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Could a weekly pill replace daily HIV treatment? new study aims to find out.

NCT ID NCT07266831

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Updated 8 times

Summary

This study tests whether a once-weekly combination of two experimental drugs (islatravir and ulonivirine) works as well as the standard daily three-drug pill Biktarvy for people newly diagnosed with HIV-1. About 570 adults who have never taken HIV medication will be randomly assigned to one of the two treatments. The main goals are to see if the weekly pill can keep the virus under control and to check its safety and side effects.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 570 people

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

Started

Dec 2025

Expected to finish

Apr 2030

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: * Phase 2: Is human immunodeficiency virus type 1 (HIV-1) positive with Plasma HIV-1 ribonucleic acid (RNA) ≥500 and ≤100,000 copies/mL. * Phase 3: Is HIV-1 positive with Plasma HIV-1 RNA ≥500 copies/mL. * Phase 2: Has cluster of differentiation 4-positive (CD4+) T-cell count ≥200 cells/mm\^3. * Is naïve to antiretroviral therapy (ART), defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection. Exclusion Criteria: * Has human immunodeficiency virus type 2 (HIV-2) infection. * Has a diagnosis of an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection. * Has active hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection. * 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 or in situ anal cancer, or cutaneous Kaposi's sarcoma. * Has prior exposure to islatravir (ISL) or ulonivirine (ULO) for any duration any time prior to Day 1.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease Infections

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Human immunodeficiency virus type 1 (HIV-1) infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    53 sites in 9 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 1533)

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Be Part Yoluntu Centre ( Site 4300)

    RECRUITING

    Mbekweni, Paarl, Western Cape, 7646, South Africa

  • Biomedica Research Group ( Site 4201)

    RECRUITING

    Santiago, Region M. de Santiago, 7500710, Chile

  • Bordeaux University Hospital - Pellegrin ( Site 3605)

    RECRUITING

    Bordeaux, Gironde, 33076, France

  • CAN Community Health ( Site 1510)

    RECRUITING

    Sarasota, Florida, 34237, United States

  • CAN Community Health- Miami Gardens ( Site 1549)

    RECRUITING

    Miami Gardens, Florida, 33055, United States

  • CELAN,S.A ( Site 3802)

    RECRUITING

    Guatemala City, 01010, Guatemala

  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Infectious Disease ( Site 3606)

    RECRUITING

    Nantes, Pays de la Loire Region, 44093, France

  • Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan ( Site 3608)

    RECRUITING

    Toulouse, Haute-Garonne, 31059, France

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 3102)

    RECRUITING

    Caba, Buenos Aires, C1425AGC, Argentina

  • Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 3105)

    RECRUITING

    San Miguel de Tucumán, Tucumán Province, T4000IHE, Argentina

  • Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 3801)

    RECRUITING

    Guatemala City, 01009, Guatemala

  • Clínica Universidad de Los Andes ( Site 4207)

    RECRUITING

    Santiago, Region M. de Santiago, 7620157, Chile

  • Complejo Hospitalario Virgen De La Victoria ( Site 3409)

    RECRUITING

    Málaga, 29010, Spain

  • Consorcio Hospital General Universitario de Valencia ( Site 3406)

    RECRUITING

    Valencia, Valenciana, Comunitat, 46014, Spain

  • DCOL Center for Clinical Research ( Site 1511)

    RECRUITING

    Longview, Texas, 75605, United States

  • Espacio Eme ( Site 4202)

    ACTIVE_NOT_RECRUITING

    Santiago, Region M. de Santiago, 7770086, Chile

  • Fundación Huesped ( Site 3100)

    RECRUITING

    CABA, Buenos Aires, C1427CEA, Argentina

  • Fundación IDEAA ( Site 3101)

    RECRUITING

    Buenos Aires, Buenos Aires F.D., C1405CKC, Argentina

  • Gestion clinique médicale l'Actuel ( Site 3303)

    RECRUITING

    Montreal, Quebec, H2L 4P9, Canada

  • HOPITAL DE LA CROIX ROUSSE ( Site 3613)

    RECRUITING

    Lyon, Rhone, 69317, France

  • HOSPITAL CLÍNIC DE BARCELONA ( Site 3400)

    RECRUITING

    Barcelona, 08036, Spain

  • Harborview Medical Center ( Site 1526)

    RECRUITING

    Seattle, Washington, 98104, United States

  • Henry Ford Hospital ( Site 1535)

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hospital Universitari Vall d'Hebron ( Site 3402)

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre ( Site 3405)

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario La Paz ( Site 3404)

    RECRUITING

    Madrid, Madrid, Comunidad de, 28029, Spain

  • Hôpital Avicenne ( Site 3602)

    RECRUITING

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

  • Hôpital Bichat - Claude-Bernard ( Site 3601)

    RECRUITING

    Paris, Île-de-France Region, 75018, France

  • Hôpital Saint-Louis ( Site 3600)

    RECRUITING

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

  • ID Care ( Site 1507)

    RECRUITING

    Hillsborough, New Jersey, 08844, United States

  • Instituto CAICI SRL ( Site 3106)

    RECRUITING

    Rosario, Santa Fe Province, S2000PBJ, Argentina

  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 3103)

    RECRUITING

    Mar del Plata, Buenos Aires, B7600FZN, Argentina

  • Josha Research ( Site 4302)

    RECRUITING

    Bloemfontein, Free State, 9301, South Africa

  • KC CARE Health Center ( Site 1506)

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • MEDI-K ( Site 3803)

    RECRUITING

    Guatemala City, 01009, Guatemala

  • Mercer university, Department of internal medicine-Clinical Research ( Site 1512)

    RECRUITING

    Macon, Georgia, 31201, United States

  • Metro Infectious Diseases Consultants L.L.C. ( Site 1509)

    RECRUITING

    Decatur, Georgia, 30033, United States

  • Midway Immunology and Research Center ( Site 1503)

    RECRUITING

    Ft. Pierce, Florida, 34982, United States

  • Morales Vargas Centro de Investigacion, S.C. ( Site 4502)

    RECRUITING

    León, Guanajuato, 37000, Mexico

  • North Texas Infectious Diseases Consultants ( Site 1500)

    ACTIVE_NOT_RECRUITING

    Dallas, Texas, 75246, United States

  • Orlando Immunology Center ( Site 1501)

    RECRUITING

    Orlando, Florida, 32803, United States

  • Prism Health North Texas, Oak Cliff Health Center ( Site 1514)

    RECRUITING

    Dallas, Texas, 75208, United States

  • Regional Center for Infectious Diseases ( Site 1516)

    RECRUITING

    Greensboro, North Carolina, 27401, United States

  • Ruane Clinical Research Group, Inc. ( Site 1513)

    RECRUITING

    Los Angeles, California, 90036, United States

  • Rush University Medical Center-Infectious Disease ( Site 1522)

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Saint Hope Foundation, Inc. ( Site 1504)

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Spectrum Health ( Site 3307)

    RECRUITING

    Vancouver, British Columbia, V6Z 2T1, Canada

  • Texas Center for Infectious Disease Associates ( Site 1502)

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • The Ohio State University ( Site 1536)

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Triple O Research Institute ( Site 1505)

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • University of Pennsylvania Perelman School of Medicine ( Site 1508)

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Vivent Health ( Site 1519)

    RECRUITING

    Denver, Colorado, 80246, United States

  • Wentworth Hospital ( Site 4303)

    RECRUITING

    Durban, KwaZulu-Natal, 4052, South Africa

  • Whitman-Walker Institute ( Site 1538)

    RECRUITING

    Washington D.C., District of Columbia, 20032, United States

More trials for these conditions

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