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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 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 672 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04223778
The ClinicalTrials.gov registry entry for NCT04223778 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 672 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 2 interventions - of which ART is the first listed.
NCT04223778 reports 0 study locations.
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.
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