Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT04003103 · ClinicalTrials.gov registry record · Phase 2

Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)

A Phase 2 study, sponsored by Merck Sharp & Dohme.

Completed
Registry status
Phase 2
Development phase
242
Enrollment target

NCT04003103 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 242 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04003103, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.

COMPLETED
Registry status
Phase 2
Development phase
242 participants
Enrollment target

Study Summary

This study will evaluate the safety, tolerability and pharmacokinetics (PK) of 6 once-monthly doses of oral islatravir (60 mg and 120 mg) compared with placebo in adults at low risk of HIV-1 infection

Interventions

  • DRUG Placebo
  • DRUG Islatravir

Trial Details

FieldValue
Enrollment Target 242 participants
Start Date 2019-09-19
Est. Completion 2022-11-24
Phase Phase 2

Sponsor

Merck Sharp & Dohme

558 total trials

What the Registry Record Tells You About NCT04003103

The ClinicalTrials.gov registry entry for NCT04003103 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 242 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 2 interventions - of which Placebo is the first listed.

NCT04003103 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04003103 about?

NCT04003103 is a clinical study titled "Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)". This study will evaluate the safety, tolerability and pharmacokinetics (PK) of 6 once-monthly doses of oral islatravir (60 mg and 120 mg) compared with placebo in adults at low risk of HIV-1 infection

What is the current status of trial NCT04003103?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 242 participants. The study started on 2019-09-19. Estimated completion is 2022-11-24.

What interventions are being tested in trial NCT04003103?

The interventions under investigation include: Placebo (DRUG), Islatravir (DRUG).

Who is sponsoring clinical trial NCT04003103?

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.