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New Two-Drug combo pill shows promise for easier HIV management

NCT ID NCT04776252

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is checking the long-term safety of a once-daily pill containing two HIV drugs (doravirine and islatravir) in 2,000 adults with HIV-1 who already took it in earlier studies. Participants will take the pill for up to 192 weeks. The goal is to see how many people have serious side effects or need to stop treatment. It's for people who are already doing well on the drug and want to keep taking it.

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 (a two-drug combination pill taken once daily)
What this could lead to
If successful, this could confirm a convenient once-daily two-drug option for long-term HIV control with fewer side effects.
What could go wrong
This is a rollover study for people already on the drug, so it doesn't test effectiveness against a placebo. Long-term safety data is still being collected, and rare side effects may emerge.

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

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

May 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.

Inclusion Criteria: * Is currently receiving DOR 100 mg/ISL 0.75 mg adult FDC tablet in an MSD-sponsored clinical study and has completed the last treatment visit. * Is considered by the investigator to have derived clinical benefit from receiving DOR/ISL and for whom further treatment with DOR/ISL is considered clinically appropriate. * Female is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP); or is a non-pregnant WOCBP who agrees to the following during the intervention period and for at least 6 weeks after the last dose of study intervention: Not be sexually active, or if sexually active, to use an acceptable method of contraception; or is pregnant and continues to receive study intervention (where allowed by local regulations and as appropriate based on available data/local standard-of-care guidelines) Exclusion Criteria: * Is taking or is anticipated to require any prohibited therapies.

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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

  • Biomedica Research Group-Infectology ( Site 0201)

    Santiago, Region M. de Santiago, 7500710, Chile

  • Bliss Healthcare Services-Research ( Site 0030)

    Orlando, Florida, 32806, United States

  • Brighton and Sussex University Hospitals NHS Trust ( Site 2104)

    East Sussex, Brighton And Hove, BN2 5BE, United Kingdom

  • CHU Charles Nicolle-Inefectious disease ( Site 1506)

    Rouen, Haute-Normandie, 76031, France

  • CHU de Bordeaux Hop St ANDRE-Médecine interne et maladies infectieuses ( Site 1512)

    Bordeaux, Gironde, 33075, France

  • CHU de Toulouse-Infectious Disease-Tropical Diseases ( Site 1505)

    Toulouse, Haute-Garonne, 31400, France

  • Cantonal Hospital St.Gallen ( Site 2001)

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

  • Center Hospital of the National Center for Global Health and Medicine ( Site 0901)

    Shinjyuku-ku, Tokyo, 162-8655, Japan

  • Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1516)

    Dijon, Bourgogne-Franche-Comté, 21000, France

  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 1517)

    Nantes, Loire-Atlantique, 44093 Cedex 1, France

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1504)

    Nice, Alpes-Maritimes, 06202, France

  • Centro de Investigacion Clinicadela Universidad Catolica ( Site 0204)

    Santiago, Region M. de Santiago, 8330034, Chile

  • Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 0015)

    Savannah, Georgia, 31401, United States

  • Christchurch Hospital-Infectious Diseases ( Site 0800)

    Christchurch, Canterbury, 8011, New Zealand

  • Clinique Medicale lActuel ( Site 0108)

    Montreal, Quebec, H2L 4P9, Canada

  • Clinique de médecine Urbaine du Quartier Latin ( Site 0110)

    Montreal, Quebec, H2L 4E9, Canada

  • Desmond Tutu Health Foundation ( Site 2402)

    Cape Town, Western Cape, 7925, South Africa

  • EMC Instytut Medyczny S. A. Przychodnia przy ul. Lowieckiej we Wroclawiu ( Site 1700)

    Wroclaw, Lower Silesian Voivodeship, 50-220, Poland

  • Ezintsha ( Site 2404)

    Johannesburg, Gauteng, 2193, South Africa

  • Fiona Stanley Hospital ( Site 0706)

    Murdock, Western Australia, 6150, Australia

  • Fondazione IRCCS Policlinico San Matteo-Dipartimento di Malattie Infettive: SC Malattie Infettive (

    Pavia, Lombardy, 27100, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli-UOC Malattie Infettive ( Site 1606)

    Rome, Lazio, 00168, Italy

  • Fundacion Valle del Lili- CIC ( Site 0300)

    Cali, Valle del Cauca Department, 760032, Colombia

  • Georgetown University Medical Center-Clinical Trials Unit Division of Infectious Diseases ( Site 002

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

  • HOSPITAL CLÍNIC DE BARCELONA-Infection Day Hospital ( Site 1900)

    Barcelona, Catalonia, 08036, Spain

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Unidad de Enfermedades Infecciosas ( Site 1903)

    Madrid, Madrid, Comunidad de, 28007, Spain

  • Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 0109)

    Hamilton, Ontario, L8S 1A4, Canada

  • Holdsworth House Medical Practice ( Site 0700)

    Darlinghurst, New South Wales, 2010, Australia

  • Hospital General Universitario de Elche-Infectius Disease ( Site 1908)

    Elche, Alicante, 03202, Spain

  • Hospital Germans Trias i Pujol-Fundació Lluita contra la Sida ( Site 1901)

    Badalona, Barcelona, 08916, Spain

  • Hospital La Colombière ( Site 1518)

    Montpellier, Herault, 34090, France

  • Hospital Universitario Fundación Jiménez Díaz-Internal Medicine. Infectious disease ( Site 1902)

    Madrid, 28040, Spain

  • Hospital Universitario Infanta Leonor ( Site 1906)

    Madrid, 28031, Spain

  • Hospital Universitario La Paz-Internal Medicine ( Site 1904)

    Madrid, 28046, Spain

  • Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0202)

    Temuco, Araucania, 4781151, Chile

  • Hôpital Avicenne ( Site 1502)

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

  • Hôpital Bichat - Claude-Bernard-infectious diseases ( Site 1523)

    Paris, 75018, France

  • Hôpital Saint-Louis-Infectious Diseases and tropical diseases ( Site 1511)

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

  • Hôpital de la Croix Rousse-Service des Maladies infectieuses et tropicales ( Site 1503)

    Lyon, Rhone, 69004, France

  • Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 2004)

    Geneva, Canton of Geneva, 1211, Switzerland

  • ID Care ( Site 0028)

    Hillsborough, New Jersey, 08844, United States

  • Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 0006)

    New York, New York, 10029, United States

  • Inselspital Bern-Inselspital Infektiologie ( Site 2003)

    Bern, 3010, Switzerland

  • Josha Research ( Site 2403)

    Bloemfontein, Free State, 9300, South Africa

  • KC CARE Health Center-Clinical Trials ( Site 0012)

    Kansas City, Missouri, 64111, United States

  • King Edward VIII Hospital ( Site 2410)

    Durban, KwaZulu-Natal, 4001, South Africa

  • King's College Hospital ( Site 2101)

    London, England, SE5 9RS, United Kingdom

  • Krasnoyarsk Regional Center for the Prevention and Control of AIDS ( Site 2304)

    Krasnoyarsk, Krasnoyarsk Krai, 660049, Russia

  • Kuzbasskiy Center for the Prevention and Control of AIDS ( Site 2305)

    Kemerovo, Kemerovo Oblast, 650056, Russia

  • Maple Leaf Research ( Site 0105)

    Toronto, Ontario, M5G 1K2, Canada

  • Mediclinc Muelmed ( Site 2401)

    Pretoria, Gauteng, 0083, South Africa

  • Medizinische Hochschule Hannover-Department of Immunology and Rheumatology ( Site 1661)

    Hanover, Lower Saxony, 30625, Germany

  • Midway Immunology and Research Center ( Site 0033)

    Ft. Pierce, Florida, 34982, United States

  • Moscow Infectious Diseases Clinical Hospital Number 2 ( Site 2306)

    Moscow, Moscow, 105275, Russia

  • National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 09

    Osaka, 540-0006, Japan

  • National Hospital Organization Nagoya Medical Center ( Site 0903)

    Nagoya, Aichi-ken, 460-0001, Japan

  • North Manchester General Hospital ( Site 2105)

    Manchester, M8 5RB, United Kingdom

  • North Texas Infectious Diseases Consultants, P.A-Research ( Site 0004)

    Dallas, Texas, 75246, United States

  • Northstar Healthcare ( Site 0003)

    Chicago, Illinois, 60657, United States

  • One Community Health ( Site 0045)

    Sacramento, California, 95811, United States

  • Orlando Immunology Center ( Site 0017)

    Orlando, Florida, 32803, United States

  • Ospedale Luigi Sacco-UOC Malattie Infettive I ( Site 1600)

    Milan, Milano, 20157, Italy

  • Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 2005)

    Lugano, Canton Ticino, 6903, Switzerland

  • Ospedale San Raffaele-U.O. Malattie Infettive ( Site 1602)

    Milan, Lombardy, 20127, Italy

  • Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site

    Philadelphia, Pennsylvania, 19104, United States

  • Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 1508)

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

  • Pueblo Family Physicians ( Site 0010)

    Phoenix, Arizona, 85015, United States

  • Republican Clinical Hospital for Infectious Diseases A.F. Agafonova ( Site 2303)

    Kazan', Tatarstan, Respublika, 420140, Russia

  • Republican Clinical Infectious Hospital ( Site 2300)

    Saint Petersburg, Leningradskaya Oblast', 196645, Russia

  • Royal Free Hospital ( Site 2102)

    London, England, NW32QG, United Kingdom

  • Saint-Petersburg Center for Prophylactic of AIDS and Infecti-Saint-Petersburg Center for Prophylact

    Saint Petersburg, Sankt-Peterburg, 190020, Russia

  • Scientific Advisory Clinical Diagnostic Center Central Resea-Federal AIDS Center ( Site 2302)

    Moscow, Moscow, 105275, Russia

  • Sheldon M. Chumir Health Centre-Southern Alberta Clinic ( Site 0106)

    Calgary, Alberta, T2R 0X7, Canada

  • Smolensk Center for prevention and control of AIDS ( Site 2308)

    Smolensk, Smolensk Oblast, 214006, Russia

  • Southmead Hospital ( Site 2103)

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

  • St Hope Foundation ( Site 0041)

    Bellaire, Texas, 77401, United States

  • St Vincent's Hospital-IBAC ( Site 0702)

    Sydney, New South Wales, 2010, Australia

  • Texas Center for Infectious Disease Associates-Clinical Research ( Site 0026)

    Fort Worth, Texas, 76104, United States

  • The Crofoot Research Center ( Site 0008)

    Houston, Texas, 77098, United States

  • Tokyo Medical University Hospital ( Site 0904)

    Shinjuku-ku, Tokyo, 160-0023, Japan

  • Tokyo Metropolitan Komagome Hospital ( Site 0906)

    Tokyo, 113-8677, Japan

  • Toronto General Hospital ( Site 0104)

    Toronto, Ontario, M5G 2C4, Canada

  • Tourcoing Hospital-Service Universitaire des Maladies Infectieuses et du Voyageur ( Site 1519)

    Tourcoing, Nord, 59200, France

  • Triple O Research Institute, P.A ( Site 0031)

    West Palm Beach, Florida, 33407, United States

  • Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0200)

    Santiago, Region M. de Santiago, 8380420, Chile

  • University Hospital Basel-Infectiology ( Site 2002)

    Basel, Canton of Aargau, 4031, Switzerland

  • UniversitätsSpital Zürich ( Site 2000)

    Zurich, Canton of Zurich, 8091, Switzerland

  • Vancouver Infectious Diseases Centre ( Site 0100)

    Vancouver, British Columbia, V6Z 2C7, Canada

  • WSS im. W Bieganskiego O. Chorob Zakaznych i Hepatologii-F ( Site 1701)

    Ód, Łódź Voivodeship, 90-001, Poland

  • Wentworth Hospital ( Site 2400)

    Durban, KwaZulu-Natal, 4052, South Africa

  • Whitman-Walker Institute ( Site 0039)

    Washington D.C., District of Columbia, 20005, United States

  • Wojewódzki Szpital Zakaźny w Warszawie ( Site 1702)

    Warsaw, Masovian Voivodeship, 01-201, Poland

  • Wrocl.Centr.Zdrowia SPZOZ Osr. Prof-Lecz Ch. Zak. i Terapii Uzaleznien ( Site 1703)

    Wroclaw, Lower Silesian Voivodeship, 50-136, Poland

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