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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: Completed Phase 2 study, sponsored by Merck Sharp & Dohme.
NCT04564547 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 161 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
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. As pre-specified in the protocol and supplemental statistical analysis plan (sSAP), presented here is the percentage of participants who experienced one or more AEs during the Double-blind Treatment Period and includes the 42 days following the final dose of double-blind study intervention.
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 |
What the finished NCT04564547 record still lists
NCT04564547 is an interventional study that assigns participants to a tested intervention. The registered 161 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 (21% higher).
The record links to 0 conditions, and to 5 interventions - of which BIC/FTC/TAF is the first listed.
NCT04564547 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04564547's enrollment target sits among peer trials
161 422nd of 2000 higher than 1,579 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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