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Phase 2Recruiting

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

Sponsored by Merck Sharp & Dohme LLC

About this study

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.

Where this study is enrolling (23)

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

    Los Angeles, California

    Call 323-954-0400

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  • Vivent Health ( Site 1519)

    Denver, Colorado

    Call 303-393-8050

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  • Whitman-Walker Institute ( Site 1538)

    Washington D.C., District of Columbia

    Call 202-207-2510

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  • Orlando Immunology Center ( Site 1501)

    Orlando, Florida

    Call 407-374-0220

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  • CAN Community Health- Miami Gardens ( Site 1549)

    Miami Gardens, Florida

    Call 954-955-0023

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Show all 23 locations

  • CAN Community Health ( Site 1510)

    Sarasota, Florida

    Call 941-366-0134

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  • Midway Immunology and Research Center ( Site 1503)

    Ft. Pierce, Florida

    Call 772-595-9830

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  • Triple O Research Institute ( Site 1505)

    West Palm Beach, Florida

    Call 561-855-7871

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

    Macon, Georgia

    Call 478-301-5846

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

    Decatur, Georgia

    Call (888) 220-6432

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

    Chicago, Illinois

    I'm interested

  • Henry Ford Hospital ( Site 1535)

    Detroit, Michigan

    Call 313-916-2600

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  • KC CARE Health Center ( Site 1506)

    Kansas City, Missouri

    Call 816-753-5144

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  • ID Care ( Site 1507)

    Hillsborough, New Jersey

    Call 908-281-0221

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

    Charlotte, North Carolina

    Call 704-468-3510

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  • Regional Center for Infectious Diseases ( Site 1516)

    Greensboro, North Carolina

    Call 336-832-3275

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  • The Ohio State University ( Site 1536)

    Columbus, Ohio

    Call 614-293-8112

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

    Philadelphia, Pennsylvania

    I'm interested

  • Saint Hope Foundation, Inc. ( Site 1504)

    Bellaire, Texas

    Call 713-839-7111

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

    Dallas, Texas

    Call 214-521-5191

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  • Texas Center for Infectious Disease Associates ( Site 1502)

    Fort Worth, Texas

    Call 817-348-0042

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  • DCOL Center for Clinical Research ( Site 1511)

    Longview, Texas

    Call 903-238-8854

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  • Harborview Medical Center ( Site 1526)

    Seattle, Washington

    Call 206-744-8886

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Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.