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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) | Clinical Trials | Clareo Health

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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)

A Phase 2b, Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Islatravir (ISL) and Ulonivirine (ULO) Once Weekly in Adults With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily

NCT06891066•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Inclusion:
•\- 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:

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) 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.

Locations (23)

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

San Francisco, California, United States

Mills Clinical Research ( Site 4109)

West Hollywood, California, United States

Georgetown University Medical Center ( Site 4106)

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

Orlando Immunology Center ( Site 4103)

Orlando, Florida, United States

Triple O Research Institute ( Site 4111)

West Palm Beach, Florida, United States

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

Savannah, Georgia, United States

KC CARE Health Center ( Site 4101)

Kansas City, Missouri, United States

Regional Center for Infectious Diseases ( Site 4115)

Greensboro, North Carolina, United States

Central Texas Clinical Research ( Site 4100)

Austin, Texas, United States

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

Dallas, Texas, United States

Key Dates

Start Date

April 14, 2025

Primary Completion Date

August 10, 2027

Completion Date

September 30, 2031

Last Updated

October 16, 2025

Enrollment

150

ESTIMATED participants

Conditions

Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Interventions

ISL

DRUG

ULO

DRUG

BIC/FTC/TAF

DRUG