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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: Clinical Trial Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT04652700 is a Phase 3 study that was terminated before completion, run by Merck Sharp & Dohme. The registered enrollment target is 494 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
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. The number of participants who experienced an AE will be reported for each treatment arm.
Interventions
- DRUG FTC/TDF
- DRUG Placebo to FTC/TDF
- DRUG ISL
- DRUG FTC/TAF
- DRUG Placebo to ISL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 494 participants |
| Start Date | 2021-03-15 |
| Est. Completion | 2023-08-04 |
| Phase | Phase 3 |
Why NCT04652700 stopped before completion
NCT04652700 is an interventional study that assigns participants to a tested intervention. The registered 494 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 5 interventions - of which FTC/TDF is the first listed.
NCT04652700 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04652700's enrollment target sits among peer trials
494 779th of 2000 higher than 1,222 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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