RecruitingPhase 2Phase 3NCT07266831

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

Sponsor

Merck Sharp & Dohme LLC

Enrollment

570 participants

Start Date

Dec 18, 2025

Study Type

INTERVENTIONAL

Conditions

Human Immunodeficiency Virus Type 1 (HIV-1) Infection

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new two-drug combination — islatravir (ISL) and ulonivirine (ULO) — as a treatment for people with HIV-1 who have never taken antiretroviral (HIV) medication before. The goal is to find the right dose and then test effectiveness and safety compared to existing HIV treatments. **You may be eligible if...** - You have HIV-1 (confirmed positive) - You have never taken any antiretroviral medication before - In Phase 2: your HIV viral load is between 500 and 100,000 copies/mL and your CD4 count is 200 or higher - In Phase 3: your HIV viral load is 500 copies/mL or higher **You may NOT be eligible if...** - You have HIV-2 (a different strain) - You have an active AIDS-defining illness (a serious infection or cancer caused by advanced HIV) - You have active hepatitis B or C - You have had a cancer diagnosis in the past 5 years (certain minor skin cancers may be exceptions) - You have previously taken islatravir or ulonivirine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGISL

ISL 2 x 1 mg oral capsules administered qw for 96 weeks

DRUGULO

ULO 2 x 100 mg oral tablets administered qw for 96 weeks

DRUGBIC/FTC/TAF

BIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks

DRUGPlacebo for BIC/FTC/TAF

BIC/FTC/TAF-matching placebo oral tablet administered qd for 96 weeks

DRUGPlacebo to ISL/ULO

ISL/ULO-matching placebo oral tablets administered qw for 96 weeks

DRUGISL/ULO

ISL/ULO fixed-dose combination 2 mg/200 mg oral tablet administered qw for 96 weeks

Locations(47)

Ruane Clinical Research Group, Inc. ( Site 1513)

Los Angeles, California, United States

Vivent Health ( Site 1519)

Denver, Colorado, United States

Whitman-Walker Institute ( Site 1538)

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

Midway Immunology and Research Center ( Site 1503)

Ft. Pierce, Florida, United States

CAN Community Health- Miami Gardens ( Site 1549)

Miami Gardens, Florida, United States

Orlando Immunology Center ( Site 1501)

Orlando, Florida, United States

CAN Community Health ( Site 1510)

Sarasota, Florida, United States

Triple O Research Institute ( Site 1505)

West Palm Beach, Florida, United States

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

Decatur, Georgia, United States

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

Macon, Georgia, United States

Henry Ford Hospital ( Site 1535)

Detroit, Michigan, United States

KC CARE Health Center ( Site 1506)

Kansas City, Missouri, United States

ID Care ( Site 1507)

Hillsborough, New Jersey, United States

Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 1533)

Charlotte, North Carolina, United States

Regional Center for Infectious Diseases ( Site 1516)

Greensboro, North Carolina, United States

The Ohio State University ( Site 1536)

Columbus, Ohio, United States

University of Pennsylvania Perelman School of Medicine ( Site 1508)

Philadelphia, Pennsylvania, United States

Saint Hope Foundation, Inc. ( Site 1504)

Bellaire, Texas, United States

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

Dallas, Texas, United States

North Texas Infectious Diseases Consultants ( Site 1500)

Dallas, Texas, United States

Texas Center for Infectious Disease Associates ( Site 1502)

Fort Worth, Texas, United States

DCOL Center for Clinical Research ( Site 1511)

Longview, Texas, United States

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

Caba, Buenos Aires, Argentina

Fundación Huesped ( Site 3100)

CABA, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Mar del Plata ( Site 3103)

Mar del Plata, Buenos Aires, Argentina

Fundación IDEAA ( Site 3101)

Buenos Aires, Buenos Aires F.D., Argentina

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

San Miguel de Tucumán, Tucumán Province, Argentina

Spectrum Health ( Site 3307)

Vancouver, British Columbia, Canada

Gestion clinique médicale l'Actuel ( Site 3303)

Montreal, Quebec, Canada

Bordeaux University Hospital - Pellegrin ( Site 3605)

Bordeaux, Gironde, France

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

Toulouse, Haute-Garonne, France

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

Nantes, Pays de la Loire Region, France

HOPITAL DE LA CROIX ROUSSE ( Site 3613)

Lyon, Rhone, France

Hôpital Avicenne ( Site 3602)

Bobigny, Île-de-France Region, France

Hôpital Saint-Louis ( Site 3600)

Paris, Île-de-France Region, France

Hôpital Bichat - Claude-Bernard ( Site 3601)

Paris, Île-de-France Region, France

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

Guatemala City, Guatemala

MEDI-K ( Site 3803)

Guatemala City, Guatemala

CELAN,S.A ( Site 3802)

Guatemala City, Guatemala

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

León, Guanajuato, Mexico

Arké SMO S.A de C.V ( Site 4505)

Veracruz, Mexico

Wentworth Hospital ( Site 4303)

Durban, KwaZulu-Natal, South Africa

Be Part Yoluntu Centre ( Site 4300)

Mbekweni, Paarl, Western Cape, South Africa

Hospital Universitario La Paz ( Site 3404)

Madrid, Madrid, Comunidad de, Spain

Consorcio Hospital General Universitario de Valencia ( Site 3406)

Valencia, Valenciana, Comunitat, Spain

Hospital Universitari Vall d'Hebron ( Site 3402)

Barcelona, Spain

Complejo Hospitalario Virgen De La Victoria ( Site 3409)

Málaga, Spain

View Full Details on ClinicalTrials.gov

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NCT07266831