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New daily HIV pill shows promise in landmark trial

NCT ID NCT04233879

Disease control Sponsor: Merck Sharp & Dohme LLC 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new once-daily combination pill (doravirine/islatravir) in 599 adults newly diagnosed with HIV-1 who had never taken HIV medication. The goal was to see if the new pill works as well as a standard three-drug regimen at keeping the virus under control. Results showed the new pill effectively suppressed HIV levels with a similar safety profile, offering a simpler treatment option.

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

599 people

The number who actually took part.

Started

Feb 2020

Finished

Jan 2025

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.

Inclusion Criteria: * Is human immunodeficiency virus type 1 (HIV-1) positive * Is naïve to antiretroviral therapy (ART) defined as having received ≤10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection including prevention of mother-to-child transmission up to 1 month prior to screening. * A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: 1) Is not a woman of childbearing potential (WOCBP); 2) Is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis); 3) A WOCBP must have a negative highly sensitive pregnancy test (\[urine or serum\] as required by local regulations) within 24 hours before the first dose of study intervention; 4) If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required Exclusion Criteria: * Has human immunodeficiency virus type 2 (HIV-2) infection * Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator * Has an active diagnosis of hepatitis due to any cause, including active hepatitis B virus (HBV) infection (defined as hepatitis B surface antigen \[HBsAg\]-positive or hepatitis B virus deoxyribonucleic acid \[HBV DNA\]-positive) * Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma * Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study * Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1 * Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapy from 45 days prior to Day 1 through the study intervention period * Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study intervention period * Has a documented or known virologic resistance to any approved HIV-1 reverse transcriptase inhibitor, or any study intervention * Has exclusionary laboratory values within 45 days prior to Day 1 * Is female and is expecting to conceive or donate eggs at any time during the study

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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

  • A.O.R.N. dei Colli - Ospedale Cotugno ( Site 6407)

    Naples, Campania, 80131, Italy

  • A.P.H. Paris, Hopital Saint Louis ( Site 6114)

    Paris, 75010, France

  • A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 6124)

    Paris, Ain, 75018, France

  • ASST Fatebenefratelli-Ospedale Sacco ( Site 6400)

    Milan, 20157, Italy

  • ASST Papa Giovanni XXIII ( Site 6411)

    Bergamo, Lombardy, 24127, Italy

  • Azienda Ospedaliera San Paolo ( Site 6403)

    Milan, 20142, Italy

  • Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 6404)

    Modena, Emilia-Romagna, 41124, Italy

  • Azienda USL di Pescara-Presidio Ospedaliero di Pescara ( Site 6413)

    Pescara, 65129, Italy

  • Be Part Yoluntu Centre ( Site 6603)

    Mbekweni, Paarl, Western Cape, 7646, South Africa

  • CAN Community Health ( Site 5627)

    Sarasota, Florida, 34237, United States

  • CHU de Bordeaux. Hopital Pellegrin ( Site 6116)

    Bordeaux, Gironde, 33076, France

  • Center Hospital of the National Center for Global Health and Medicine ( Site 6901)

    Tokyo, 162-8655, Japan

  • Centre Hospitalier Regional du Orleans ( Site 6108)

    Orléans, Centre-Val de Loire, 45000, France

  • Centre Hospitalier de Tourcoing ( Site 6100)

    Tourcoing, Nord, 59208, France

  • Centro Cardiovascular Cardiosur ( Site 5907)

    Santiago, Region M. de Santiago, 8910259, Chile

  • Chaim Sheba Medical Center. ( Site 6704)

    Ramat Gan, 5265601, Israel

  • Chris Hani Baragwanath Hospital - ICU ( Site 6608)

    Johannesburg, Gauteng, 1862, South Africa

  • Clinica Arauco Salud ( Site 5900)

    Santiago, Region M. de Santiago, 7560994, Chile

  • Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 6006)

    Bogotá, Bogota D.C., 111321, Colombia

  • Clinica Universidad Catolica del Maule ( Site 5909)

    Talca, Maule Region, 3460000, Chile

  • Clinique Medicale L Actuel ( Site 5714)

    Montreal, Quebec, H2L 4P9, Canada

  • Columbus Regional Research Institute ( Site 5616)

    Columbus, Georgia, 31904, United States

  • Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 6613)

    Cape Town, Western Cape, 7925, South Africa

  • EPIMED- Ges. f. epidemiolog. u. klin. Forschung in der Medizin mbH ( Site 6208)

    Berlin, 10787, Germany

  • Ezintsha ( Site 6609)

    Johannesburg, Gauteng, 2193, South Africa

  • Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6617)

    Cape Town, Western Cape, 7500, South Africa

  • Floridian Clinical Research, LLC ( Site 5625)

    Miami Lakes, Florida, 33016, United States

  • Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 6401)

    Milan, 20122, Italy

  • Fundacion Arriaran ( Site 5901)

    Santiago, Region M. de Santiago, 8360159, Chile

  • Fundacion Valle del Lili ( Site 6001)

    Cali, Valle del Cauca Department, 760032, Colombia

  • Fundación Huesped ( Site 5801)

    C.a.b.a, Buenos Aires F.D., C1202ABB, Argentina

  • Hadassah Ein Kerem Medical Center ( Site 6702)

    Jerusalem, 9112001, Israel

  • Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 5703)

    Hamilton, Ontario, L8S 14K, Canada

  • Helios Salud S.A. ( Site 5802)

    Buenos Aires, Buenos Aires F.D., C1141ACG, Argentina

  • Hennepin Healthcare-Hennepin Healthcare-ID ( Site 5633)

    Minneapolis, Minnesota, 55415, United States

  • Hopital Avicenne ( Site 6102)

    Bobigny, Seine-Saint-Denis, 93000, France

  • Hopital Francois Mitterrand ( Site 6119)

    Dijon, Cote-d Or, 21079, France

  • Hopital Pitie Salpetriere ( Site 6111)

    Paris, 75013, France

  • Hopital Saint-Antoine ( Site 6113)

    Paris, 75012, France

  • Hopital de la Croix-Rousse ( Site 6127)

    Lyon, Auvergne-Rhône-Alpes, 69004, France

  • Hospital Clinic i Provincial ( Site 6300)

    Barcelona, Catalonia, 08036, Spain

  • Hospital Clinico de la Universidad Catolica ( Site 5903)

    Santiago, Region M. de Santiago, 8331150, Chile

  • Hospital Dr. Hernan Henriquez Aravena ( Site 5905)

    Temuco, Araucania, 4781151, Chile

  • Hospital General Universitario Gregorio Maranon ( Site 6303)

    Madrid, 28007, Spain

  • Hospital General de Elche ( Site 6308)

    Elche, Alicante, 03202, Spain

  • Hospital Universitari Germans Trias i Pujol ( Site 6301)

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitari de Bellvitge ( Site 6312)

    LHospitalet de Llobregat, Barcelona, 08907, Spain

  • Hospital Universitario 12 de Octubre ( Site 6305)

    Madrid, 28041, Spain

  • Hospital Universitario Fundacion Jimenez Diaz ( Site 6307)

    Madrid, 28040, Spain

  • Hospital Universitario La Paz ( Site 6304)

    Madrid, 28046, Spain

  • Hospital Universitario San Ignacio ( Site 6005)

    Bogotá, Bogota D.C., 110231, Colombia

  • Hospital Universitario Virgen de la Victoria ( Site 6309)

    Málaga, 29010, Spain

  • Hospital Vall D Hebron ( Site 6302)

    Barcelona, Catalonia, 08035, Spain

  • IDEAA Foundation ( Site 5807)

    Buenos Aires, Buenos Aires F.D., C1405CKC, Argentina

  • IRCCS Policlinico San Matteo ( Site 6410)

    Pavia, 27100, Italy

  • Infectious Disease Specialists Of Atlanta PC ( Site 5608)

    Decatur, Georgia, 30033, United States

  • Infektiologikum ( Site 6201)

    Frankfurt am Main, Hesse, 60596, Germany

  • Instituto CAICI ( Site 5803)

    Rosario, Santa Fe Province, S2000PBJ, Argentina

  • Instituto Oulton ( Site 5804)

    Córdoba, X5000JJS, Argentina

  • Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 6405)

    Roma, 00149, Italy

  • JOSHA Research ( Site 6605)

    Bloemfontein, Free State, 9301, South Africa

  • Kansas City CARE Clinic ( Site 5607)

    Kansas City, Missouri, 64111, United States

  • Kaohsiung Veterans General Hospital ( Site 7102)

    Kaohsiung City, 81362, Taiwan

  • Kaplan Medical Center ( Site 6700)

    Rehovot, 7610001, Israel

  • Klinikum der LMU München ( Site 6204)

    Munich, Bavaria, 80336, Germany

  • Kumamoto University Hospital ( Site 6905)

    Kumamoto, 860-8556, Japan

  • MVZ Munchen am Goetheplatz ( Site 6202)

    Munich, Bavaria, 80337, Germany

  • McGill University Health Center - Research Institute-CVIS Clinical Research Unit ( Site 5702)

    Montreal, Quebec, H4A 3J1, Canada

  • Midway Immunology and Research ( Site 5622)

    Ft. Pierce, Florida, 34982, United States

  • National Cheng Kung University Hospital ( Site 7101)

    Tainan, 70403, Taiwan

  • National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 69

    Osaka, 540-0006, Japan

  • National Hospital Organization Nagoya Medical Center ( Site 6903)

    Nagoya, Aichi-ken, 460-0001, Japan

  • National Taiwan University Hospital ( Site 7100)

    Taipei, 100, Taiwan

  • North Texas ID Consultants, PA ( Site 5604)

    Dallas, Texas, 75246, United States

  • Orlando Immunology Center ( Site 5613)

    Orlando, Florida, 32803, United States

  • Ospedale Amedeo di Savoia ( Site 6414)

    Turin, Piedmont, 10149, Italy

  • Ospedale San Gerardo ASST Monza ( Site 6412)

    Monza, Monza E Brianza, 20900, Italy

  • Pueblo Family Physicians ( Site 5606)

    Phoenix, Arizona, 85015, United States

  • Rambam Medical Center ( Site 6701)

    Haifa, 3109601, Israel

  • Ruane Clinical Research Group, Inc. ( Site 5624)

    Los Angeles, California, 90036, United States

  • Saint Hope Foundation, Inc. ( Site 5629)

    Bellaire, Texas, 77401, United States

  • Salute San Raffaele ( Site 6402)

    Milan, 20127, Italy

  • Sourasky Medical Center ( Site 6705)

    Tel Aviv, 64239, Israel

  • Texas Centers for Infectious Disease Associates P.A. ( Site 5619)

    Fort Worth, Texas, 76104, United States

  • The Kinder Medical Group ( Site 5615)

    Miami, Florida, 33133, United States

  • Tokyo Medical University Hospital ( Site 6904)

    Tokyo, 160-0023, Japan

  • Toronto General Hospital - University Health Network ( Site 5705)

    Toronto, Ontario, M5G 2N2, Canada

  • Triple O Research Institute, P.A. ( Site 5621)

    West Palm Beach, Florida, 33407, United States

  • Universitaetsklinik Freiburg ( Site 6206)

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Universitaetsklinikum Bonn ( Site 6200)

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 6210)

    Hamburg, 20246, Germany

  • University of Alabama at Birmingham 1917 Research Clinic ( Site 5610)

    Birmingham, Alabama, 35222, United States

  • University of Pennsylvania ( Site 5630)

    Philadelphia, Pennsylvania, 19104, United States

  • Wentworth Hospital ( Site 6607)

    Durban, KwaZulu-Natal, 4052, South Africa

  • Wits Health Consortium. Clinical HIV Research Unit ( Site 6614)

    Johannesburg, Gauteng, 2041, South Africa

More trials for these conditions

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