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RecruitingPhase 2/Phase 3

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 · NCT07266831

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2, Phase 3
Target enrollment
570
US sites recruiting
23
Study start
December 18, 2025
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: ISL; ULO; BIC/FTC/TAF; Placebo for BIC/FTC/TAF; Placebo to ISL/ULO; ISL/ULO

Conditions: Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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 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.

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.

Recruiting US locations

  • Ruane Clinical Research Group, Inc. ( Site 1513)

    Los Angeles, CA 90036

    Site contact: Study Coordinator · 323-954-0400

  • Vivent Health ( Site 1519)

    Denver, CO 80246

    Site contact: Study Coordinator · 303-393-8050

  • Whitman-Walker Institute ( Site 1538)

    Washington D.C., DC 20032

    Site contact: Study Coordinator · 202-207-2510

  • Midway Immunology and Research Center ( Site 1503)

    Ft. Pierce, FL 34982

    Site contact: Study Coordinator · 772-595-9830

  • CAN Community Health- Miami Gardens ( Site 1549)

    Miami Gardens, FL 33055

    Site contact: Study Coordinator · 954-955-0023

  • Orlando Immunology Center ( Site 1501)

    Orlando, FL 32803

    Site contact: Study Coordinator · 407-374-0220

  • CAN Community Health ( Site 1510)

    Sarasota, FL 34237

    Site contact: Study Coordinator · 941-366-0134

  • Triple O Research Institute ( Site 1505)

    West Palm Beach, FL 33407

    Site contact: Study Coordinator · 561-855-7871

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

    Decatur, GA 30033

    Site contact: Study Coordinator · 404-297-9755

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

    Macon, GA 31201

    Site contact: Study Coordinator · 478-301-5846

  • Rush University Medical Center-Infectious Disease ( Site 1522)

    Chicago, IL 60612

    Site contact: Study Coordinator · 312-942-5865

  • Henry Ford Hospital ( Site 1535)

    Detroit, MI 48202

    Site contact: Study Coordinator · 313-916-2600

  • KC CARE Health Center ( Site 1506)

    Kansas City, MO 64111

    Site contact: Study Coordinator · 816-753-5144

  • ID Care ( Site 1507)

    Hillsborough, NJ 08844

    Site contact: Study Coordinator · 908-281-0221

  • Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 1533)

    Charlotte, NC 28204

    Site contact: Study Coordinator · 704-468-3510

  • Regional Center for Infectious Diseases ( Site 1516)

    Greensboro, NC 27401

    Site contact: Study Coordinator · 336-832-3275

  • The Ohio State University ( Site 1536)

    Columbus, OH 43210

    Site contact: Study Coordinator · 614-293-8112

  • University of Pennsylvania Perelman School of Medicine ( Site 1508)

    Philadelphia, PA 19104

    Site contact: Study Coordinator · 215-349-8092

  • Saint Hope Foundation, Inc. ( Site 1504)

    Bellaire, TX 77401

    Site contact: Study Coordinator · 713-839-7111

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

    Dallas, TX 75208

    Site contact: Study Coordinator · 214-521-5191

  • Texas Center for Infectious Disease Associates ( Site 1502)

    Fort Worth, TX 76104

    Site contact: Study Coordinator · 817-348-0042

  • DCOL Center for Clinical Research ( Site 1511)

    Longview, TX 75605

    Site contact: Study Coordinator · 903-238-8854

  • Harborview Medical Center ( Site 1526)

    Seattle, WA 98104

    Site contact: Study Coordinator · 206-744-8886

Study contacts (from the official record)

  • Toll Free Number · 1-888-577-8839 · Trialsites@msd.com
A Clinical Study of Islatravir and Ulonivirine for People With… (NCT07266831) | Bored Studies