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NCT06891066Active, not recruitingPhase 2

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)

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

Source: ClinicalTrials.gov · Last updated 16 Oct 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
150 (estimated)
First submitted
17 Mar 2025
Start date
14 Apr 2025
Primary completion date
10 Aug 2027
Lead sponsor
Merck Sharp & Dohme LLC
Diseases
HIV
NCT number
NCT06891066

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 150
  • From 14 Apr 2025 to the primary completion date, 10 Aug 2027
  • 23 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Momentum Clinical Research - Darlinghurst ( Site 4260)
Coordinator of this site? Confirm its status
DarlinghurstAustraliaUnknown status
St. Vincent's Hospital ( Site 4263)
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DarlinghurstAustraliaUnknown status
Momentum Clinical Research Fortitude Valley ( Site 4261)
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Fortitude ValleyAustraliaUnknown status
The Alfred Hospital ( Site 4264)
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MelbourneAustraliaUnknown status
Prahran Market Clinic ( Site 4262)
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PrahranAustraliaUnknown status
University Hospital Basel-Infectiology ( Site 4402)
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BaselSwitzerlandUnknown status
Inselspital Bern-Inselspital Infektiologie ( Site 4403)
Coordinator of this site? Confirm its status
BernSwitzerlandUnknown status
Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 4404)
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GenevaSwitzerlandUnknown status
Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 4405)
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LuganoSwitzerlandUnknown status
Ponce Medical School Foundation Inc./CAIMED Center ( Site 4301)
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PoncePuerto RicoUnknown status
HOPE Clinical Research ( Site 4303)
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San JuanPuerto RicoUnknown status
Clinical Research Puerto Rico ( Site 4300)
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San JuanPuerto RicoUnknown status
Central Texas Clinical Research ( Site 4100)
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AustinUnited StatesUnknown status
Prism Health North Texas, Oak Cliff Health Center ( Site 4114)
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DallasUnited StatesUnknown status
Regional Center for Infectious Diseases ( Site 4115)
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GreensboroUnited StatesUnknown status
KC CARE Health Center ( Site 4101)
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Kansas CityUnited StatesUnknown status
DCOL Center for Clinical Research ( Site 4112)
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LongviewUnited StatesUnknown status
Orlando Immunology Center ( Site 4103)
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OrlandoUnited StatesUnknown status
Zuckerberg San Francisco General Hospital and Trauma Center ( Site 4107)
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San FranciscoUnited StatesUnknown status
Chatham County Health Department - Chatham CARE Center ( Site 4116)
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SavannahUnited StatesUnknown status
Georgetown University Medical Center ( Site 4106)
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Washington D.C.United StatesUnknown status
Mills Clinical Research ( Site 4109)
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West HollywoodUnited StatesUnknown status
Triple O Research Institute ( Site 4111)
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West Palm BeachUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.