    Soweto, 2013, South Africa

  • Ruane Clinical Research Group Inc

    Los Angeles, California, 90036, United States

  • Southampton Healthcare, Inc.

    St Louis, Missouri, 63139, United States

  • St Hope Foundation

    Bellaire, Texas, 77401, United States

  • St. Joseph's Hospital Comprehensive Research Institute

    Tampa, Florida, 33614, United States

  • Taoyuan General Hospital, Ministry of Health and Welfare

    Taoyuan City, 33004, Taiwan

  • Thai Red Cross AIDS Research Center

    Bangkok, 10330, Thailand

  • The Crofoot Research Center, INC.

    Houston, Texas, 77098, United States

  • The Miriam Hospital

    Providence, Rhode Island, 02906, United States

  • The Ottawa Hospital

    Ottawa, K1H 8L6, Canada

  • Tokyo Medical University Hospital

    Tokyo, 1600023, Japan

  • Triple O Research Institute, P.A.

    West Palm Beach, Florida, 33401, United States

  • U.O.C. IMMUNODEFICIENZE VIRALI - Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS

    Roma, 00149, Italy

  • U.O.C. Malattie Infettive - Fondazione Policlinico Universitario A. Gemelli IRCCS

    Rome, 00168, Italy

  • UOC Malattie Infettive - ASST Spedali Civili Di Brescia - Piazzale Spedali Civili 1

    Brescia, 25100, Italy

  • University of Naples Federico II

    Bergamo, 24127, Italy

  • Universitätsklinikum Essen, Klinik für Dermatologie und Venerologie

    Essen, 45122, Germany

  • Universitätsklinikum Frankfurt, Medizinische Klinik II

    Frankfurt am Main, Hesse, 60590, Germany

  • Vancouver ID Research and Care Centre Society

    Vancouver, British Columbia, V6Z 2C9, Canada

  • Vx Pharma

    Pretoria, 87, South Africa

  • Washington Health Institute

    Washington D.C., District of Columbia, 20017, United States

  • Yale University; School of Medicine

    New Haven, Connecticut, 06510, United States

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