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MK-8591-016

Status
Stopped Early
Phase
II
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 information

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.

Last updated September 20, 2022

Prevention Option(s)
PrEP
Study Design
Randomized
Arms and Assigned Interventions
Description
60 mg islatravir + placebo for islatravir administered once monthly, orally in capsule form for 24 weeks
Mode of Delivery
Tablet
Products
Islatravir (MK-8591)
ARMs
Experimental
Description
120 mg islatravir administered once monthly, orally in capsule form for 24 weeks
Mode of Delivery
Tablet
Products
Islatravir (MK-8591)
ARMs
Experimental
Description
Placebo for islatravir administered once monthly, orally in capsule form for 24 weeks
ARMs
Placebo Comparator
Official Code
Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Viru
September 2019
March 2022
Enrollment
250
18
Years
65
Population
Men
Sites

Research Centers of America, LLC

Florida
United States of America

Celerion, Inc.

Lincoln
United States of America

Magee Women's Hospital of UPMC

Pittsburgh
United States of America

College of Medicine John Hopkins University Clinical Research Site

Blantyre
Malawi

Josha Research Center

Josha, Bloemfontein
South Africa

Hadassah Ein Karem Jerusalem

Jerusalem
Israel

Rambam Medical Center

Haifa
Israel

Emavundleni Vaccine Centre

Cape Town
South Africa

Clinical HIV Research Unit CHRU

Johannesburg
South Africa