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)
NCT ID: NCT06891066
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2025-04-14
2031-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ISL + ULO in Group 1
In part 1 of the study, participants will receive ISL 2mg + ULO 200mg orally once a week (QW) for 48 weeks. In part 2 (2nd 48 weeks), participants will continue to receive ISL 2mg + ULO 200mg once a week till week 96.
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 in Group 2
In part 1 of the study, participants will receive BIC 50mg/FTC 200mg/TAF 25mg orally once daily (QD) for 48 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.
ISL + ULO in Group 2
In part 2 of the study, participants previously on BIC/FTC/TAF (for the 1st 48 weeks, or part 1) will switch to ISL + ULO, to week 96.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion:
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
Countries
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Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-8591B-060
Identifier Type: OTHER
Identifier Source: secondary_id
8591B-060
Identifier Type: -
Identifier Source: org_study_id
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