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
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Momentum Clinical Research - Darlinghurst ( Site 4260) Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| St. Vincent's Hospital ( Site 4263) Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| Momentum Clinical Research Fortitude Valley ( Site 4261) Coordinator of this site? Confirm its status | Fortitude Valley | Australia | Unknown status |
| The Alfred Hospital ( Site 4264) Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Prahran Market Clinic ( Site 4262) Coordinator of this site? Confirm its status | Prahran | Australia | Unknown status |
| University Hospital Basel-Infectiology ( Site 4402) Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Inselspital Bern-Inselspital Infektiologie ( Site 4403) Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 4404) Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 4405) Coordinator of this site? Confirm its status | Lugano | Switzerland | Unknown status |
| Ponce Medical School Foundation Inc./CAIMED Center ( Site 4301) Coordinator of this site? Confirm its status | Ponce | Puerto Rico | Unknown status |
| HOPE Clinical Research ( Site 4303) Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Clinical Research Puerto Rico ( Site 4300) Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Central Texas Clinical Research ( Site 4100) Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Prism Health North Texas, Oak Cliff Health Center ( Site 4114) Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Regional Center for Infectious Diseases ( Site 4115) Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| KC CARE Health Center ( Site 4101) Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| DCOL Center for Clinical Research ( Site 4112) Coordinator of this site? Confirm its status | Longview | United States | Unknown status |
| Orlando Immunology Center ( Site 4103) Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Zuckerberg San Francisco General Hospital and Trauma Center ( Site 4107) Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Chatham County Health Department - Chatham CARE Center ( Site 4116) Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| Georgetown University Medical Center ( Site 4106) Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Mills Clinical Research ( Site 4109) Coordinator of this site? Confirm its status | West Hollywood | United States | Unknown status |
| Triple O Research Institute ( Site 4111) Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.