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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
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-04-14
Completion Date
2031-09-30
Last Updated
2025-10-16
Healthy Volunteers
No
Interventions
ISL
ISL 1mg oral capsule will be administered as 2mg orally (each capsule 1mg) as part of ISL and ULO combination to group 1 participants for 96 weeks and for group 2 participants in part 2 of the study from 49 to 96 weeks.
ULO
ULO 100mg oral tablet will be administered as 200mg (2 tablets) orally as part of ISL and ULO combination to group 1 participants for 96 weeks and for group 2 participants in part 2 of the study from 49 to 96 weeks.
BIC/FTC/TAF
BIC 50mg oral tablet/FTC 200mg oral tablet/TAF 25 mg oral tablet administered orally to group 2 participants for 48 weeks in part 1 of the study.
Locations (23)
Zuckerberg San Francisco General Hospital and Trauma Center ( Site 4107)
San Francisco, California, United States
Mills Clinical Research ( Site 4109)
West Hollywood, California, United States
Georgetown University Medical Center ( Site 4106)
Washington D.C., District of Columbia, United States
Orlando Immunology Center ( Site 4103)
Orlando, Florida, United States
Triple O Research Institute ( Site 4111)
West Palm Beach, Florida, United States
Chatham County Health Department - Chatham CARE Center ( Site 4116)
Savannah, Georgia, United States
KC CARE Health Center ( Site 4101)
Kansas City, Missouri, United States
Regional Center for Infectious Diseases ( Site 4115)
Greensboro, North Carolina, United States
Central Texas Clinical Research ( Site 4100)
Austin, Texas, United States
Prism Health North Texas, Oak Cliff Health Center ( Site 4114)
Dallas, Texas, United States
DCOL Center for Clinical Research ( Site 4112)
Longview, Texas, United States
Momentum Clinical Research - Darlinghurst ( Site 4260)
Darlinghurst, New South Wales, Australia
St. Vincent's Hospital ( Site 4263)
Darlinghurst, New South Wales, Australia
Momentum Clinical Research Fortitude Valley ( Site 4261)
Fortitude Valley, Queensland, Australia
The Alfred Hospital ( Site 4264)
Melbourne, Victoria, Australia
Prahran Market Clinic ( Site 4262)
Prahran, Victoria, Australia
Ponce Medical School Foundation Inc./CAIMED Center ( Site 4301)
Ponce, Puerto Rico
Clinical Research Puerto Rico ( Site 4300)
San Juan, Puerto Rico
HOPE Clinical Research ( Site 4303)
San Juan, Puerto Rico
University Hospital Basel-Infectiology ( Site 4402)
Basel, Canton of Basel-City, Switzerland
Inselspital Bern-Inselspital Infektiologie ( Site 4403)
Bern, Canton of Bern, Switzerland
Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 4404)
Geneva, Canton of Geneva, Switzerland
Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 4405)
Lugano, Canton Ticino, Switzerland