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NCT04223778 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 672
- Enrollment target
NCT04223778: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT04223778 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 672 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04223778, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 672 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a protocol-specified antiretroviral regimen. The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with baseline antiretroviral therapy (ART) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48.
Primary Outcome
HIV-1 RNA levels in blood samples taken at each visit were measured by the Abbott RealTime polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
Interventions
- DRUG ART
- DRUG DOR/ISL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 672 participants |
| Start Date | 2020-02-18 |
| Est. Completion | 2024-08-26 |
| Phase | Phase 3 |
What the finished NCT04223778 record still lists
NCT04223778 is an interventional study that assigns participants to a tested intervention. The registered 672 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 (13% lower).
The record links to 0 conditions, and to 2 interventions - of which ART is the first listed.
NCT04223778 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04223778 about?
NCT04223778 is a clinical study titled "Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)". This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a protocol-specified antiretroviral regimen. The primary hypothesis is that a ...
What is the current status of trial NCT04223778?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 672 participants. The study started on 2020-02-18. Estimated completion is 2024-08-26.
What interventions are being tested in trial NCT04223778?
The interventions under investigation include: ART (DRUG), DOR/ISL (DRUG).
Who is sponsoring clinical trial NCT04223778?
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 NCT04223778's enrollment target sits among peer trials
672 544th of 2000 higher than 1,457 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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