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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: Completed Phase 2 study, sponsored by Merck Sharp & Dohme.
NCT04003103 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 242 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% higher). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Interventions
- DRUG Placebo
- DRUG Islatravir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2019-09-19 |
| Est. Completion | 2022-11-24 |
| Phase | Phase 2 |
What the finished NCT04003103 record still lists
NCT04003103 is an interventional study that assigns participants to a tested intervention. The registered 242 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04003103 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04003103's enrollment target sits among peer trials
242 237th of 2000 higher than 1,762 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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