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Could a new Once-Daily pill keep HIV in check? major trial underway

NCT ID NCT05630755

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 if people with HIV whose virus is already well-controlled on a standard three-drug pill (BIC/FTC/TAF) can safely switch to a new two-drug pill (DOR/ISL) taken once daily. About 514 adults with suppressed HIV will be randomly assigned to either stay on their current meds or switch to DOR/ISL. The main goal is to see if the new pill keeps the virus undetectable just as well and has similar side effects 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

514 people

The number who actually took part.

Started

Feb 2023

Expected to finish

Aug 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.

The key inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Is HIV-1 positive with plasma HIV-1 RNA \<50 copies/mL * Has been receiving BIC/FTC/TAF therapy 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 participant of childbearing potential, 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 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 with laboratory values 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 * Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome P450 3A (CYP3A) inducers * Has a documented or known virologic resistance to DOR * Has taken long-acting HIV therapy at any time (e.g., cabotegravir, lenacapavir) * 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 except those currently enrolled in the comparator arm of an ongoing DOR/ISL 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-1-infection

Contacts and locations

Locations

  • AHF The Kinder Medical Group ( Site 1426)

    Miami, Florida, 33133, United States

  • AccessHealth MA ( Site 1419)

    Boston, Massachusetts, 02129, United States

  • Be Well Medical Center ( Site 1408)

    Berkley, Michigan, 48072, United States

  • Center Hospital of the National Center for Global Health and Medicine ( Site 6601)

    Shinjyuku-ku, Tokyo, 162-8655, Japan

  • Central Texas Clinical Research ( Site 1413)

    Austin, Texas, 78705, United States

  • Clinica Universidad Catolica del Maule ( Site 2204)

    Talca, Maule Region, 3465584, Chile

  • Clínica Universidad de Los Andes ( Site 2206)

    Santiago, Region M. de Santiago, 7620001, Chile

  • DCOL Center for Clinical Research ( Site 1415)

    Longview, Texas, 75605, United States

  • Guy's & St Thomas' NHS Foundation Trust ( Site 5808)

    London, London, City of, SE1 9RT, United Kingdom

  • Hadassah Medical Center-Infecious Disease ( Site 4802)

    Jerusalem, 9120, Israel

  • Holdsworth House Medical Practice ( Site 6200)

    Darlinghurst, New South Wales, 2010, Australia

  • Holdsworth House Medical Practice - Brisbane ( Site 6201)

    Brisbane, Queensland, 4006, Australia

  • Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 2205)

    Temuco, Araucania, 4781151, Chile

  • Infectious Disease Specialists of Atlanta ( Site 1403)

    Decatur, Georgia, 30033, United States

  • KC CARE Health Center-Clinical Trials ( Site 1422)

    Kansas City, Missouri, 64111, United States

  • Las Vegas Research Center ( Site 1436)

    Las Vegas, Nevada, 89106, United States

  • Mercer University, Department of Internal Medicine ( Site 1411)

    Macon, Georgia, 31201, United States

  • Midway Immunology and Research Center ( Site 1401)

    Ft. Pierce, Florida, 34982, United States

  • Mills Clinical Research ( Site 1433)

    Los Angeles, California, 90069, United States

  • National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 66

    Osaka, 540-0006, Japan

  • National Hospital Organization Nagoya Medical Center ( Site 6603)

    Nagoya, Aichi-ken, 460-0001, Japan

  • North Texas Infectious Diseases Consultants, P.A ( Site 1404)

    Dallas, Texas, 75246, United States

  • Orlando Immunology Center ( Site 1407)

    Orlando, Florida, 32803, United States

  • Pacific Oaks Medical Group ( Site 1400)

    Beverly Hills, California, 90211, United States

  • Prahran Market Clinic ( Site 6202)

    Melbourne, Victoria, 3181, Australia

  • Prism Health North Texas, Oak Cliff Health Center ( Site 1409)

    Dallas, Texas, 75205, United States

  • Pueblo Family Physicians ( Site 1425)

    Phoenix, Arizona, 85015, United States

  • Queen Elizabeth Hospital Birmingham ( Site 5809)

    Birmingham, England, B15 2TH, United Kingdom

  • Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 4801)

    Haifa, 3109601, Israel

  • Regional Center for Infectious Disease Research ( Site 1435)

    Greensboro, North Carolina, 27401, United States

  • Royal Berkshire Hospital ( Site 5813)

    Reading, RG1 5AN, United Kingdom

  • Royal Brisbane and Women's Hospital-Infectious Diseases Research ( Site 6204)

    Brisbane, Queensland, 4029, Australia

  • Royal Free Hospital ( Site 5801)

    London, England, NW32QG, United Kingdom

  • Royal Liverpool University Hospital ( Site 5812)

    Liverpool, England, L7 8XP, United Kingdom

  • Royal London Hospital ( Site 5800)

    London, England, E1 1BB, United Kingdom

  • Ruane Clinical Research Group, Inc ( Site 1414)

    Los Angeles, California, 90036, United States

  • Sheba Medical Center-HIV unit ( Site 4803)

    Ramat Gan, 5262100, Israel

  • Sourasky Medical Center ( Site 4804)

    Tel Aviv, 64239, Israel

  • Southmead Hospital ( Site 5805)

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

  • St Hope Foundation ( Site 1410)

    Bellaire, Texas, 77401, United States

  • St Vincent's Hospital-IBAC ( Site 6203)

    Sydney, New South Wales, 2010, Australia

  • Texas Centers for Infectious Disease Associates ( Site 1406)

    Fort Worth, Texas, 76104, United States

  • The Crofoot Research Center ( Site 1424)

    Houston, Texas, 77098, United States

  • The Mortimer Market Centre for Sexual Health and HIV Research ( Site 5810)

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

  • Therafirst Medical Center ( Site 1402)

    Fort Lauderdale, Florida, 33308, United States

  • Triple O Research Institute, P.A ( Site 1417)

    West Palm Beach, Florida, 33407, United States

  • Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 2200)

    Santiago, Region M. de Santiago, 8380420, Chile

  • University Hospital of Wales ( Site 5803)

    Cardiff, Wales, CF14 4XW, United Kingdom

  • Whitman-Walker Institute ( Site 1431)

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

More trials for these conditions

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