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New HIV pill combo could simplify treatment for thousands

NCT ID NCT04223791

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial tested whether people with HIV whose virus is already suppressed can safely switch to a new two-drug pill (doravirine/islatravir) instead of staying on their current three-drug regimen (BIC/FTC/TAF). About 643 participants were randomly assigned to either switch or stay on their current treatment. The main goal was to see if the new pill keeps the virus under control just as well after 48 weeks. The study also tracked side effects and how many people stopped treatment due to problems.

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) combination pill
What this could lead to
If successful, this could offer a new once-daily pill option for people with HIV that is as effective as current treatments.
What could go wrong
This is a switch study in already well-controlled patients, so it only tests non-inferiority, not a cure. Long-term safety and resistance data are still limited.

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

643 people

The number who actually took part.

Started

Feb 2020

Finished

Feb 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 HIV-1 positive with plasma Human Immunodeficiency Virus 1 (HIV-1) RNA \<50 copies/mL at screening. * Has been receiving bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) therapy 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 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 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 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.R.N. dei Colli - Ospedale Cotugno ( Site 3507)

    Naples, 80131, Italy

  • AHF South Beach ( Site 2780)

    Miami Beach, Florida, 33140, United States

  • ASST Fatebenefratelli-Ospedale Sacco ( Site 3500)

    Milan, 20157, Italy

  • Augusta University ( Site 2752)

    Augusta, Georgia, 30912, United States

  • Azienda Ospedaliera San Paolo ( Site 3503)

    Milan, 20142, Italy

  • CAIMED Center - Ponce School of Medicine ( Site 2903)

    Ponce, 00716, Puerto Rico

  • CHU Hotel Dieu Nantes ( Site 3120)

    Nantes, Loire-Atlantique, 44093, France

  • CHU de Montpellier - Hopital Saint-Eloi ( Site 3121)

    Montpellier, Herault, 34295, France

  • CHU de Nancy Hopital Brabois Adultes ( Site 3128)

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France

  • CHU de Nice Hopital Archet 1 ( Site 3103)

    Nice, Alpes-Maritimes, 06202, France

  • Center Hospital of the National Center for Global Health and Medicine ( Site 7201)

    Tokyo, 162-8655, Japan

  • Centre Hospitalier Regional du Orleans ( Site 3108)

    Orléans, Loiret, 45000, France

  • Centre Hospitalier de Tourcoing ( Site 3100)

    Tourcoing, Nord, 59208, France

  • Chatham County Health Department ( Site 2731)

    Savannah, Georgia, 31401, United States

  • Clinical Research Puerto Rico Inc ( Site 2900)

    San Juan, 00909, Puerto Rico

  • Clinique Medicale L Actuel ( Site 2814)

    Montreal, Quebec, H2L 4P9, Canada

  • Clinique de Medecine Urbaine du Quartier Latin ( Site 2804)

    Montreal, Quebec, H2L 4E9, Canada

  • DCOL Center for Clinical Research ( Site 2769)

    Longview, Texas, 75605, United States

  • Dr. Peter Shalit, MD ( Site 2770)

    Seattle, Washington, 98104, United States

  • EPIMED GmbH ( Site 3008)

    Berlin, 12167, Germany

  • Eisenhower Medical Center ( Site 2744)

    Palm Springs, California, 92264, United States

  • Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 3501)

    Milan, Lombardy, 20122, Italy

  • Hamilton Health Sciences ( Site 2803)

    Hamilton, Ontario, L8L 2X2, Canada

  • Helsinki University Hospital ( Site 3200)

    Helsinki, Uusimaa, 00029, Finland

  • Hennepin County Medical Center ( Site 2733)

    Minneapolis, Minnesota, 55415, United States

  • Holdsworth House Medical Practice ( Site 3800)

    Sydney, New South Wales, 2010, Australia

  • Holdsworth House Medical Practice - Brisbane ( Site 3810)

    Brisbane, Queensland, 4006, Australia

  • Hope Clinical Research, Inc. ( Site 2902)

    San Juan, 00909, Puerto Rico

  • Hopital Edouard Herriot ( Site 3126)

    Lyon, Ain, 69003, France

  • Hopital Europeen Marseille ( Site 3117)

    Marseille, Bouches-du-Rhone, 13003, France

  • Hopital Foch ( Site 3129)

    Suresnes, Hauts-de-Seine, 92151, France

  • Hopital Pitie Salpetriere ( Site 3111)

    Paris, 75013, France

  • Hopital Saint-Antoine ( Site 3113)

    Paris, 75012, France

  • Hopital Tenon ( Site 3118)

    Paris, 75020, France

  • Hospital 12 de Octubre de Madrid ( Site 3605)

    Madrid, 28041, Spain

  • Hospital Clinic i Provincial ( Site 3600)

    Barcelona, 08036, Spain

  • Hospital General Universitario Gregorio Maranon ( Site 3603)

    Madrid, 28007, Spain

  • Hospital Universitari Germans Trias i Pujol ( Site 3601)

    Badalona, Barcelona [Barcelona], 08916, Spain

  • Hospital Universitari Vall d Hebron ( Site 3602)

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Hospital Universitari de Bellvitge ( Site 3612)

    LHospitalet de Llobregat, Barcelona [Barcelona], 08907, Spain

  • Hospital Universitario Infanta Leonor ( Site 3606)

    Madrid, 28031, Spain

  • Hospital Universitario La Paz ( Site 3604)

    Madrid, 28046, Spain

  • Hospital Universitario Ramon y Cajal ( Site 3611)

    Madrid, 28034, Spain

  • Hospital Universitario Virgen de la Victoria ( Site 3609)

    Málaga, 29010, Spain

  • ICH Study Center GmbH & Co.KG ( Site 3009)

    Hamburg, 20146, Germany

  • ID Care ( Site 2751)

    Hillsborough, New Jersey, 08844, United States

  • Icahn School of Medicine at Mount Sinai ( Site 2700)

    New York, New York, 10029, United States

  • Infectious Disease Specialists Of Atlanta PC ( Site 2719)

    Decatur, Georgia, 30033, United States

  • Infektiologikum ( Site 3001)

    Frankfurt am Main, Hesse, 60596, Germany

  • Kaiser Permanente Los Angeles Medical Center ( Site 2775)

    Los Angeles, California, 90027, United States

  • Kansas City CARE Clinic ( Site 2718)

    Kansas City, Missouri, 64111, United States

  • Klinikum der LMU München ( Site 3004)

    Munich, Bavaria, 80336, Germany

  • Klinikum rechts der Isar der Technischen Universitat ( Site 3005)

    Munich, Bavaria, 81675, Germany

  • LKH Graz West ( Site 3401)

    Graz, Styria, 8020, Austria

  • MVZ Karlsplatz Dr.med.Hans Jaeger ( Site 3002)

    Munich, Bavaria, 80335, Germany

  • Medical University Vienna ( Site 3402)

    Vienna, State of Vienna, 1090, Austria

  • Medizinische Hochschule Hannover ( Site 3012)

    Hanover, Lower Saxony, 30625, Germany

  • Men's Health Foundation ( Site 2749)

    Los Angeles, California, 80069, United States

  • Mercer University ( Site 2738)

    Macon, Georgia, 31201, United States

  • Midway Immunology and Research ( Site 2759)

    Ft. Pierce, Florida, 34982, United States

  • Montefiore Einstein Center ( Site 2730)

    The Bronx, New York, 10467, United States

  • Multicare Health System ( Site 2713)

    Spokane, Washington, 99204, United States

  • National Hospital Organization Nagoya Medical Center ( Site 7203)

    Nagoya, Aichi-ken, 460-0001, Japan

  • National Hospital Organization Osaka National Hospital ( Site 7202)

    Osaka, 540-0006, Japan

  • North Texas ID Consultants, PA ( Site 2707)

    Dallas, Texas, 75246, United States

  • Orlando Immunology Center ( Site 2734)

    Orlando, Florida, 32803, United States

  • Pacific Oaks Medical Group ( Site 2765)

    Beverly Hills, California, 90211, United States

  • Prahran Market Clinic (PMC) ( Site 3806)

    Melbourne, Victoria, 3181, Australia

  • Pueblo Family Physicians ( Site 2717)

    Phoenix, Arizona, 85015, United States

  • Puerto Rico CONCRA ( Site 2904)

    Rio Piedras, 00925, Puerto Rico

  • Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 3812)

    Herston, Queensland, 4029, Australia

  • Social Medical Center - Otto Wagner Hospital ( Site 3404)

    Vienna, State of Vienna, 1145, Austria

  • Sozialmedizinisches Zentrum Sued - Kaiser-Franz-Josef-Spital ( Site 3400)

    Vienna, State of Vienna, 1100, Austria

  • St Vincent's Hospital ( Site 3807)

    Darlinghurst, New South Wales, 2010, Australia

  • Taylor Square Private Clinic ( Site 3804)

    Darlinghurst, New South Wales, 2010, Australia

  • The Alfred Hospital ( Site 3802)

    Melbourne, Victoria, 3004, Australia

  • The Crofoot Research Center, Inc. ( Site 2715)

    Houston, Texas, 77098, United States

  • The Kinder Medical Group ( Site 2739)

    Miami, Florida, 33133, United States

  • TheraFirst Medical Center ( Site 2742)

    Fort Lauderdale, Florida, 33308, United States

  • Triple O Research Institute, P.A. ( Site 2755)

    West Palm Beach, Florida, 33407, United States

  • Universita' Vita Salute. Ospedale San Raffaele ( Site 3502)

    Milan, 20127, Italy

  • Universitaetsklinikum Bonn ( Site 3000)

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Universitaetsklinikum Essen ( Site 3007)

    Essen, North Rhine-Westphalia, 45122, Germany

  • Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 3010)

    Hamburg, 20246, Germany

  • University of California, Davis, Division of ID Research ( Site 2702)

    Sacramento, California, 95811, United States

  • Vancouver ID Research and Care Centre Society ( Site 2800)

    Vancouver, British Columbia, V6Z 2C7, Canada

  • Whitman-Walker Clinic ( Site 2728)

    Washington D.C., District of Columbia, 20009, United States

  • ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 3003)

    Berlin, 10439, Germany

  • Zuckerberg San Francisco General Hospital UCSF ( Site 2743)

    San Francisco, California, 94110, United States

More trials for these conditions

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