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

NCT ID: NCT07266831

Last Updated: 2026-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

570 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-18

Study Completion Date

2030-04-25

Brief Summary

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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.

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Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1

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Detailed Description

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Conditions

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Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Phase 2: no masking Phase 3: Participant, Sponsor, and Investigator are masked

Study Groups

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Phase 2: ISL + ULO

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

Group Type EXPERIMENTAL

ISL

Intervention Type DRUG

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

ULO

Intervention Type DRUG

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

Phase 2: BIC/FTC/TAF

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

Group Type ACTIVE_COMPARATOR

BIC/FTC/TAF

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Placebo for BIC/FTC/TAF

Intervention Type DRUG

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

ISL/ULO

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

BIC/FTC/TAF

Intervention Type DRUG

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

Placebo to ISL/ULO

Intervention Type DRUG

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

Interventions

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ISL

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

Intervention Type DRUG

ULO

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

Intervention Type DRUG

BIC/FTC/TAF

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

Intervention Type DRUG

Placebo for BIC/FTC/TAF

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

Intervention Type DRUG

Placebo to ISL/ULO

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

Intervention Type DRUG

ISL/ULO

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

Intervention Type DRUG

Other Intervention Names

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islatravir MK-8591 ulonivirine MK-8507 bictegravir/emtricitabine/tenofovir alafenamide BIKTARVY® MK-8591B

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Vivent Health ( Site 1519)

Denver, Colorado, United States

Site Status RECRUITING

Whitman-Walker Institute ( Site 1538)

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

Site Status RECRUITING

Midway Immunology and Research Center ( Site 1503)

Ft. Pierce, Florida, United States

Site Status RECRUITING

CAN Community Health- Miami Gardens ( Site 1549)

Miami, Florida, United States

Site Status RECRUITING

Orlando Immunology Center ( Site 1501)

Orlando, Florida, United States

Site Status RECRUITING

CAN Community Health ( Site 1510)

Sarasota, Florida, United States

Site Status RECRUITING

Triple O Research Institute ( Site 1505)

West Palm Beach, Florida, United States

Site Status RECRUITING

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

Decatur, Georgia, United States

Site Status RECRUITING

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

Macon, Georgia, United States

Site Status RECRUITING

KC CARE Health Center ( Site 1506)

Kansas City, Missouri, United States

Site Status RECRUITING

ID Care ( Site 1507)

Hillsborough, New Jersey, United States

Site Status RECRUITING

Regional Center for Infectious Diseases ( Site 1516)

Greensboro, North Carolina, United States

Site Status RECRUITING

The Ohio State University ( Site 1536)

Columbus, Ohio, United States

Site Status RECRUITING

University of Pennsylvania Perelman School of Medicine ( Site 1508)

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Saint Hope Foundation, Inc. ( Site 1504)

Bellaire, Texas, United States

Site Status RECRUITING

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

Dallas, Texas, United States

Site Status RECRUITING

North Texas Infectious Diseases Consultants ( Site 1500)

Dallas, Texas, United States

Site Status RECRUITING

Texas Center for Infectious Disease Associates ( Site 1502)

Fort Worth, Texas, United States

Site Status RECRUITING

DCOL Center for Clinical Research ( Site 1511)

Longview, Texas, United States

Site Status RECRUITING

Spectrum Health ( Site 3307)

Vancouver, British Columbia, Canada

Site Status RECRUITING

Gestion clinique médicale l'Actuel ( Site 3303)

Montreal, Quebec, Canada

Site Status RECRUITING

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

Guatemala City, , Guatemala

Site Status RECRUITING

MEDI-K ( Site 3803)

Guatemala City, , Guatemala

Site Status RECRUITING

Countries

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United States Canada Guatemala

Central Contacts

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Toll Free Number

Role: CONTACT

[email protected]
1-888-577-8839

Facility Contacts

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Study Coordinator

Role: primary

303-393-8050

Study Coordinator

Role: primary

202-207-2510

Study Coordinator

Role: primary

772-595-9830

Study Coordinator

Role: primary

954-955-0023

Study Coordinator

Role: primary

407-374-0220

Study Coordinator

Role: primary

941-366-0134

Study Coordinator

Role: primary

561-855-7871

Study Coordinator

Role: primary

404-297-9755

Study Coordinator

Role: primary

478-301-5846

Study Coordinator

Role: primary

816-753-5144

Study Coordinator

Role: primary

908-281-0221

Study Coordinator

Role: primary

336-832-3275

Study Coordinator

Role: primary

614-293-8112

Study Coordinator

Role: primary

215-349-8092

Study Coordinator

Role: primary

713-839-7111

Study Coordinator

Role: primary

214-521-5191

Study Coordinator

Role: primary

214-276-5627

Study Coordinator

Role: primary

817-348-0042

Study Coordinator

Role: primary

903-238-8854

Study Coordinator

Role: primary

6046853747

Study Coordinator

Role: primary

5145243642x2271

Study Coordinator

Role: primary

+50223196600

Study Coordinator

Role: primary

+50222912323

Related Links

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http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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U1111-1323-4689

Identifier Type: REGISTRY

Identifier Source: secondary_id

2025-522519-40

Identifier Type: REGISTRY

Identifier Source: secondary_id

MK-8591B-062

Identifier Type: OTHER

Identifier Source: secondary_id

8591B-062

Identifier Type: -

Identifier Source: org_study_id

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