A Study of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly (QW) in Virologically Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8591B-060)

Last updated: May 10, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Aids And Aids Related Infections

Hiv/aids

Hiv Infections

Treatment

ISL

ULO

BIC/FTC/TAF

Clinical Study ID

NCT06891066
8591B-060
MK-8591B-060
  • Ages > 18
  • All Genders

Study Summary

Investigators are trying to find better treatments for people with HIV-1. In this clinical study, investigators want to see how well a new treatment called ISL+ULO, taken once a week, works compared to an existing treatment called BIC/FTC/TAF, which is taken every day. Investigators will check how many people still have a high level of the virus in their blood after 24 weeks. The investigators also want to understand if the new treatment, MK-8591B, is safe and how well people can handle it.

Eligibility Criteria

Inclusion

Inclusion:

The main inclusion criteria include but are not limited to the following:

  • Has been receiving Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) therapy with documented viral suppression [Human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL] for ≥6 months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen.

Exclusion:

The main exclusion criteria include but are not limited to the following:

  • 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) coinfection.

  • Has hepatitis B virus (HBV) coinfection.

  • 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

Total Participants: 150
Treatment Group(s): 3
Primary Treatment: ISL
Phase: 2
Study Start date:
April 14, 2025
Estimated Completion Date:
September 24, 2027

Connect with a study center

  • Momentum Clinical Research - Darlinghurst ( Site 4260)

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • Momentum Clinical Research Fortitude Valley ( Site 4261)

    Fortitude Valley, Queensland 4006
    Australia

    Active - Recruiting

  • Prahran Market Clinic ( Site 4262)

    Prahran, Victoria 3181
    Australia

    Active - Recruiting

  • Ponce Medical School Foundation Inc./CAIMED Center ( Site 4301)

    Ponce, 00716
    Puerto Rico

    Active - Recruiting

  • Clinical Research Puerto Rico ( Site 4300)

    San Juan, 00909
    Puerto Rico

    Active - Recruiting

  • HOPE Clinical Research ( Site 4303)

    San Juan, 00909
    Puerto Rico

    Active - Recruiting

  • University Hospital Basel-Infectiology ( Site 4402)

    Basel, Basel-Stadt 4031
    Switzerland

    Active - Recruiting

  • Inselspital Bern-Inselspital Infektiologie ( Site 4403)

    Bern, Berne 3010
    Switzerland

    Active - Recruiting

  • Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 4404)

    Genève, Geneve 1205
    Switzerland

    Active - Recruiting

  • Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 4405)

    Lugano, Ticino 6900
    Switzerland

    Active - Recruiting

  • Zuckerberg San Francisco General Hospital and Trauma Center ( Site 4107)

    San Francisco, California 94110
    United States

    Active - Recruiting

  • Mills Clinical Research ( Site 4109)

    West Hollywood, California 90046
    United States

    Active - Recruiting

  • Georgetown University Medical Center ( Site 4106)

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • Orlando Immunology Center ( Site 4103)

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Triple O Research Institute ( Site 4111)

    West Palm Beach, Florida 33407
    United States

    Active - Recruiting

  • Chatham County Health Department - Chatham CARE Center ( Site 4116)

    Savannah, Georgia 31401
    United States

    Active - Recruiting

  • KC CARE Health Center ( Site 4101)

    Kansas City, Missouri 64111
    United States

    Active - Recruiting

  • Regional Center for Infectious Diseases ( Site 4115)

    Greensboro, North Carolina 27401
    United States

    Active - Recruiting

  • Central Texas Clinical Research ( Site 4100)

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Prism Health North Texas, Oak Cliff Health Center ( Site 4114)

    Dallas, Texas 75208
    United States

    Active - Recruiting

  • DCOL Center for Clinical Research ( Site 4112)

    Longview, Texas 75605
    United States

    Active - Recruiting

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