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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 494 participants |
| Start Date | 2021-03-15 |
| Est. Completion | 2023-08-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗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.
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