ACTIVE_NOT_RECRUITING

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)

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Conditions

Human Immunodeficiency Virus Type 1 (HIV-1) InfectionHIV-1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-04-14
Study Completion:2027-09-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06891066

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

Zuckerberg San Francisco General Hospital and Trauma Center ( Site 4107)
San Francisco, California, 94110
United States
Mills Clinical Research ( Site 4109)
West Hollywood, California, 90046
United States
Georgetown University Medical Center ( Site 4106)
Washington, District of Columbia, 20007
United States
Orlando Immunology Center ( Site 4103)
Orlando, Florida, 32803
United States
Triple O Research Institute ( Site 4111)
West Palm Beach, Florida, 33407
United States
Chatham County Health Department - Chatham CARE Center ( Site 4116)
Savannah, Georgia, 31401
United States
KC CARE Health Center ( Site 4101)
Kansas City, Missouri, 64111
United States
Regional Center for Infectious Diseases ( Site 4115)
Greensboro, North Carolina, 27401
United States
Central Texas Clinical Research ( Site 4100)
Austin, Texas, 78705
United States
Prism Health North Texas, Oak Cliff Health Center ( Site 4114)
Dallas, Texas, 75208
United States
DCOL Center for Clinical Research ( Site 4112)
Longview, Texas, 75605
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-14
Study Completion Date2027-09-24

Study Record Updates

Study Start Date2025-04-14
Study Completion Date2027-09-24

Terms related to this study

Keywords Provided by Researchers

  • HIV-1

Additional Relevant MeSH Terms

  • Human Immunodeficiency Virus Type 1 (HIV-1) Infection