Impower 022
Status:Stopped Early
Phase:III
Principal Investigator(s):
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 informationThis 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, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionExperimental: 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 DeliveryTablet
ARMsExperimental
DescriptionActive 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 DeliveryTablet
ARMs
Official Code:
NCT04644029
Trial Sponsors:
Merck Sharp & Dohme Corp.
Start Date
End Date
February 24, 2021
July 5, 2024
Enrollment:4,500
Age range:
16 Years ↔
45 Years
Population:Cisgender Women