Back to Trials
NCT07266831PHASE2, PHASE3Recruiting

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

Merck Sharp & Dohme LLC

Start Date

12/18/2025

Completion Date

4/3/2030

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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

ISL

DRUG

ULO

DRUG

BIC/FTC/TAF

DRUG

Placebo for BIC/FTC/TAF

DRUG

Placebo to ISL/ULO

DRUG

ISL/ULO

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Locations

Ruane Clinical Research Group, Inc. ( Site 1513)

Los Angeles, California 90036

United States

Vivent Health ( Site 1519)

Denver, Colorado 80246

United States

Whitman-Walker Institute ( Site 1538)

Washington D.C., District of Columbia 20032

United States

Midway Immunology and Research Center ( Site 1503)

Ft. Pierce, Florida 34982

United States

CAN Community Health- Miami Gardens ( Site 1549)

Miami Gardens, Florida 33055

United States

Orlando Immunology Center ( Site 1501)

Orlando, Florida 32803

United States

CAN Community Health ( Site 1510)

Sarasota, Florida 34237

United States

Triple O Research Institute ( Site 1505)

West Palm Beach, Florida 33407

United States

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

Decatur, Georgia 30033

United States

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

Macon, Georgia 31201

United States

Rush University Medical Center-Infectious Disease ( Site 1522)

Chicago, Illinois 60612

United States

Henry Ford Hospital ( Site 1535)

Detroit, Michigan 48202

United States

KC CARE Health Center ( Site 1506)

Kansas City, Missouri 64111

United States

ID Care ( Site 1507)

Hillsborough, New Jersey 08844

United States

Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 1533)

Charlotte, North Carolina 28204

United States

Regional Center for Infectious Diseases ( Site 1516)

Greensboro, North Carolina 27401

United States

The Ohio State University ( Site 1536)

Columbus, Ohio 43210

United States

University of Pennsylvania Perelman School of Medicine ( Site 1508)

Philadelphia, Pennsylvania 19104

United States

Saint Hope Foundation, Inc. ( Site 1504)

Bellaire, Texas 77401

United States

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

Dallas, Texas 75208

United States

North Texas Infectious Diseases Consultants ( Site 1500)

Dallas, Texas 75246

United States

Texas Center for Infectious Disease Associates ( Site 1502)

Fort Worth, Texas 76104

United States

DCOL Center for Clinical Research ( Site 1511)

Longview, Texas 75605

United States

Harborview Medical Center ( Site 1526)

Seattle, Washington 98104

United States

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

Caba, Buenos Aires C1425AGC

Argentina

Fundación Huesped ( Site 3100)

CABA, Buenos Aires C1427CEA

Argentina

Instituto de Investigaciones Clinicas Mar del Plata ( Site 3103)

Mar del Plata, Buenos Aires B7600FZN

Argentina

Fundación IDEAA ( Site 3101)

Buenos Aires, Buenos Aires F.D. C1405CKC

Argentina

Instituto CAICI SRL ( Site 3106)

Rosario, Santa Fe Province S2000PBJ

Argentina

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

San Miguel de Tucumán, Tucumán Province T4000IHE

Argentina

Spectrum Health ( Site 3307)

Vancouver, British Columbia V6Z 2T1

Canada

Gestion clinique médicale l'Actuel ( Site 3303)

Montreal, Quebec H2L 4P9

Canada

Biomedica Research Group ( Site 4201)

Santiago, Region M. de Santiago 7500710

Chile

Clínica Universidad de Los Andes ( Site 4207)

Santiago, Region M. de Santiago 7620157

Chile

Espacio Eme ( Site 4202)

Santiago, Region M. de Santiago 7770086

Chile

Bordeaux University Hospital - Pellegrin ( Site 3605)

Bordeaux, Gironde 33000

France

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

Toulouse, Haute-Garonne 31059

France

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

Nantes, Pays de la Loire Region 44093

France

HOPITAL DE LA CROIX ROUSSE ( Site 3613)

Lyon, Rhone 69317

France

Hôpital Avicenne ( Site 3602)

Bobigny, Île-de-France Region 93000

France

Hôpital Saint-Louis ( Site 3600)

Paris, Île-de-France Region 75010

France

Hôpital Bichat - Claude-Bernard ( Site 3601)

Paris, Île-de-France Region 75018

France

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

Guatemala City, 01009

Guatemala

MEDI-K ( Site 3803)

Guatemala City, 01009

Guatemala

CELAN,S.A ( Site 3802)

Guatemala City, 01010

Guatemala

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

León, Guanajuato 37000

Mexico

Josha Research ( Site 4302)

Bloemfontein, Free State 9301

South Africa

Wentworth Hospital ( Site 4303)

Durban, KwaZulu-Natal 4052

South Africa

Be Part Yoluntu Centre ( Site 4300)

Mbekweni, Paarl, Western Cape 7646

South Africa

Hospital Universitario La Paz ( Site 3404)

Madrid, Madrid, Comunidad de 28029

Spain

Consorcio Hospital General Universitario de Valencia ( Site 3406)

Valencia, Valenciana, Comunitat 46014

Spain

Hospital Universitari Vall d'Hebron ( Site 3402)

Barcelona, 08035

Spain

HOSPITAL CLÍNIC DE BARCELONA ( Site 3400)

Barcelona, 08036

Spain

Hospital Universitario 12 de Octubre ( Site 3405)

Madrid, 28041

Spain

Complejo Hospitalario Virgen De La Victoria ( Site 3409)

Málaga, 29010

Spain