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 study on HIV/AIDS Immunodeficiency

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

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

Keywords

Human Immunodeficiency Virus Type 1 (HIV-1) Infection, HIV-1, Acquired Immunodeficiency Syndrome, HIV Infections, Immunologic Deficiency Syndromes, Islatravir, ISL, ULO, BIC/FTC/TAF

Eligibility

For people ages 18 years and up

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.

Locations

  • Zuckerberg San Francisco General Hospital and Trauma Center ( Site 4107) accepting new patients
    San Francisco California 94110 United States
  • Mills Clinical Research ( Site 4109) accepting new patients
    West Hollywood California 90046 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme LLC
Links
Merck Clinical Trials Information
ID
NCT06891066
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated
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