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Impower 022

Status
Paused
Phase
III
Objective

On hold. Related islatravir studies showed lower lymphocyte and CD4+ T cell counts in some participants. See Merck’s press release for more information on this paused trial.

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 December 24, 2021

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)
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