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Status
Stopped Early
Phase
III
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 whether oral Islatravir (ISL) is effective in preventing Human Immunodeficiency Virus Type 1 (HIV-1) infection in women at high-risk for HIV-1 infection. The study will compare oral ISL taken once a month with standard-of-care medication for prevention of HIV-1 infection, emtricitabine/tenovir disproxil fumarate (FTC/TDF), taken once per day. The primary hypothesis is that oral ISL is more effective than FTC/TDF at reducing the incidence rate per year of confirmed HIV-1 infections.
Last updated September 20, 2022
Prevention Option(s)
PrEP
Study Design
Controlled
Randomized
Double-blind
Arms and Assigned Interventions
Description
Experimental: ISL QM
ISL (islatravir) once monthly AND placebo to FTC/TDF (emtricitabine/tenofovir disoproxil fumarate) once daily
Drug: ISL
Oral 60mg tablet administered once monthly
Other Name: MK-8591
Drug: Placebo to FTC/TDF
0mg tablet administered once daily
Mode of Delivery
Tablet
Products
Islatravir (MK-8591)
ARMs
Experimental
Description
Active Comparator: FTC/TDF QD
FTC/TDF (emtricitabine/tenofovir disoproxil fumarate) once daily AND placebo to ISL (islatravir) once monthly
Drug: FTC/TDF
200/245mg or 200/300mg tablet administered orally once daily
Other Names:
TRUVADA
Emtricitabine/Tenofovir disoproxil fumarate
Drug: Placebo to ISL
0mg tablet administered orally once monthly
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
Official Code
Related Publications
Similar Trials
Trial Sponsors
Merck Sharp & Dohme Corp.
February 2021
July 2024
Enrollment
4 500
16
Years
45
Years
Population
Women
Sites
University of Miami
Miami, Florida
United States of America
Orlando Immunology Center HVTN CRS
Orlando, Florida
United States of America
The University of Mississippi Medical Center
Jackson, Mississippi
United States of America
Prism Health North Texas, Oak Cliff Health Center
Dallas, Texas
United States of America
KC CARE Health Center-Clinical Trials
Kansas City, Missouri
United States of America
Rutgers Medical School CRC
Newark, New Jersey
United States of America
MedStar Health Research Institute
District of Columbia
United States of America
University of Alabama at Birmingham
Birmingham, Alabama
United States of America
Ponce de Leon
Atlanta, Georgia
United States of America
Bronx Prevention Center
Bronx, New York
United States of America
Chapel Hill CRS
Chapel Hill, North Carolina
United States of America
Themba Lethu Clinic, Helen Joseph Hospital
Johannesburg, Guateng
South Africa
Wits HIV CRS
Johannesburg, Gauteng
South Africa
Chatsworth CRS
Chatsworth, KwaZulu-Natal
South Africa
Madibeng Centre for Research
Brits
South Africa
Qhakaza Mbokodo Research Clinic
Ladysmith
South Africa