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Oral Islatravir (MK-8591) Once-Monthly as Preexposure Prophylaxis (PrEP) in Men and Transgender Women Who Are at High Risk for HIV-1 Infection (MK-8591-024)

NCT04652700 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2026-05-05

Study results available
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Summary

The main purpose of the study is to evaluate the safety and tolerability 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 48 or 96 weeks of treatment and a minimum follow-up of 42 days.

Conditions

  • HIV Preexposure Prophylaxis

Interventions

DRUG

ISL

ISL 60 mg tablet, QM, orally for up to 24 months

DRUG

FTC/TDF

Participants receive 200/245 mg of FTC/TDF combination tablet, QD, orally for up to 24 months

DRUG

FTC/TAF

Participants receive 200/25 mg of FTC/TAF combination tablet, QD, orally for up to 24 months

DRUG

Placebo to ISL

Placebo ISL 0 mg tablets QM, orally for up to 24 months.

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-15
Primary Completion
2023-08-04
Completion
2023-08-04
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • France
  • Japan
  • Peru
  • South Africa
  • Thailand

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04652700 on ClinicalTrials.gov