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

New HIV pill shows promise in phase 3 trial

NCT ID NCT05705349

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new once-daily pill (doravirine/islatravir) for adults with HIV who have never taken HIV medication before. About 537 participants will receive either the new pill or a standard combination pill to see how well they control the virus and if they cause side effects. The main goal is to check if the new pill is as good as the standard treatment at keeping HIV levels very low after 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

537 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Aug 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

Accepted

You do not need to have the condition being studied to take part.

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 HIV-1 positive with plasma HIV-1 RNA ≥500 copies/mL at screening * Is naïve to antiretroviral therapy (ART) defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection * If female, is not a participant of childbearing potential (POCBP); or if a POCBP, is not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration Exclusion Criteria: * Has HIV-2 infection * Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator * Has a diagnosis of an active AIDS-defining opportunistic infection within 30 days prior to screening * Has active hepatitis B infection (defined as hepatitis B surface antigen \[HBsAg\]-positive or HBV deoxyribonucleic acid \[DNA\]-positive). * Has chronic hepatitis C virus (HCV) infection (detectable HCV ribonucleic acid \[RNA\]) and lab values are consistent with cirrhosis * Has a history of malignancy ≤5 years prior to providing documented 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, such that it is not in the best interest of the participant to participate

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 South Beach ( Site 5663)

    Miami Beach, Florida, 33140, United States

  • AHF The Kinder Medical Group ( Site 5672)

    Miami, Florida, 33133, United States

  • AXCES Research - Texas - El Paso ( Site 5692)

    El Paso, Texas, 79902, United States

  • Ankara Bilkent Şehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 7659)

    Ankara, 06800, Turkey (Türkiye)

  • Atlanta I.D. Group ( Site 5680)

    Atlanta, Georgia, 30309, United States

  • Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 5675)

    Charlotte, North Carolina, 28204, United States

  • Be Part Yoluntu Centre ( Site 6650)

    Paarl, Western Cape, 7626, South Africa

  • Be Well Medical Center ( Site 5650)

    Berkley, Michigan, 48072, United States

  • Biomedica Research Group-Infectology ( Site 5951)

    Santiago, Region M. de Santiago, 7500710, Chile

  • CAN Community Health - Sarasota ( Site 5668)

    Sarasota, Florida, 34237, United States

  • CCR KEMRI (Center for Clinical Research) ( Site 8652)

    Nairobi, Nairobi City, 00200, Kenya

  • CELAN,S.A ( Site 8351)

    Guatemala City, 01010, Guatemala

  • CLINIPHARM ( Site 8352)

    Guatemala City, 01001, Guatemala

  • Center Hospital of the National Center for Global Health and Medicine ( Site 6951)

    Shinjyuku-ku, Tokyo, 162-8655, Japan

  • Central Texas Clinical Research ( Site 5661)

    Austin, Texas, 78705, United States

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 6153)

    Nice, Alpes-Maritimes, 06202, France

  • Centro de Investigacion Clinicadela Universidad Catolica ( Site 5953)

    Santiago, Region M. de Santiago, 8330034, Chile

  • Ciensalud Ips S A S ( Site 6050)

    Barranquilla, Atlántico, 08001, Colombia

  • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 6051)

    Bogotá, Bogota D.C., 111321, Colombia

  • Clinica Universidad Catolica del Maule ( Site 5954)

    Talca, Maule Region, 3465584, Chile

  • Clinica de la Costa S.A.S. ( Site 6055)

    Barranquilla, Atlántico, 080020, Colombia

  • Clinical Research Puerto Rico ( Site 7450)

    San Juan, 00909, Puerto Rico

  • Clinique Medicale lActuel ( Site 5752)

    Montreal, Quebec, H2L 4P9, Canada

  • Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 8350)

    Guatemala City, 01009, Guatemala

  • Columbia University Irving Medical Center-Division of Infectious Diseases ( Site 5688)

    New York, New York, 10032, United States

  • DCOL Center for Clinical Research ( Site 5664)

    Longview, Texas, 75605, United States

  • Desmond Tutu Health Foundation ( Site 6651)

    Cape Town, Western Cape, 7925, South Africa

  • Emory University Hospital Midtown Infectious Disease Clinic ( Site 5673)

    Atlanta, Georgia, 30308, United States

  • Emory University and Grady Health System-Medicine ( Site 5690)

    Atlanta, Georgia, 30308, United States

  • Espacio Eme ( Site 5952)

    Santiago, Region M. de Santiago, 7770086, Chile

  • Ezintsha-Clinical Research Site ( Site 6656)

    Johannesburg, Gauteng, 2193, South Africa

  • Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 7850)

    Bangkok, Bangkok, 10700, Thailand

  • Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6657)

    Cape Town, Western Cape, 7500, South Africa

  • Fundación Huésped ( Site 5850)

    CABA, Buenos Aires, C1427CEA, Argentina

  • Fundación IDEAA ( Site 5851)

    Buenos Aires, C1405CKC, Argentina

  • Fundación Valle del Lili ( Site 6052)

    Cali, Valle del Cauca Department, 760032, Colombia

  • HIV Netherlands Australia Thailand Research Collaboration ( Site 7851)

    Bangkok, Bangkok, 10330, Thailand

  • HOPE Clinical Research ( Site 7451)

    San Juan, 00909, Puerto Rico

  • HOSPITAL CLÍNIC DE BARCELONA-Infection Day Hospital ( Site 6350)

    Barcelona, Catalonia, 08036, Spain

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Unidad de Enfermedades Infecciosas ( Site 6353)

    Madrid, Madrid, Comunidad de, 28007, Spain

  • Hacettepe Universite Hastaneleri ( Site 7650)

    Altindağ, Ankara, 06230, Turkey (Türkiye)

  • Hadassah Medical Center-Infecious Disease ( Site 6752)

    Jerusalem, 9120, Israel

  • Hamilton Health Sciences-Urgent Care Centre ( Site 5750)

    Hamilton, Ontario, L8S 1A4, Canada

  • Helen Joseph Hospital-Clinical HIV Research Unit ( Site 6661)

    Johannesburg, Gauteng, 2092, South Africa

  • Henry Ford Hospital ( Site 5667)

    Detroit, Michigan, 48202, United States

  • Hospital General Universitario de Elche-Infectius Disease ( Site 6358)

    Elche, Alicante, 03202, Spain

  • Hospital Germans Trias i Pujol-Fundació Lluita contra la Sida ( Site 6351)

    Badalona, Barcelona, 08916, Spain

  • Hospital Kuala Lumpur ( Site 7773)

    Kuala Lumpur, 50586, Malaysia

  • Hospital Pulau Pinang ( Site 7779)

    George Town, Pulau Pinang, 10450, Malaysia

  • Hospital Selayang ( Site 7770)

    Batu Caves, Selangor, 68100, Malaysia

  • Hospital Sultanah Bahiyah ( Site 7776)

    Alor Star, Kedah, 05460, Malaysia

  • Hospital Sungai Buloh ( Site 7778)

    Sungai Buloh, Selangor, 47000, Malaysia

  • Hospital Universitari Vall d'Hebron-Infectious Diseases: HIV unit ( Site 6352)

    Barcelona, 08035, Spain

  • Hospital Universitari de Bellvitge ( Site 6360)

    L'Hospitalet de Llobregat,Barcelona, Catalonia, 08907, Spain

  • Hospital Universitario 12 de Octubre ( Site 6355)

    Madrid, 28041, Spain

  • Hospital Universitario Fundación Jiménez Díaz-Internal Medicine. Infectious disease ( Site 6357)

    Madrid, 28015, Spain

  • Hospital Universitario La Paz ( Site 6354)

    Madrid, 28046, Spain

  • Hospital Universitario Ramón y Cajal-ENFERMEDADES INFECCIOSAS ( Site 6361)

    Madrid, Madrid, Comunidad de, 28034, Spain

  • Hospital Universitario San Ignacio-Infectious ( Site 6053)

    Bogotá, Bogota D.C., 110231, Colombia

  • Hospital Universitario Virgen de la Victoria ( Site 6359)

    Málaga, 29010, Spain

  • Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 5955)

    Temuco, Araucania, 4781151, Chile

  • Howard Brown Health Center-Clinical Research ( Site 5665)

    Chicago, Illinois, 60613, United States

  • Human Sciences Research Council-Centre for Community Based Research ( Site 6664)

    Pietermaritzburg, KwaZulu-Natal, 3201, South Africa

  • Hôpital Avicenne ( Site 6160)

    Bobigny, Île-de-France Region, 93000, France

  • Hôpital Bichat - Claude-Bernard ( Site 6162)

    Paris, 75018, France

  • Hôpital Saint Antoine ( Site 6158)

    Paris, 75571, France

  • Hôpital Saint-Louis ( Site 6159)

    Paris, Île-de-France Region, 75010, France

  • Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 8150)

    Geneva, Canton of Geneva, 1205, Switzerland

  • ICH Study Center GmbH & Co. KG ( Site 6259)

    Hamburg, 20146, Germany

  • ID Care ( Site 5676)

    Hillsborough, New Jersey, 08844, United States

  • Instituto CAICI SRL ( Site 5852)

    Rosario, Santa Fe Province, S2000PBJ, Argentina

  • Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 8250)

    Santo Domingo de Guzman, Santo Domingo Province, 10305, Dominican Republic

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 7251)

    Mexico City, Mexico City, 14080, Mexico

  • Instituto Oulton ( Site 5853)

    Córdoba, X5000JJS, Argentina

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 5854)

    Mar del Plata, Buenos Aires, B7600FZO, Argentina

  • Jacobi Medical Center ( Site 5683)

    The Bronx, New York, 10461, United States

  • Josha Research ( Site 6652)

    Bloemfontein, Free State, 9301, South Africa

  • Jubilee Clinical Research ( Site 5679)

    Las Vegas, Nevada, 89106, United States

  • KC CARE Health Center-Clinical Trials ( Site 5670)

    Kansas City, Missouri, 64111, United States

  • KEMRI-CMR-RCTP ( Site 8650)

    Kisumu, 40100, Kenya

  • King's College Hospital ( Site 7950)

    London, London, City of, SE5 9RL, United Kingdom

  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Medizinische Klinik und Poliklinik IV, Sektio

    München, Bavaria, 80336, Germany

  • Las Vegas Research Center ( Site 5691)

    Las Vegas, Nevada, 89106, United States

  • Madibeng Centre for Research ( Site 6660)

    Brits, North West, 0250, South Africa

  • McGill University Health Centre ( Site 5751)

    Montreal, Quebec, H4A 3J1, Canada

  • Mercer University, Department of Internal Medicine ( Site 5655)

    Macon, Georgia, 31201, United States

  • Metro Infectious Diseases Consultants L.L.C. ( Site 5653)

    Decatur, Georgia, 30033, United States

  • Midway Immunology and Research Center ( Site 5657)

    Ft. Pierce, Florida, 34982, United States

  • National Hospital Organization Nagoya Medical Center ( Site 6953)

    Nagoya, Aichi-ken, 460-0001, Japan

  • National Hospital Organization Osaka National Hospital ( Site 6952)

    Osaka, 540-0006, Japan

  • North Texas Infectious Diseases Consultants, P.A ( Site 5651)

    Dallas, Texas, 75246, United States

  • Orlando Immunology Center ( Site 5654)

    Orlando, Florida, 32803, United States

  • PHRD KEMRI (Partners in Health Research & Development) ( Site 8651)

    Nairobi, Nairobi City, 00202, Kenya

  • Pacific Oaks Medical Group ( Site 5681)

    Beverly Hills, California, 90211, United States

  • Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 6654)

    Johannesburg, Gauteng, 2013, South Africa

  • Pitie Salpetriere University Hospital ( Site 6156)

    Paris, Île-de-France Region, 75013, France

  • Ponce Medical School Foundation Inc. ( Site 7452)

    Ponce, 00716, Puerto Rico

  • Prism Health North Texas, Oak Cliff Health Center ( Site 5660)

    Dallas, Texas, 75208, United States

  • Pueblo Family Physicians ( Site 5674)

    Phoenix, Arizona, 85015, United States

  • Qhakaza Mbokodo Research Clinic ( Site 6659)

    Ladysmith, KwaZulu-Natal, 3370, South Africa

  • Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 6751)

    Haifa, 3109601, Israel

  • Regina General Hospital ( Site 5754)

    Regina, Saskatchewan, S4P 0W5, Canada

  • Regional Center for Infectious Diseases ( Site 5687)

    Greensboro, North Carolina, 27401, United States

  • Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 7852

    Chiang Mai, 50200, Thailand

  • Royal London Hospital ( Site 7951)

    London, England, E1 1BB, United Kingdom

  • Ruane Clinical Research Group, Inc ( Site 5658)

    Los Angeles, California, 90036, United States

  • Rush University Medical Center-Infectious Disease ( Site 5671)

    Chicago, Illinois, 60612, United States

  • Saint Michael's Medical Center ( Site 5682)

    Newark, New Jersey, 07102, United States

  • Sarawak General Hospital ( Site 7772)

    Kuching, Sarawak, 93586, Malaysia

  • Sheba Medical Center-HIV unit ( Site 6753)

    Ramat Gan, 5262100, Israel

  • Sourasky Medical Center ( Site 6754)

    Tel Aviv, 6423906, Israel

  • Southmead Hospital ( Site 7952)

    Bristol, Bristol, City of, BS10 5NB, United Kingdom

  • St Hope Foundation ( Site 5659)

    Bellaire, Texas, 77401, United States

  • Texas Centers for Infectious Disease Associates ( Site 5656)

    Fort Worth, Texas, 76104, United States

  • The Hathersage Centre ( Site 7953)

    Manchester, England, M13 0FH, United Kingdom

  • The Mortimer Market Centre for Sexual Health and HIV Research ( Site 7954)

    London, London, City of, WC1E 6JB, United Kingdom

  • Tokyo Medical University Hospital ( Site 6954)

    Shinjuku-ku, Tokyo, 160-0023, Japan

  • Toronto General Hospital ( Site 5753)

    Toronto, Ontario, M5G 2C4, Canada

  • Tourcoing Hospital ( Site 6150)

    Tourcoing, Nord, 59200, France

  • Triple O Research Institute, P.A ( Site 5666)

    West Palm Beach, Florida, 33407, United States

  • Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 5950)

    Santiago, Region M. de Santiago, 8380420, Chile

  • Universitaetsklinikum Freiburg ( Site 6256)

    Freiburg, Brandenburg, 79106, Germany

  • Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 6260)

    Hamburg, 20246, Germany

  • University Hospital Basel-Infectiology ( Site 8151)

    Basel, Canton of Basel-City, 4031, Switzerland

  • University Malaya Medical Centre-Clinical Investigation Centre (CIC) ( Site 7777)

    Lembah Pantai, Kuala Lumpur, 59100, Malaysia

  • University of Cincinnati Medical Center-Infectious Diseases - Outpatient ( Site 5662)

    Cincinnati, Ohio, 45267-0405, United States

  • University of Illinois at Chicago-Project WISH ( Site 5685)

    Chicago, Illinois, 60612, United States

  • Universitätsklinikum Bonn-Immunologie ( Site 6250)

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Vivent Health ( Site 5694)

    Denver, Colorado, 80246, United States

  • Washington Health Institute ( Site 5689)

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

  • Wentworth Hospital ( Site 6653)

    Durban, KwaZulu-Natal, 4052, South Africa

More trials for these conditions

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