Recruiting

Phase 2

Phase 3

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

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07266831

Conditions

Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ISL

ULO

BIC/FTC/TAF

Placebo for BIC/FTC/TAF

Placebo to ISL/ULO

Study Details

Brief 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.

Conditions

Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Study ID

NCT07266831

Start date

Dec 18, 2025

Status verified date

Sep, 2026

Completion date

Dec 18, 2031

Anticipated

Primary completion date

Feb 1, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

570 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 2: ISL + ULO

Islatravir (ISL) 2mg and Ulonivirine (ULO) 200mg administered orally once weekly (qw) for 96 weeks

active comparator: Phase 2: BIC/FTC/TAF

Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) 50/200/25 mg, administered orally once daily (qd) for 96 weeks

experimental: Phase 3: ISL/ULO and Placebo to BIC/FTC/TAF

ISL/ULO fixed dose combination (2/200 mg), administered orally qw, and matching placebo to BIC/FTC/TAF administered orally qd for 96 weeks

active comparator: Phase 3: BIC/FTC/TAF and Placebo to ISL/ULO

BIC/FTC/TAF 50/200/25 mg, administered orally qd, and matching placebo to ISL/ULO administered orally qw for 96 weeks

Interventions

ISL

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

ULO

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

BIC/FTC/TAF

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

Placebo for BIC/FTC/TAF

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

Placebo to ISL/ULO

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

ISL/ULO

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

Primary outcome measure

Phase 2: Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL at Week 24 [ Time Frame: Week 24 ]
Phase 2: Percentage of Participants Who Experience an Adverse Event (AE) at Week 24 [ Time Frame: Week 24 ]
Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 24 [ Time Frame: Week 24 ]
Phase 3: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 [ Time Frame: Week 48 ]
Phase 3: Percentage of Participants Who Experience an AE at Week 48 [ Time Frame: Week 48 ]
Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 48 [ Time Frame: Week 48 ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

Ruane Clinical Research Group, Inc. ( Site 1513)

Recruiting

Los Angeles, California, United States, 90036

Contacts

Study Coordinator

323-954-0400

Vivent Health ( Site 1519)

Recruiting

Denver, Colorado, United States, 80246

Contacts

Study Coordinator

303-393-8050

Whitman-Walker Institute ( Site 1538)

Recruiting

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

Contacts

Study Coordinator

202-207-2510

Midway Immunology and Research Center ( Site 1503)

Recruiting

Ft. Pierce, Florida, United States, 34982

Contacts

Study Coordinator

772-595-9830

CAN Community Health- Miami Gardens ( Site 1549)

Recruiting

Miami Gardens, Florida, United States, 33055

Contacts

Study Coordinator

954-955-0023

Orlando Immunology Center ( Site 1501)

Recruiting

Orlando, Florida, United States, 32803

Contacts

Study Coordinator

407-374-0220

CAN Community Health ( Site 1510)

Recruiting

Sarasota, Florida, United States, 34237

Contacts

Study Coordinator

941-366-0134

Triple O Research Institute ( Site 1505)

Recruiting

West Palm Beach, Florida, United States, 33407

Contacts

Study Coordinator

561-855-7871

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

Recruiting

Decatur, Georgia, United States, 30033

Contacts

Study Coordinator

404-297-9755

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

Recruiting

Macon, Georgia, United States, 31201

Contacts

Study Coordinator

478-301-5846

Rush University Medical Center-Infectious Disease ( Site 1522)

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Study Coordinator

312-942-5865

Henry Ford Hospital ( Site 1535)

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Study Coordinator

313-916-2600

KC CARE Health Center ( Site 1506)

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Study Coordinator

816-753-5144

ID Care ( Site 1507)

Recruiting

Hillsborough, New Jersey, United States, 08844

Contacts

Study Coordinator

908-281-0221

Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 1533)

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Study Coordinator

704-468-3510

Regional Center for Infectious Diseases ( Site 1516)

Recruiting

Greensboro, North Carolina, United States, 27401

Contacts

Study Coordinator

336-832-3275

The Ohio State University ( Site 1536)

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Study Coordinator

614-293-8112

University of Pennsylvania Perelman School of Medicine ( Site 1508)

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Study Coordinator

215-349-8092

Saint Hope Foundation, Inc. ( Site 1504)

Recruiting

Bellaire, Texas, United States, 77401

Contacts

Study Coordinator

713-839-7111

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

Recruiting

Dallas, Texas, United States, 75208

Contacts

Study Coordinator

214-521-5191

Texas Center for Infectious Disease Associates ( Site 1502)

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Study Coordinator

817-348-0042

DCOL Center for Clinical Research ( Site 1511)

Recruiting

Longview, Texas, United States, 75605

Contacts

Study Coordinator

903-238-8854

Harborview Medical Center ( Site 1526)

Recruiting

Seattle, Washington, United States, 98104

Contacts

Study Coordinator

206-744-8886

Spectrum Health ( Site 3307)

Recruiting

Vancouver, British Columbia, Canada, V6Z 2T1

Contacts

Study Coordinator

6046853747

Gestion clinique médicale l'Actuel ( Site 3303)

Recruiting

Montreal, Quebec, Canada, H2L 4P9

Contacts

Study Coordinator

5145243642x2271

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-12. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.