MK-8591-016
Status:Stopped Early
Phase:II
Principal Investigator(s):
Objective:Monthly oral islatravir development for pre-exposure prophylaxis is discontinued as of September 2022. In December 2021 related islatravir studies showed lower lymphocyte and CD4+ T cell counts in some participants. See Merck’s press release for more informationThis 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.Last updated September 20, 2022
Prevention Option(s):PrEP
Study Design:Randomized
Arms and Assigned Interventions
Description60 mg islatravir + placebo for islatravir administered once monthly, orally in capsule form for 24 weeks
Mode of DeliveryTablet
ARMsExperimental
Description120 mg islatravir administered once monthly, orally in capsule form for 24 weeks
Mode of DeliveryTablet
ARMsExperimental
Official Code:
Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Viru (https://clinicaltrials.gov/ct2/show/NCT04003103)
Start Date
End Date
September 13, 2019
March 3, 2022
Enrollment:250
Age range:
18 Years ↔
65
Population:Cisgender Men