Dose Ranging, Switch Study of Islatravir (MK-8591) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]
NCT ID: NCT04564547
Last Updated: 2026-01-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
161 participants
INTERVENTIONAL
2021-03-09
2025-01-30
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
TRIPLE
In the unblinded safety monitoring period, participants, investigators, and Sponsor personnel are unblinded as to the participant's original randomized intervention group.
Study Groups
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Group 1: ISL 20 mg + Ulonivirine 100 mg
Participants receive ISL 20 mg + ulonivirine 100 mg once weekly (QW) and placebo to BIC/FTC/TAF once daily (QD). Following study-wide discontinuation of study intervention, participants may have entered the optional unblinded safety monitoring period and received standard of care non-study ART.
Islatravir
ISL capsule taken by mouth.
Ulonivirine
Ulonivirine tablet taken by mouth.
Placebo to Ulonivirine
Placebo tablet matched to ulonivirine taken by mouth.
Placebo to BIC/FTC/TAF
Placebo tablet matched to BIC/FTC/TAF taken by mouth.
Group 2: ISL 20 mg + Ulonivirine 200 mg
Participants receive ISL 20 mg + ulonivirine 200 mg QW and placebo to BIC/FTC/TAF QD. Following study-wide discontinuation of study intervention, participants may have entered the optional unblinded safety monitoring period and received standard of care non-study ART.
Islatravir
ISL capsule taken by mouth.
Ulonivirine
Ulonivirine tablet taken by mouth.
Placebo to Ulonivirine
Placebo tablet matched to ulonivirine taken by mouth.
Placebo to BIC/FTC/TAF
Placebo tablet matched to BIC/FTC/TAF taken by mouth.
Group 3: ISL 20 mg + Ulonivirine 400 mg
Participants receive ISL 20 mg + ulonivirine 400 mg QW and placebo to BIC/FTC/TAF QD. Following study-wide discontinuation of study intervention, participants may have entered the optional unblinded safety monitoring period and received standard of care non-study ART.
Islatravir
ISL capsule taken by mouth.
Ulonivirine
Ulonivirine tablet taken by mouth.
Placebo to BIC/FTC/TAF
Placebo tablet matched to BIC/FTC/TAF taken by mouth.
Group 4: BIC/FTC/TAF
Participants receive placebo to ISL + placebo to ulonivirine QW and BIC/FTC/TAF 50 mg/200 mg/25 mg QD.
BIC/FTC/TAF
BIC/FTC/TAF tablet taken by mouth.
Placebo to ISL
Placebo capsule matched to ISL taken by mouth.
Placebo to Ulonivirine
Placebo tablet matched to ulonivirine taken by mouth.
Interventions
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Islatravir
ISL capsule taken by mouth.
Ulonivirine
Ulonivirine tablet taken by mouth.
BIC/FTC/TAF
BIC/FTC/TAF tablet taken by mouth.
Placebo to ISL
Placebo capsule matched to ISL taken by mouth.
Placebo to Ulonivirine
Placebo tablet matched to ulonivirine taken by mouth.
Placebo to BIC/FTC/TAF
Placebo tablet matched to BIC/FTC/TAF taken by mouth.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has been virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) for ≥6 months
* Has a screening CD4+ T-cell count \>200 cells/mm\^3 (completed by the central laboratory)
* Is male or female, at least 18 years of age, at the time of signing the informed consent
* Female participants are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies:
* Is not a woman of childbearing potential (WOCBP)
* Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis)
Exclusion Criteria
* Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
* Has active hepatitis C virus (HCV) coinfection (defined as detectable HCV RNA) or hepatitis B virus (HBV) coinfection (defined as hepatitis B surface antigen \[HBsAg\]-positive or HBV deoxyribonucleic acid \[DNA\] positive)
* Has a current (active) diagnosis of acute hepatitis due to any cause
* Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
* Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study
* Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies
* Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period
* Has a documented or known virological resistance to ulonivirine or nucleoside/nucleotide reverse transcriptase inhibitors (NNRTI)
* Is female and expecting to conceive or donate eggs at any time during the study
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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Pueblo Family Physicians ( Site 2702)
Phoenix, Arizona, United States
Men's Health Foundation ( Site 2710)
Los Angeles, California, United States
Midway Immunology and Research ( Site 2713)
Ft. Pierce, Florida, United States
Triple O Research Institute, P.A. ( Site 2712)
West Palm Beach, Florida, United States
Infectious Disease Specialists Of Atlanta PC ( Site 2704)
Decatur, Georgia, United States
Chatham County Health Department ( Site 2707)
Savannah, Georgia, United States
Kansas City CARE Clinic ( Site 2703)
Kansas City, Missouri, United States
Saint Hope Foundation, Inc. ( Site 2716)
Bellaire, Texas, United States
Texas Centers for Infectious Disease Associates P.A. ( Site 2709)
Fort Worth, Texas, United States
DCOL Center for Clinical Research ( Site 2715)
Longview, Texas, United States
CHU de Toulouse - Hopital Purpan ( Site 2302)
Toulouse, Haute-Garonne, France
Hopital Gui de Chauliac. ( Site 2303)
Montpellier, Herault, France
CHU Hotel Dieu Nantes ( Site 2310)
Nantes, Loire-Atlantique, France
Centre Hospitalier Regional du Orleans ( Site 2304)
Orléans, Loiret, France
Hopital Avicenne ( Site 2305)
Bobigny, Seine-Saint-Denis, France
Hopital Saint Louis ( Site 2308)
Paris, , France
Hopital Saint-Antoine ( Site 2307)
Paris, , France
Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 2306)
Paris, Île-de-France Region, France
Universitaetsspital Zuerich ( Site 2601)
Zuerich, Canton of Aargau, Switzerland
Universitaetsspital Basel ( Site 2602)
Basel, Canton of Basel-City, Switzerland
Inselspital Universitaetsspital Bern ( Site 2603)
Bern, Canton of Bern, Switzerland
Hopitaux Universitaires de Geneve HUG ( Site 2604)
Geneva, Canton of Geneva, Switzerland
CHUV (centre hospitalier universitaire vaudois) ( Site 2605)
Lausanne, Canton of Vaud, Switzerland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-8591-013
Identifier Type: OTHER
Identifier Source: secondary_id
2024-511041-19-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1302-9886
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-003071-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
8591-013
Identifier Type: -
Identifier Source: org_study_id
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