Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)
NCT ID: NCT04003103
Last Updated: 2025-07-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
242 participants
INTERVENTIONAL
2019-09-19
2022-11-24
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
PREVENTION
DOUBLE
Study Groups
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Islatravir 60 mg
60 mg islatravir + placebo for islatravir administered once monthly, orally in capsule form for 24 weeks
Islatravir
Islatravir 30 mg capsules taken by mouth.
Placebo
Placebo capsules taken by mouth.
Islatravir 120 mg
120 mg islatravir administered once monthly, orally in capsule form for 24 weeks
Islatravir
Islatravir 30 mg capsules taken by mouth.
Placebo
Placebo for islatravir administered once monthly, orally in capsule form for 24 weeks
Placebo
Placebo capsules taken by mouth.
Interventions
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Islatravir
Islatravir 30 mg capsules taken by mouth.
Placebo
Placebo capsules taken by mouth.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization
* Has low risk of HIV infection, within 12 months prior to screening visit or the rescreening visit (if applicable)
* Use contraceptives consistent with local regulations
* Female is not pregnant or breastfeeding, and is not a woman of childbearing potential (WOCBP)
* A WOCBP is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle; or has a negative pregnancy test.
Exclusion Criteria
* Has an active diagnosis of 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 or in situ cervical cancer.
* Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies from 30 days prior to Day
1 through the duration of the study.
* Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 30 days prior to Day1 through the duration of the study.
* Has previously been randomized in a study and received islatravir (MK-8591).
* Female is expecting to conceive or donate eggs at any time during the study
* Has QTc interval (using Fridericia correction) \>450 msec (for males) or \>460 msec (for females) or deemed clinically abnormal by the investigator.
18 Years
65 Years
ALL
Yes
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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Research Centers of America, LLC ( Site 0007)
Hollywood, Florida, United States
Johns Hopkins School of Medicine - Drug Development Unit ( Site 0002)
Baltimore, Maryland, United States
Celerion, Inc. ( Site 0006)
Lincoln, Nebraska, United States
Magee Womens Research Institute ( Site 0001)
Pittsburgh, Pennsylvania, United States
Hadassah Ein Karem Jerusalem ( Site 0016)
Jerusalem, Jerusalem, Israel
Rambam Medical Center ( Site 0017)
Haifa, , Israel
JOSHA Research ( Site 0015)
Bloemfontein, Free State, South Africa
Clinical HIV Research Unit CHRU ( Site 0014)
Johannesburg, Gauteng, South Africa
Emavundleni Vaccine Centre ( Site 0011)
Cape Town, Western Cape, South Africa
Countries
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References
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Hillier SL, Bekker LG, Riddler SA, Hendrix CW, Badal-Faesen S, Macdonald P, Nair G, Lombaard J, Caraco Y, Peer A, Patel M, Vargo R, Homony B, Nedrow K, Evans B, Wickremasingha P, Zhou YP, Teal V, Hwang P, McMullan C, Kaufman KD, Robertson MN, Plank RM. Safety, Tolerability, and Pharmacokinetics of Once-Monthly Oral Islatravir: a Phase 2a Study in Participants at Low Risk for Acquiring HIV-1. J Infect Dis. 2025 May 6:jiaf222. doi: 10.1093/infdis/jiaf222. Online ahead of print.
Pham M, Wickremasingha P, Vargo R, Patel M, Nedrow K, Homony B, Robertson MN, Plank RM. Exploratory Substudy of a Phase 2 Trial to Evaluate the Pharmacokinetic Effect of Once-Monthly Islatravir on Long-Acting Reversible Contraceptives. J Acquir Immune Defic Syndr. 2025 Apr 22;99(4):374-8. doi: 10.1097/QAI.0000000000003678. Online ahead of print.
Devanathan AS, Cottrell ML. Pharmacology of HIV Cure: Site of Action. Clin Pharmacol Ther. 2021 Apr;109(4):841-855. doi: 10.1002/cpt.2187. Epub 2021 Mar 5.
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
Other Identifiers
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Merck Protocol Number
Identifier Type: OTHER
Identifier Source: secondary_id
2019-001704-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
8591-016
Identifier Type: -
Identifier Source: org_study_id
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