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Impower-024

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

The main purpose of the study is to evaluate the efficacy and safety of oral Islatravir (ISL) once monthly (QM) as Preexposure Prophylaxis (PrEP) in cisgender men who have sex with men (MSM) and transgender women (TGW) who have sex with men and who are at high risk of HIV-1 infection with a minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up after randomization. The primary hypothesis of the study is that the administration of ISL QM as PreP reduces the incidence rate per year of the confirmed HIV-1 infections compared to the background incidence rates.


Last updated December 24, 2021

Prevention Option(s)
PrEP
Study Design
Controlled
Randomized
Double-blind
Arms and Assigned Interventions
Description
Experimental: Islatravir (ISL) Once Monthly (QM) Group Participants receive 60 mg tablet of ISL QM, orally plus Placebo to Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) tablet once daily (QD) or Placebo to Emtricitabine/Tenofovir Alafenamide (FTC/TAF) tablet QD, orally for up to 24 months of treatment duration. Drug: ISL ISL 60 mg tablet, QM, orally for up to 24 months Other Name: MK-8591 Drug: Placebo to FTC/TDF Placebo FTC/TDF 0 mg tablets QD, orally for up to 24 months Drug: Placebo to FTC/TAF Placebo FTC/TAF 0 mg tablets QD, orally for up to 24 months
Mode of Delivery
Tablet
Products
Islatravir (MK-8591)
ARMs
Experimental
Description
Active Comparator: FTC/TDF or FTC/TAF QD Group Participants receive 200/245 mg or 200/300 mg of FTC/TDF combination tablet, QD, orally or 200/25 mg of FTC/TAF combination tablet, QD, orally at investigator's discretion plus Placebo to ISL tablet QM, orally for up to 24 months of treatment duration. Drug: FTC/TDF Participants receive 200/245 mg or 200/300 mg of FTC/TDF combination tablet, QD, orally for up to 24 months Other Names: Truvada Emtricitabine/Tenofovir Disoproxil Fumarate Drug: FTC/TAF Participants receive 200/25 mg of FTC/TAF combination tablet, QD, orally for up to 24 months Other Names: Descovy Emtricitabine/Tenofovir Alafenamide Drug: Placebo to ISL Placebo ISL 0 mg tablets QM, orally for up to 24 months.
Mode of Delivery
Tablet
Products
Islatravir (MK-8591)
Trial Sponsors
Merck Sharp & Dohme Corp.
March 2021
September 2024
Enrollment
1 500
16
Years
Population
Men
MSM
Transgender women