Clinical trial 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)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Keywords: HIV-1
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-03-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With HIV-1 RNA ≥50 copies/mL at Week 24
timeFrame: Week 24
measure: Percentage of Participants who Experience an Adverse Event (AE)
timeFrame: Up to ~ 96 weeks
measure: Percentage of Participants Discontinuing Study Treatment due to AEs
timeFrame: Up to ~ 96 weeks
Secondary outcomes:
measure: Percentage of Participants With HIV-1 RNA ≥50 copies/mL at Week 48
timeFrame: Week 48
measure: Percentage of Participants With HIV-1 RNA <50 copies/mL at Week 24
timeFrame: Week 24
measure: Percentage of Participants With HIV-1 RNA <50 copies/mL at Week 48
timeFrame: Week 48
measure: Percentage of Participants With HIV-1 RNA <200 copies/mL at Week 24
timeFrame: Week 24
measure: Percentage of Participants With HIV-1 RNA <200 copies/mL at Week 48
timeFrame: Week 48
measure: Percentage of Participants With HIV-1 RNA ≥50 copies/mL at Week 96
timeFrame: Week 96
measure: Percentage of Participants With HIV-1 RNA <50 copies/mL at Week 96
timeFrame: Week 96
measure: Percentage of Participants With HIV-1 RNA <200 copies/mL at Week 96
timeFrame: Week 96
measure: Mean Change From Baseline in CD4+ T-cell Count at Week 24
timeFrame: Week 24
measure: Mean Change From Baseline in CD4+ T-cell Count at Week 48
timeFrame: Week 48
measure: Mean Change From Baseline in CD4+ T-cell Count at Week 96
timeFrame: Week 96
measure: Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention at Week 48
timeFrame: Week 48
measure: Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention at Week 96
timeFrame: Week 96
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital and Trauma Center ( Site 4107)
state: California
city: West Hollywood
country: United States
facility: Mills Clinical Research ( Site 4109)
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center ( Site 4106)
state: District of Columbia
city: Orlando
country: United States
facility: Orlando Immunology Center ( Site 4103)
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Research Institute ( Site 4111)
state: Florida
city: Savannah
country: United States
facility: Chatham County Health Department - Chatham CARE Center ( Site 4116)
state: Georgia
city: Kansas City
country: United States
facility: KC CARE Health Center ( Site 4101)
state: Missouri
city: Greensboro
country: United States
facility: Regional Center for Infectious Diseases ( Site 4115)
state: North Carolina
city: Austin
country: United States
facility: Central Texas Clinical Research ( Site 4100)
state: Texas
city: Dallas
country: United States
facility: Prism Health North Texas, Oak Cliff Health Center ( Site 4114)
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research ( Site 4112)
state: Texas
city: Darlinghurst
country: Australia
facility: Momentum Clinical Research - Darlinghurst ( Site 4260)
state: New South Wales
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital ( Site 4263)
state: New South Wales
city: Fortitude Valley
country: Australia
facility: Momentum Clinical Research Fortitude Valley ( Site 4261)
state: Queensland
city: Melbourne
country: Australia
facility: The Alfred Hospital ( Site 4264)
state: Victoria
city: Prahran
country: Australia
facility: Prahran Market Clinic ( Site 4262)
state: Victoria
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation Inc./CAIMED Center ( Site 4301)
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico ( Site 4300)
city: San Juan
country: Puerto Rico
facility: HOPE Clinical Research ( Site 4303)
city: Basel
country: Switzerland
facility: University Hospital Basel-Infectiology ( Site 4402)
state: Basel-Stadt
city: Bern
country: Switzerland
facility: Inselspital Bern-Inselspital Infektiologie ( Site 4403)
state: Berne
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 4404)
state: Geneve
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 4405)
state: Ticino
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: