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New HIV pill combo aims to keep virus suppressed with just one daily tablet

NCT ID NCT05631093

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether switching to a once-daily pill containing doravirine and islatravir (DOR/ISL) works as well as staying on current HIV medications for people whose virus is already undetectable. About 550 adults with HIV-1 who have been on stable therapy for at least 3 months will be randomly assigned to either switch to DOR/ISL or continue their current regimen. The main goals are to see if the switch keeps the virus suppressed and is safe over 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

553 people

The number who actually took part.

Started

Feb 2023

Expected to finish

Jul 2028

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 Human Immunodeficiency Virus-1 (HIV-1) positive with plasma HIV-1 Ribonucleic Acid (RNA) \<50 copies/mL at screening * Has been receiving continuous, stable oral 2-drug or 3-drug combination (± PK booster) antiretroviral therapy ART with documented viral suppression (HIV-1 RNA \<50 copies/mL) for ≥3 consecutive months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen * Female is not a participant of childbearing potential (POCBP); or if a POCBP uses an acceptable contraceptive method or abstains from penile-vaginal intercourse as their preferred and usual lifestyle; has a negative highly sensitive pregnancy test; and whose medical history, menstrual history, and recent sexual activity has been reviewed by the investigator 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 acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 30 days prior to screening * Has active hepatitis B virus (HBV) infection * Has chronic hepatitis C virus (HCV) infection consistent with cirrhosis * Has a ≤5 years prior history of malignancy * Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome P450 3A (CYP3A) inducers * Has taken long-acting HIV therapy at any time * Is currently participating in or has participated in a clinical study and received (or is receiving) 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 Doravine (DOR)

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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

  • Be Part Yoluntu Centre ( Site 3901)

    Paarl, Western Cape, 7646, South Africa

  • Brighton and Sussex University Hospitals NHS Trust ( Site 4104)

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

  • CAN Community Health - Sarasota ( Site 3017)

    Sarasota, Florida, 34237, United States

  • CHUV (centre hospitalier universitaire vaudois) ( Site 4006)

    Lausanne, Canton of Vaud, 1011, Switzerland

  • Center Hospital of the National Center for Global Health and Medicine ( Site 4401)

    Shinjyuku-ku, Tokyo, 162-8655, Japan

  • Central Texas Clinical Research ( Site 3015)

    Austin, Texas, 78705, United States

  • Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3028)

    Savannah, Georgia, 31401, United States

  • Ciensalud Ips S A S ( Site 3300)

    Barranquilla, Atlántico, 08001, Colombia

  • Clinica de la Costa S.A.S. ( Site 3305)

    Barranquilla, Atlántico, 080020, Colombia

  • Clinique Medicale lActuel-Clinical Research ( Site 3100)

    Montreal, Quebec, H2L 4P9, Canada

  • Clinique de médecine Urbaine du Quartier Latin ( Site 3101)

    Montreal, Quebec, H2L 4E9, Canada

  • DCOL Center for Clinical Research ( Site 3022)

    Longview, Texas, 75605, United States

  • Desmond Tutu Health Foundation ( Site 3902)

    Cape Town, Western Cape, 7925, South Africa

  • Ezintsha-Clinical Research Site ( Site 3907)

    Johannesburg, Gauteng, 2193, South Africa

  • Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 3908)

    Cape Town, Western Cape, 7505, South Africa

  • Fundacion Valle del Lili- CIC ( Site 3302)

    Cali, Valle del Cauca Department, 760032, Colombia

  • Georgetown University Medical Center ( Site 3006)

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

  • Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 3104)

    Hamilton, Ontario, L8S 1A4, Canada

  • Heartlands Hospital ( Site 4102)

    Birmingham, B9 5SS, United Kingdom

  • Helen Joseph Hospital ( Site 3910)

    Johannesburg, Gauteng, 2092, South Africa

  • Holdsworth House Medical Practice ( Site 4200)

    Darlinghurst, New South Wales, 2010, Australia

  • Holdsworth House Medical Practice - Brisbane ( Site 4201)

    Brisbane, Queensland, 4006, Australia

  • Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 4004)

    Geneva, Canton of Geneva, 1211, Switzerland

  • ID Care ( Site 3041)

    Hillsborough, New Jersey, 08844, United States

  • Infectious Disease Specialists of Atlanta ( Site 3003)

    Decatur, Georgia, 30033, United States

  • Inselspital Bern-Inselspital Infektiologie ( Site 4003)

    Bern, 3010, Switzerland

  • Josha Research ( Site 3903)

    Bloemfontein, Free State, 9300, South Africa

  • Kaiser Permanente-Infectious Disease ( Site 3014)

    Los Angeles, California, 90027, United States

  • King's College Hospital ( Site 4108)

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

  • Maple Leaf Research ( Site 3103)

    Toronto, Ontario, M5G 1K2, Canada

  • Midway Immunology and Research Center ( Site 3009)

    Ft. Pierce, Florida, 34982, United States

  • National Hospital Organization Nagoya Medical Center ( Site 4403)

    Nagoya, Aichi-ken, 460-0001, Japan

  • North Manchester General Hospital ( Site 4107)

    Crumpsall, England, M8 5RB, United Kingdom

  • Orlando Immunology Center ( Site 3004)

    Orlando, Florida, 32803, United States

  • Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 4005)

    Lugano, Canton Ticino, 6903, Switzerland

  • Palmtree Clinical Research ( Site 3032)

    Palm Springs, California, 92262, United States

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

    Philadelphia, Pennsylvania, 19104, United States

  • Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 3905)

    Johannesburg, Gauteng, 2013, South Africa

  • Prahran Market Clinic ( Site 4202)

    Melbourne, Victoria, 3181, Australia

  • Private Practice Dr. Marleen de Jager ( Site 3900)

    Pretoria, Gauteng, 0007, South Africa

  • Royal Brisbane and Women's Hospital-Infectious Diseases Research ( Site 4204)

    Brisbane, Queensland, 4029, Australia

  • Royal Free Hospital ( Site 4101)

    London, England, NW32QG, United Kingdom

  • Royal London Hospital ( Site 4100)

    London, England, E1 1BB, United Kingdom

  • Royal Victoria Infirmary ( Site 4105)

    Newcastle upon Tyne, England, NE1 4LP, United Kingdom

  • St Vincent's Hospital-IBAC ( Site 4203)

    Sydney, New South Wales, 2010, Australia

  • The Crofoot Research Center ( Site 3040)

    Houston, Texas, 77098, United States

  • Tokyo Medical University Hospital ( Site 4404)

    Shinjuku-ku, Tokyo, 160-0023, Japan

  • Toronto General Hospital ( Site 3102)

    Toronto, Ontario, M5G 2M1, Canada

  • Triple O Research Institute, P.A ( Site 3026)

    West Palm Beach, Florida, 33407, United States

  • University Hospital Basel-Infectiology ( Site 4002)

    Basel, Canton of Basel-City, 4031, Switzerland

  • UniversitätsSpital Zürich ( Site 4000)

    Zurich, Canton of Zurich, 8091, Switzerland

  • Wentworth Hospital ( Site 3904)

    Durban, KwaZulu-Natal, 4052, South Africa

  • Zuckerberg San Francisco General Hospital and Trauma Center-UCSF ID Clinical Trials Center ( Site 30

    San Francisco, California, 94110, United States

More trials for these conditions

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