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NCT04652700 · ClinicalTrials.gov registry record · Phase 3

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)

A Phase 3 study, sponsored by Merck Sharp & Dohme.

Terminated
Registry status
Phase 3
Development phase
494
Enrollment target

NCT04652700 is a Phase 3 study that was terminated before completion, run by Merck Sharp & Dohme. The registered enrollment target is 494 participants.

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The verdict

NCT04652700, a Phase 3 study, was terminated before completion, sponsored by Merck Sharp & Dohme.

TERMINATED
Registry status
Phase 3
Development phase
494 participants
Enrollment target

Study 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.

Interventions

  • DRUG FTC/TDF
  • DRUG Placebo to FTC/TDF
  • DRUG ISL
  • DRUG FTC/TAF
  • DRUG Placebo to ISL

Trial Details

FieldValue
Enrollment Target 494 participants
Start Date 2021-03-15
Est. Completion 2023-08-04
Phase Phase 3

Sponsor

Merck Sharp & Dohme

558 total trials

What the Registry Record Tells You About NCT04652700

The ClinicalTrials.gov registry entry for NCT04652700 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 494 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which FTC/TDF is the first listed.

NCT04652700 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04652700 about?

NCT04652700 is a clinical study titled "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)". 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 ...

What is the current status of trial NCT04652700?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 494 participants. The study started on 2021-03-15. Estimated completion is 2023-08-04.

What interventions are being tested in trial NCT04652700?

The interventions under investigation include: FTC/TDF (DRUG), Placebo to FTC/TDF (DRUG), ISL (DRUG), FTC/TAF (DRUG), Placebo to ISL (DRUG).

Who is sponsoring clinical trial NCT04652700?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.