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Active (not recruiting) Phase 2 NCT06891066

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)

Phase 2 – studying effectiveness and dosage
Conditions: Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
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.
Who can participate
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 4
Australia (1)
Momentum Clinical Research - Darlinghurst ( Site 4260)
Darlinghurst , New South Wales
Puerto Rico (1)
Ponce Medical School Foundation Inc./CAIMED Center ( Site 4301)
Ponce
Switzerland (1)
University Hospital Basel-Infectiology ( Site 4402)
Basel , Canton of Basel-City
United States (1)
Zuckerberg San Francisco General Hospital and Trauma Center ( Site 4107)
San Francisco , California
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
14.04.2025
Completion date
30.09.2031
Registry ID
NCT06891066
Source
anzctr
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