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NCT07266831RecruitingPhase 2/3

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

A Phase 2/3, Randomized, Active-Controlled, Open-Label (Phase 2) and Double-Blind (Phase 3) Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily in Treatment-Naïve Adult Participants Living With HIV-1

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
570 (estimated)
First submitted
1 Dec 2025
Start date
18 Dec 2025
Primary completion date
1 Feb 2029
Lead sponsor
Merck Sharp & Dohme LLC
Diseases
HIV
NCT number
NCT07266831
EU CT number
2025-522519-40-00
EudraCT number
2025-522519-40

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 570
  • From 18 Dec 2025 to the primary completion date, 1 Feb 2029
  • 68 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • 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.

Age

  • 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.

Who the study is looking for

  • 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 and ≤1,000,000 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (68)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fundación IDEAA ( Site 3101)
Coordinator of this site? Confirm its status
Buenos AiresArgentinaRecruiting
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 3102)
Coordinator of this site? Confirm its status
CabaArgentinaRecruiting
Fundación Huesped ( Site 3100)
Coordinator of this site? Confirm its status
CABAArgentinaRecruiting
Instituto de Investigaciones Clinicas Mar del Plata ( Site 3103)
Coordinator of this site? Confirm its status
Mar del PlataArgentinaRecruiting
Instituto CAICI SRL ( Site 3106)
Coordinator of this site? Confirm its status
RosarioArgentinaRecruiting
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 3105)
Coordinator of this site? Confirm its status
San Miguel de TucumánArgentinaRecruiting
Gestion clinique médicale l'Actuel ( Site 3303)
Coordinator of this site? Confirm its status
MontrealCanadaRecruiting
Spectrum Health ( Site 3307)
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VancouverCanadaCompleted
Biomedica Research Group ( Site 4201)
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SantiagoChileRecruiting
Clínica Universidad de Los Andes ( Site 4207)
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SantiagoChileRecruiting
Espacio Eme ( Site 4202)
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SantiagoChileActive, not recruiting
Hospital Germans Trias i Pujol
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BadalonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital General Universitario Santa Lucia
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CartagenaSpainRecruiting
Hospital General Universitario de Elche
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ElcheSpainRecruiting
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Universitario La Paz
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MadridSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainRecruiting
Consorcio Hospital General Universitario de Valencia
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ValenciaSpainRecruiting
Assistance Publique Hopitaux De Paris
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Bobigny CedexFranceRecruiting
Pellegrin Hospital
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BordeauxFranceRecruiting
Assistance Publique Hopitaux De Paris
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CreteilFranceRecruiting
Hospital La Croix Rousse Hcl
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Lyon Cedex 04FranceRecruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceRecruiting
Hospital Hotel Dieu
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NantesFranceRecruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceRecruiting
Centre Hospitalier Universitaire de Nîmes
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NîmesFranceRecruiting
Hopital Saint Louis
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ParisFranceRecruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 18FranceRecruiting
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceRecruiting
Centre Hospitalier De Tourcoing
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Tourcoing CedexFranceRecruiting
CELAN,S.A ( Site 3802)
Coordinator of this site? Confirm its status
Guatemala CityGuatemalaRecruiting
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 3801)
Coordinator of this site? Confirm its status
Guatemala CityGuatemalaRecruiting
MEDI-K ( Site 3803)
Coordinator of this site? Confirm its status
Guatemala CityGuatemalaRecruiting
Morales Vargas Centro de Investigacion, S.C. ( Site 4502)
Coordinator of this site? Confirm its status
LeónMexicoRecruiting
Arké SMO S.A de C.V ( Site 4505)
Coordinator of this site? Confirm its status
VeracruzMexicoRecruiting
Saint Hope Foundation, Inc. ( Site 1504)
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BellaireUnited StatesRecruiting
Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 1533)
Coordinator of this site? Confirm its status
CharlotteUnited StatesRecruiting
Rush University Medical Center-Infectious Disease ( Site 1522)
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
The Ohio State University ( Site 1536)
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ColumbusUnited StatesRecruiting
North Texas Infectious Diseases Consultants ( Site 1500)
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DallasUnited StatesActive, not recruiting
Prism Health North Texas, Oak Cliff Health Center ( Site 1514)
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
Metro Infectious Diseases Consultants L.L.C. ( Site 1509)
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DecaturUnited StatesRecruiting
Vivent Health ( Site 1519)
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DenverUnited StatesRecruiting
Henry Ford Hospital ( Site 1535)
Coordinator of this site? Confirm its status
DetroitUnited StatesRecruiting
Texas Center for Infectious Disease Associates ( Site 1502)
Coordinator of this site? Confirm its status
Fort WorthUnited StatesRecruiting
Midway Immunology and Research Center ( Site 1503)
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Ft. PierceUnited StatesRecruiting
Regional Center for Infectious Diseases ( Site 1516)
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GreensboroUnited StatesRecruiting
ID Care ( Site 1507)
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HillsboroughUnited StatesRecruiting
KC CARE Health Center ( Site 1506)
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Kansas CityUnited StatesRecruiting
DCOL Center for Clinical Research ( Site 1511)
Coordinator of this site? Confirm its status
LongviewUnited StatesRecruiting
Ruane Clinical Research Group, Inc. ( Site 1513)
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Los AngelesUnited StatesRecruiting
Mercer university, Department of internal medicine-Clinical Research ( Site 1512)
Coordinator of this site? Confirm its status
MaconUnited StatesRecruiting
CAN Community Health- Miami Gardens ( Site 1549)
Coordinator of this site? Confirm its status
Miami GardensUnited StatesRecruiting
Orlando Immunology Center ( Site 1501)
Coordinator of this site? Confirm its status
OrlandoUnited StatesRecruiting
University of Pennsylvania Perelman School of Medicine ( Site 1508)
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
CAN Community Health ( Site 1510)
Coordinator of this site? Confirm its status
SarasotaUnited StatesRecruiting
Harborview Medical Center ( Site 1526)
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SeattleUnited StatesRecruiting
Whitman-Walker Institute ( Site 1538)
Coordinator of this site? Confirm its status
Washington D.C.United StatesRecruiting
Triple O Research Institute ( Site 1505)
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West Palm BeachUnited StatesRecruiting
Josha Research ( Site 4302)
Coordinator of this site? Confirm its status
BloemfonteinSouth AfricaRecruiting
Wentworth Hospital ( Site 4303)
Coordinator of this site? Confirm its status
DurbanSouth AfricaRecruiting
Be Part Yoluntu Centre ( Site 4300)
Coordinator of this site? Confirm its status
Mbekweni, PaarlSouth AfricaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.