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NCT04564547 · ClinicalTrials.gov registry record · Phase 2
Dose Ranging, Switch Study of Islatravir (MK-8591) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 161
- Enrollment target
NCT04564547 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 161 participants.
The verdict
NCT04564547, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 161 participants
- Enrollment target
Study Summary
This is a randomized, controlled, double-blind, study to evaluate the safety and tolerability of islatravir (ISL) + ulonivirine based on review of the accumulated safety data, in adult participants with human immunodeficiency virus type 1 (HIV-1) who have been virologically suppressed for ≥6 months on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) once-daily.
Interventions
- DRUG BIC/FTC/TAF
- DRUG Ulonivirine
- DRUG Islatravir
- DRUG Placebo to ISL
- DRUG Placebo to Ulonivirine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2021-03-09 |
| Est. Completion | 2025-01-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04564547
The ClinicalTrials.gov registry entry for NCT04564547 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 161 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 BIC/FTC/TAF is the first listed.
NCT04564547 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04564547 about?
NCT04564547 is a clinical study titled "Dose Ranging, Switch Study of Islatravir (MK-8591) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]". This is a randomized, controlled, double-blind, study to evaluate the safety and tolerability of islatravir (ISL) + ulonivirine based on review of the accumulated safety data, in adult participants with human immunodeficiency virus type 1 (HIV-1) who have been virologically suppressed for ≥6 months ...
What is the current status of trial NCT04564547?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 161 participants. The study started on 2021-03-09. Estimated completion is 2025-01-30.
What interventions are being tested in trial NCT04564547?
The interventions under investigation include: BIC/FTC/TAF (DRUG), Ulonivirine (DRUG), Islatravir (DRUG), Placebo to ISL (DRUG), Placebo to Ulonivirine (DRUG).
Who is sponsoring clinical trial NCT04564547?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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