A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)

Last updated: April 22, 2026
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

2/3

Condition

Aids And Aids Related Infections

Hiv Infections

Hiv/aids

Treatment

ISL/ULO

BIC/FTC/TAF

Placebo for BIC/FTC/TAF

Clinical Study ID

NCT07266831
8591B-062
MK-8591B-062
2025-522519-40
U1111-1323-4689
  • Ages > 18
  • All Genders

Study Summary

Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in the body. Standard ART helps people live longer, but people must take up to 3 medicines up to twice a day. Standard ART may also cause other health problems. Researchers want to know if a study ART works as well as a standard ART to treat HIV-1. The study ART combines 2 medicines, islatravir and ulonivirine, and is taken once a week. The goals of this study are to learn: 1) If the study ART works as well as a standard ART to treat HIV-1, and 2) About the safety of the study ART and if people tolerate it compared to a standard ART.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Phase 2: Is human immunodeficiency virus type 1 (HIV-1) positive with Plasma HIV-1ribonucleic 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 ≥200cells/mm^3.

  • Is naïve to antiretroviral therapy (ART), defined as having received no priortherapy with any antiretroviral agent following a diagnosis of HIV 1 infection.

Exclusion

Exclusion Criteria:

  • Has human immunodeficiency virus type 2 (HIV-2) infection.

  • Has a diagnosis of an active acquired immune deficiency syndrome (AIDS)-definingopportunistic 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 consentexcept for adequately treated basal cell or squamous cell skin cancer, in situcervical or in situ anal cancer, or cutaneous Kaposi's sarcoma.

  • Has prior exposure to islatravir (ISL) or ulonivirine (ULO) for any duration anytime prior to Day 1.

Study Design

Total Participants: 570
Treatment Group(s): 6
Primary Treatment: ISL/ULO
Phase: 2/3
Study Start date:
December 18, 2025
Estimated Completion Date:
April 03, 2030

Connect with a study center

  • Fundación Huesped ( Site 3100)

    CABA, Buenos Aires C1427CEA
    Argentina

    Active - Recruiting

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

    Caba, Buenos Aires C1425AGC
    Argentina

    Active - Recruiting

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

    Mar del Plata, Buenos Aires B7600FZN
    Argentina

    Active - Recruiting

  • Fundación IDEAA ( Site 3101)

    Buenos Aires, Buenos Aires F.D. C1405CKC
    Argentina

    Active - Recruiting

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

    San Miguel de Tucumán, Tucumán Province T4000IHE
    Argentina

    Active - Recruiting

  • Spectrum Health ( Site 3307)

    Vancouver, British Columbia V6Z 2T1
    Canada

    Active - Recruiting

  • Spectrum Health ( Site 3307)

    Vancouver 6173331, British Columbia 5909050 V6Z 2T1
    Canada

    Site Not Available

  • Gestion clinique médicale l'Actuel ( Site 3303)

    Montreal, Quebec H2L 4P9
    Canada

    Active - Recruiting

  • Gestion clinique médicale l'Actuel ( Site 3303)

    Montreal 6077243, Quebec 6115047 H2L 4P9
    Canada

    Site Not Available

  • Bordeaux University Hospital - Pellegrin ( Site 3605)

    Bordeaux, Gironde 33000
    France

    Active - Recruiting

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

    Toulouse, Haute-Garonne 31059
    France

    Active - Recruiting

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

    Nantes, Pays de la Loire Region 44093
    France

    Active - Recruiting

  • HOPITAL DE LA CROIX ROUSSE ( Site 3613)

    Lyon, Rhone 69317
    France

    Active - Recruiting

  • Hôpital Avicenne ( Site 3602)

    Bobigny, Île-de-France Region 93000
    France

    Active - Recruiting

  • Hôpital Bichat - Claude-Bernard ( Site 3601)

    Paris, Île-de-France Region 75018
    France

    Active - Recruiting

  • Hôpital Saint-Louis ( Site 3600)

    Paris, Île-de-France Region 75010
    France

    Active - Recruiting

  • CELAN,S.A ( Site 3802)

    Guatemala City, 01010
    Guatemala

    Active - Recruiting

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

    Guatemala City, 01009
    Guatemala

    Active - Recruiting

  • MEDI-K ( Site 3803)

    Guatemala City, 01009
    Guatemala

    Active - Recruiting

  • CELAN,S.A ( Site 3802)

    Guatemala City 3598132, 01010
    Guatemala

    Site Not Available

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

    Guatemala City 3598132, 01009
    Guatemala

    Active - Recruiting

  • MEDI-K ( Site 3803)

    Guatemala City 3598132, 01009
    Guatemala

    Active - Recruiting

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

    León, Guanajuato 37000
    Mexico

    Active - Recruiting

  • Arké SMO S.A de C.V ( Site 4505)

    Veracruz, 91910
    Mexico

    Active - Recruiting

  • Wentworth Hospital ( Site 4303)

    Durban, KwaZulu-Natal 4052
    South Africa

    Active - Recruiting

  • Be Part Yoluntu Centre ( Site 4300)

    Mbekweni, Paarl, Western Cape 7646
    South Africa

    Active - Recruiting

  • Hospital Universitario La Paz ( Site 3404)

    Madrid, Madrid, Comunidad de 28029
    Spain

    Active - Recruiting

  • Consorcio Hospital General Universitario de Valencia ( Site 3406)

    Valencia, Valenciana, Comunitat 46014
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron ( Site 3402)

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Complejo Hospitalario Virgen De La Victoria ( Site 3409)

    Málaga, 29010
    Spain

    Active - Recruiting

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

    Los Angeles, California 90036
    United States

    Active - Recruiting

  • Vivent Health ( Site 1519)

    Denver, Colorado 80246
    United States

    Active - Recruiting

  • Vivent Health ( Site 1519)

    Denver 5419384, Colorado 5417618 80246
    United States

    Site Not Available

  • Whitman-Walker Institute ( Site 1538)

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

    Active - Recruiting

  • Whitman-Walker Institute ( Site 1538)

    Washington D.C. 4140963, District of Columbia 4138106 20032
    United States

    Site Not Available

  • Midway Immunology and Research Center ( Site 1503)

    Ft. Pierce, Florida 34982
    United States

    Active - Recruiting

  • CAN Community Health- Miami Gardens ( Site 1549)

    Miami, Florida 33055
    United States

    Site Not Available

  • CAN Community Health- Miami Gardens ( Site 1549)

    Miami Gardens, Florida 33055
    United States

    Active - Recruiting

  • Orlando Immunology Center ( Site 1501)

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • CAN Community Health ( Site 1510)

    Sarasota, Florida 34237
    United States

    Active - Recruiting

  • Triple O Research Institute ( Site 1505)

    West Palm Beach, Florida 33407
    United States

    Active - Recruiting

  • Midway Immunology and Research Center ( Site 1503)

    Ft. Pierce 4156018, Florida 4155751 34982
    United States

    Site Not Available

  • Midway Immunology and Research Center (1503)

    Ft. Pierce 4156018, Florida 4155751 34982
    United States

    Active - Recruiting

  • CAN Community Health- Miami Gardens ( Site 1549)

    Miami 4164138, Florida 4155751 33055
    United States

    Site Not Available

  • Orlando Immunology Center ( Site 1501)

    Orlando 4167147, Florida 4155751 32803
    United States

    Site Not Available

  • CAN Community Health ( Site 1510)

    Sarasota 4172131, Florida 4155751 34237
    United States

    Site Not Available

  • Triple O Research Institute ( Site 1505)

    West Palm Beach 4177887, Florida 4155751 33407
    United States

    Site Not Available

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

    Decatur, Georgia 30033
    United States

    Active - Recruiting

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

    Macon, Georgia 31201
    United States

    Active - Recruiting

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

    Decatur 4191124, Georgia 4197000 30033
    United States

    Site Not Available

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

    Macon 4207400, Georgia 4197000 31201
    United States

    Site Not Available

  • Henry Ford Hospital ( Site 1535)

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • KC CARE Health Center ( Site 1506)

    Kansas City, Missouri 64111
    United States

    Active - Recruiting

  • KC CARE Health Center ( Site 1506)

    Kansas City 4393217, Missouri 4398678 64111
    United States

    Site Not Available

  • ID Care ( Site 1507)

    Hillsborough, New Jersey 08844
    United States

    Active - Recruiting

  • ID Care ( Site 1507)

    Hillsborough 5099079, New Jersey 5101760 08844
    United States

    Site Not Available

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

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Regional Center for Infectious Diseases ( Site 1516)

    Greensboro, North Carolina 27401
    United States

    Active - Recruiting

  • Regional Center for Infectious Diseases ( Site 1516)

    Greensboro 4469146, North Carolina 4482348 27401
    United States

    Site Not Available

  • The Ohio State University ( Site 1536)

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • The Ohio State University ( Site 1536)

    Columbus 4509177, Ohio 5165418 43210
    United States

    Site Not Available

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

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Saint Hope Foundation, Inc. ( Site 1504)

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • North Texas Infectious Diseases Consultants ( Site 1500)

    Dallas, Texas 75246
    United States

    Active - Recruiting

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

    Dallas, Texas 75208
    United States

    Active - Recruiting

  • Texas Center for Infectious Disease Associates ( Site 1502)

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • DCOL Center for Clinical Research ( Site 1511)

    Longview, Texas 75605
    United States

    Active - Recruiting

  • Saint Hope Foundation, Inc. ( Site 1504)

    Bellaire 4673353, Texas 4736286 77401
    United States

    Site Not Available

  • North Texas Infectious Diseases Consultants ( Site 1500)

    Dallas 4684888, Texas 4736286 75246
    United States

    Site Not Available

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

    Dallas 4684888, Texas 4736286 75208
    United States

    Active - Recruiting

  • Texas Center for Infectious Disease Associates ( Site 1502)

    Fort Worth 4691930, Texas 4736286 76104
    United States

    Site Not Available

  • DCOL Center for Clinical Research ( Site 1511)

    Longview 4707814, Texas 4736286 75605
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.