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New HIV pill matches standard therapy in major trial

NCT ID NCT04223778

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 3 study tested whether switching to a once-daily combination pill (doravirine/islatravir) works as well as staying on standard HIV therapy. 672 adults with HIV whose virus was already suppressed took part. Results showed the new pill kept the virus under control just as effectively, with similar side effects.

What this could mean

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

Active substance
doravirine/islatravir (DOR/ISL)
What this could lead to
If successful, this could offer people with HIV a simpler, once-daily pill option that keeps the virus suppressed.
What could go wrong
This is a completed Phase 3 trial, but it only tested a switch in people already well-controlled. It may not work for everyone, and long-term safety beyond 48 weeks is not yet known.

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

672 people

The number who actually took part.

Started

Feb 2020

Finished

Aug 2024

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 (HIV-1) positive * Has been receiving continuous, stable oral 2-drug or 3-drug combination (± pharmacokinetic (PK) booster) with documented viral suppression (HIV-1 RNA \<50 copies/mL) for ≥3 months prior to signing informed consent and has no history of prior virologic treatment failure on any past or current regimen. * Females are eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP); is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle; 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; if a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive 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 an active diagnosis of hepatitis due to any cause, including active Hepatitis B Virus (HBV) co-infection * 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 * Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies * Is currently taking long-acting cabotegravir-rilpivirine * 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 treatment period * Has a documented or known virologic resistance to doravirine (DOR) * Expects 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 infection

Contacts and locations

Locations

  • A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 2208)

    Naples, 80131, Italy

  • A.P.H. Paris, Hopital Saint Louis ( Site 2014)

    Paris, 75010, France

  • ASST Fatebenefratelli-Ospedale Sacco ( Site 2200)

    Milan, 20157, Italy

  • Bliss Healthcare Services ( Site 1025)

    Orlando, Florida, 32806, United States

  • Brighton and Sussex University Hospital NHS Trust ( Site 1908)

    Brighton, Brighton And Hove, BN2 1ES, United Kingdom

  • CHU Hotel Dieu Nantes ( Site 2020)

    Nantes, Loire-Atlantique, 44093, France

  • CHU de Bordeaux- Hopital Saint Andre ( Site 2015)

    Bordeaux, Gironde, 33075, France

  • CHU de Rouen ( Site 2005)

    Rouen, Seine-Maritime, 76031, France

  • CHU de Toulouse - Hopital Purpan ( Site 2004)

    Toulouse, Haute-Garonne, 31059, France

  • Center Hospital of the National Center for Global Health and Medicine ( Site 2401)

    Tokyo, 162-8655, Japan

  • Centro de Investigacion Clinica UC CICUC ( Site 1303)

    Santiago, Santiago Metropolitan, 8330034, Chile

  • Chatham County Health Department ( Site 1043)

    Savannah, Georgia, 31401, United States

  • Christchurch Hospital ( Site 2303)

    Christchurch, Canterbury, 8011, New Zealand

  • Clinica Arauco Salud ( Site 1300)

    Santiago, Santiago Metropolitan, 7560994, Chile

  • Clinique Medicale L Actuel ( Site 1114)

    Montreal, Quebec, H2L 4P9, Canada

  • Clinique de Medecine Urbaine du Quartier Latin ( Site 1104)

    Montreal, Quebec, H2L 4E9, Canada

  • Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1414)

    Cape Town, Western Cape, 7925, South Africa

  • EMC Instytut Medyczny SA Przychodnia przy ul. Lowieckiej we Wroclawiu ( Site 1500)

    Wroclaw, Lower Silesian Voivodeship, 50-220, Poland

  • FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 1700)

    Saint Petersburg, Sankt-Peterburg, 196645, Russia

  • Federal Scientific Methodological AIDS Prevention and Control Center ( Site 1703)

    Moscow, Moscow, 105275, Russia

  • Fiona Stanley Hospital ( Site 2301)

    Murdoch, Western Australia, 6150, Australia

  • Fundacion Valle del Lili ( Site 1201)

    Cali, Valle del Cauca Department, 760032, Colombia

  • Georgetown University Hospital ( Site 1018)

    Washington D.C., District of Columbia, 20007, United States

  • Hamilton Health Sciences ( Site 1103)

    Hamilton, Ontario, L8L 2X2, Canada

  • Holdsworth House Medical Practice ( Site 2300)

    Sydney, New South Wales, 2010, Australia

  • Hopital Francois Mitterrand ( Site 2019)

    Dijon, Cote-d'Or, 21079, France

  • Hopital de la Croix-Rousse ( Site 2027)

    Lyon, Auvergne-Rhône-Alpes, 69317, France

  • Hopitaux Universitaires de Geneve HUG. ( Site 3304)

    Geneva, Canton of Geneva, 1211, Switzerland

  • Hospital Clinic i Provincial ( Site 1600)

    Barcelona, 08036, Spain

  • Hospital Dr. Hernan Henriquez Aravena ( Site 1305)

    Temuco, Araucania, 4781151, Chile

  • Hospital General Universitario Gregorio Maranon ( Site 1603)

    Madrid, 28007, Spain

  • Hospital General de Elche ( Site 1608)

    Elche, Alicante, 03202, Spain

  • Hospital Universitari Germans Trias i Pujol ( Site 1606)

    Badalona, Barcelona [Barcelona], 08916, Spain

  • Hospital Universitario Fundacion Jimenez Diaz ( Site 1602)

    Madrid, 28040, Spain

  • Hospital Universitario Infanta Leonor ( Site 1601)

    Madrid, 28031, Spain

  • Hospital Universitario La Paz ( Site 1604)

    Madrid, 28046, Spain

  • ID Care ( Site 1023)

    Hillsborough, New Jersey, 08844, United States

  • Infectious Clinical Hospital #2 ( Site 1719)

    Moscow, Moscow, 105275, Russia

  • Inselspital Universitaetsspital Bern ( Site 3303)

    Bern, Canton of Bern, 3010, Switzerland

  • JOSHA Research ( Site 1406)

    Bloemfontein, Free State, 9301, South Africa

  • Kansas City CARE Health Center ( Site 1008)

    Kansas City, Missouri, 64111, United States

  • Kantonsspital St. Gallen ( Site 3301)

    Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

  • Kemerovo Regional Center for the Prevention and Control of AIDS ( Site 1713)

    Kemerovo, Kemerovo Oblast, 650056, Russia

  • Kings College Hospital NHS Foundation Trust ( Site 1907)

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

  • Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 1712)

    Krasnoyarsk, Krasnoyarsk Krai, 660049, Russia

  • Maple Leaf Research ( Site 1112)

    Toronto, Ontario, M5G 1K2, Canada

  • Melbourne Sexual Health Centre ( Site 2305)

    Carlton, Victoria, 3053, Australia

  • Midway Immunology and Research ( Site 1030)

    Ft. Pierce, Florida, 34982, United States

  • National Hospital Organization Nagoya Medical Center ( Site 2403)

    Nagoya, Aichi-ken, 460-0001, Japan

  • National Hospital Organization Osaka National Hospital ( Site 2402)

    Osaka, 540-0006, Japan

  • North Manchester General Hospital ( Site 1902)

    Manchester, M8 5RB, United Kingdom

  • North Texas ID Consultants, PA ( Site 1003)

    Dallas, Texas, 75246, United States

  • Northstar Healthcare ( Site 1002)

    Chicago, Illinois, 60657, United States

  • Orlando Immunology Center ( Site 1007)

    Orlando, Florida, 32803, United States

  • Ospedale Regionale di Lugano Civico ( Site 3305)

    Lugano, Canton Ticino, 6903, Switzerland

  • Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 2206)

    Roma, 00168, Italy

  • Regional Center for Prevent. and Control of AIDS and Inf. Diseases ( Site 1715)

    Yekaterinburg, Sverdlovsk Oblast, 620102, Russia

  • Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 1707)

    Kazan', Tatarstan, Respublika, 420140, Russia

  • Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 2309)

    Herston, Queensland, 4029, Australia

  • Royal Free Hospital ( Site 1904)

    London, Camden, NW3 2QG, United Kingdom

  • SP ZOZ Wojewodzki Szpital Zakazny ( Site 1505)

    Warsaw, Masovian Voivodeship, 01-201, Poland

  • Saint Hope Foundation, Inc. ( Site 1037)

    Bellaire, Texas, 77401, United States

  • Saint Petersburg Center for Prophylactic of AIDS and Inf. Diseases ( Site 1701)

    Saint Petersburg, Leningradskaya Oblast', 190020, Russia

  • Southern Alberta HIV Clinic ( Site 1108)

    Calgary, Alberta, T2R 0X7, Canada

  • Southmead Hospital ( Site 1910)

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

  • Texas Centers for Infectious Disease Associates P.A. ( Site 1022)

    Fort Worth, Texas, 76104, United States

  • The Crofoot Research Center, Inc. ( Site 1005)

    Houston, Texas, 77098, United States

  • Tokyo Medical University Hospital ( Site 2404)

    Tokyo, 160-0023, Japan

  • Tokyo Metropolitan Komagome Hospital ( Site 2406)

    Tokyo, 113-8677, Japan

  • Toronto General Hospital - University Health Network ( Site 1105)

    Toronto, Ontario, M5G 2N2, Canada

  • Triple O Research Institute, P.A. ( Site 1026)

    West Palm Beach, Florida, 33407, United States

  • Universitaetsspital Basel ( Site 3302)

    Basel, Canton of Basel-City, 4031, Switzerland

  • Universitaetsspital Zuerich ( Site 3300)

    Zurich, Canton of Zurich, 8091, Switzerland

  • University of North Carolina at Chapel Hill ( Site 1042)

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania ( Site 1038)

    Philadelphia, Pennsylvania, 19104, United States

  • Vancouver ID Research and Care Centre Society ( Site 1100)

    Vancouver, British Columbia, V6Z 2C7, Canada

  • Wojewodzki Szpital Specjalistyczny im. dr. Wladyslawa Bieganskiego ( Site 1503)

    Lodz-Baluty, Łódź Voivodeship, 91-347, Poland

  • Wroclawskie Centrum Zdrowia SP ZOZ ( Site 1507)

    Wroclaw, 50-136, Poland

More trials for these conditions

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