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)

Completed · Phase 2 · Has a placebo group

Conditions studied: HIV-1 Infection

In brief

This study will evaluate the safety, tolerability and pharmacokinetics (PK) of 6 once-monthly doses of oral islatravir (60 mg and 120 mg) compared with placebo in adults at low risk of HIV-1 infection

Key facts

Study ID

NCT04003103

Run by

Merck Sharp & Dohme LLC

People needed

242

Starts

2019-09-19

Expected to finish

2022-11-24

Last updated by the study team

2025-07-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Is in general good health with acceptable laboratory values at screening
• 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.

You may not qualify if…

• Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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