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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)

NCT06891066

Active Not RecruitingPhase 2

Sponsor: Merck Sharp & Dohme LLC

Conditions: Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Interventions: ISL, ULO, BIC/FTC/TAF

Countries: United States, Australia, Puerto Rico, Switzerland

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (23)

San Francisco, California, United States
West Hollywood, California, United States
Washington D.C., District of Columbia, United States
Orlando, Florida, United States
West Palm Beach, Florida, United States
Savannah, Georgia, United States
Kansas City, Missouri, United States
Greensboro, North Carolina, United States
Austin, Texas, United States
Dallas, Texas, United States
Longview, Texas, United States
Darlinghurst, New South Wales, Australia
Darlinghurst, New South Wales, Australia
Fortitude Valley, Queensland, Australia
Melbourne, Victoria, Australia
Prahran, Victoria, Australia
Ponce, Puerto Rico
San Juan, Puerto Rico
San Juan, Puerto Rico
Basel, Canton of Basel-City, Switzerland
Bern, Canton of Bern, Switzerland
Geneva, Canton of Geneva, Switzerland
Lugano, Canton Ticino, Switzerland