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NCT06891066 | NOT YET RECRUITING | Human Immunodeficiency Virus Type 1 (HIV-1) Infection

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)
Sponsor:

Merck Sharp & Dohme LLC

Brief 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.

Condition or disease

Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Intervention/treatment

ISL

ULO

BIC/FTC/TAF

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-04-21
Estimated Primary Completion Date : 2027-10-01
Estimated Study Completion Date : 2027-10-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
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)

Location Details

NCT06891066

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