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MK-8591-016

Status
Ongoing
Phase
II
Objective

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

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
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