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)

Description

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.

Conditions

Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Study Overview

Study Details

Study overview

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.

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

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)

Condition
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Intervention / Treatment

-

Contacts and Locations

San Francisco

Zuckerberg San Francisco General Hospital and Trauma Center ( Site 4107), San Francisco, California, United States, 94110

West Hollywood

Mills Clinical Research ( Site 4109), West Hollywood, California, United States, 90046

Washington

Georgetown University Medical Center ( Site 4106), Washington, District of Columbia, United States, 20007

Orlando

Orlando Immunology Center ( Site 4103), Orlando, Florida, United States, 32803

West Palm Beach

Triple O Research Institute ( Site 4111), West Palm Beach, Florida, United States, 33407

Savannah

Chatham County Health Department - Chatham CARE Center ( Site 4116), Savannah, Georgia, United States, 31401

Kansas City

KC CARE Health Center ( Site 4101), Kansas City, Missouri, United States, 64111

Greensboro

Regional Center for Infectious Diseases ( Site 4115), Greensboro, North Carolina, United States, 27401

Austin

Central Texas Clinical Research ( Site 4100), Austin, Texas, United States, 78705

Dallas

Prism Health North Texas, Oak Cliff Health Center ( Site 4114), Dallas, Texas, United States, 75208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Merck Sharp & Dohme LLC,

    Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

    Study Record Dates

    2027-09-24