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Impower 022

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)
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Trial Sponsors
Merck Sharp & Dohme Corp.
February 2021
July 2024
Enrollment
4 500
16
Years
45
Years
Population
Women
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