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NCT04223791 · ClinicalTrials.gov registry record · Phase 3
Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)
A Phase 3 study of HIV Infection, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 643
- Enrollment target
- 20
- Study locations
NCT04223791: Completed Phase 3 study of HIV Infection, sponsored by Merck Sharp & Dohme.
NCT04223791 is a Phase 3 study of HIV Infection that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 643 participants, above the 234-participant average among 73 other HIV Infection trials with a reported enrollment target (175% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04223791, a Phase 3 study of HIV Infection, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 643 participants
- Enrollment target
- 20
- Study locations
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 regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with BIC/FTC/TAF as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48. Participants who benefit from their assigned intervention (as determined by investigator) will be able to continue treatment through a 24-week study extension.
Primary Outcome
The Abbott RealTime polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. Per protocol, the primary outcome measure, the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48, is presented using the Food and Drug Administration (FDA) Snapshot missing data approach. The percentage values were rounded to the nearest tenth digit.
Conditions Studied
Interventions
- DRUG BIC/FTC/TAF
- DRUG DOR/ISL
- DRUG Placebo to BIC/FTC/TAF
- DRUG Placebo to FDC DOR/ISL
Study Locations (20)
California
- Pacific Oaks Medical Group ( Site 2765) - Beverly Hills
- Men's Health Foundation ( Site 2749) - Los Angeles
- Kaiser Permanente Los Angeles Medical Center ( Site 2775) - Los Angeles
- Eisenhower Medical Center ( Site 2744) - Palm Springs
- University of California, Davis, Division of ID Research ( Site 2702) - Sacramento
- Zuckerberg San Francisco General Hospital UCSF ( Site 2743) - San Francisco
Florida
- TheraFirst Medical Center ( Site 2742) - Fort Lauderdale
- Midway Immunology and Research ( Site 2759) - Ft. Pierce
- The Kinder Medical Group ( Site 2739) - Miami
- AHF South Beach ( Site 2780) - Miami Beach
- Orlando Immunology Center ( Site 2734) - Orlando
- Triple O Research Institute, P.A. ( Site 2755) - West Palm Beach
Georgia
- Augusta University ( Site 2752) - Augusta
- Infectious Disease Specialists Of Atlanta PC ( Site 2719) - Decatur
- Mercer University ( Site 2738) - Macon
- Chatham County Health Department ( Site 2731) - Savannah
Arizona
- Pueblo Family Physicians ( Site 2717) - Phoenix
District of Columbia
- Whitman-Walker Clinic ( Site 2728) - Washington D.C.
Minnesota
- Hennepin County Medical Center ( Site 2733) - Minneapolis
Missouri
- Kansas City CARE Clinic ( Site 2718) - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 643 participants |
| Start Date | 2020-02-18 |
| Est. Completion | 2025-02-27 |
| Phase | Phase 3 |
What the finished NCT04223791 record still lists
NCT04223791 is an interventional study that assigns participants to a tested intervention. The registered 643 participants enrollment target is mid-sized for trials with a published cap, above the 234-participant average among 73 other HIV Infection trials with a reported enrollment target (175% higher).
The record links to 1 condition, with HIV Infection appearing as the primary indexed condition, and to 4 interventions - of which BIC/FTC/TAF is the first listed.
NCT04223791 names 20 study sites across 7 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT04223791 about?
NCT04223791 is a clinical study titled "Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)". 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 regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Th...
What is the current status of trial NCT04223791?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 643 participants. The study started on 2020-02-18. Estimated completion is 2025-02-27.
What conditions does trial NCT04223791 study?
This clinical trial studies the following conditions: HIV Infection.
What interventions are being tested in trial NCT04223791?
The interventions under investigation include: BIC/FTC/TAF (DRUG), DOR/ISL (DRUG), Placebo to BIC/FTC/TAF (DRUG), Placebo to FDC DOR/ISL (DRUG).
Who is sponsoring clinical trial NCT04223791?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04223791 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04223791's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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