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)

Launched by MERCK SHARP & DOHME LLC · Mar 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for adults living with HIV-1, which is a virus that can weaken the immune system. The researchers want to see how well a combination of two new medications, Islatravir (ISL) and Ulonivirine (ULO), taken once a week, works compared to an existing daily treatment called Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF). They will look at how many participants still have a high level of the virus in their blood after 24 weeks and will also monitor how safe the new treatment is and how well people can tolerate it.

To be eligible for this trial, participants must have been on the daily BIC/FTC/TAF treatment for at least six months and have a low level of the virus in their blood. They cannot have certain other health conditions, such as active hepatitis or a history of certain cancers. Participants in the trial will be closely monitored, and they will have regular check-ups to assess how the new treatment is working for them. It's important to know that the trial is currently not recruiting participants, so it won't start enrolling people just yet.

Gender

ALL

Eligibility criteria

• 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.