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 informationThe 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 September 20, 2022
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionExperimental: 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 DeliveryTablet
DescriptionActive 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 DeliveryTablet
Official Code: NCT04652700
Trial Sponsors: Merck Sharp & Dohme Corp.
March 15, 2021
September 27, 2024
Age range: 16 Years ↔ any
Population:Cisgender Men, Gay and Bisexual Men Who Have Sex with Men, Transgender Women