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NCT04233879 · ClinicalTrials.gov registry record · Phase 3
Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)
A Phase 3 study of HIV-1-infection, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 599
- Enrollment target
- 20
- Study locations
NCT04233879: Completed Phase 3 study of HIV-1-infection, sponsored by Merck Sharp & Dohme.
NCT04233879 is a Phase 3 study of HIV-1-infection that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 599 participants, above the 343-participant average among 71 other HIV-1-infection trials with a reported enrollment target (75% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04233879, a Phase 3 study of HIV-1-infection, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 599 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL \[also known as MK-8591A\]) in treatment-naïve participants living with human immunodeficiency virus type-1 (HIV-1) infection. The primary objectives are to evaluate the antiretroviral activity, safety, and tolerability of DOR/ISL compared to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that DOR/ISL is noninferior or superior to BIC/FTC/TAF treatment based on the percentage of participants with HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 48.
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. The percentage of participants with HIV-1 RNA \<50 copies/mL at Week 48 was presented using the Food and Drug Administration (FDA) Snapshot missing data approach. The final analysis for this outcome is presented here.
Conditions Studied
Interventions
- DRUG BIC/FTC/TAF
- DRUG DOR/ISL
- DRUG Placebo to BIC/FTC/TAF
- DRUG Placebo to DOR/ISL
Study Locations (20)
Florida
- Midway Immunology and Research ( Site 5622) - Ft. Pierce
- The Kinder Medical Group ( Site 5615) - Miami
- Floridian Clinical Research, LLC ( Site 5625) - Miami Lakes
- Orlando Immunology Center ( Site 5613) - Orlando
- CAN Community Health ( Site 5627) - Sarasota
- Triple O Research Institute, P.A. ( Site 5621) - West Palm Beach
Texas
- Saint Hope Foundation, Inc. ( Site 5629) - Bellaire
- North Texas ID Consultants, PA ( Site 5604) - Dallas
- Texas Centers for Infectious Disease Associates P.A. ( Site 5619) - Fort Worth
Buenos Aires F.D.
- Helios Salud S.A. ( Site 5802) - Buenos Aires
- IDEAA Foundation ( Site 5807) - Buenos Aires
- Fundación Huesped ( Site 5801) - C.a.b.a
Georgia
- Columbus Regional Research Institute ( Site 5616) - Columbus
- Infectious Disease Specialists Of Atlanta PC ( Site 5608) - Decatur
Alabama
- University of Alabama at Birmingham 1917 Research Clinic ( Site 5610) - Birmingham
Arizona
- Pueblo Family Physicians ( Site 5606) - Phoenix
California
- Ruane Clinical Research Group, Inc. ( Site 5624) - Los Angeles
Minnesota
- Hennepin Healthcare-Hennepin Healthcare-ID ( Site 5633) - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 599 participants |
| Start Date | 2020-02-28 |
| Est. Completion | 2025-01-29 |
| Phase | Phase 3 |
What the finished NCT04233879 record still lists
NCT04233879 is an interventional study that assigns participants to a tested intervention. The registered 599 participants enrollment target is mid-sized for trials with a published cap, above the 343-participant average among 71 other HIV-1-infection trials with a reported enrollment target (75% higher).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 4 interventions - of which BIC/FTC/TAF is the first listed.
NCT04233879 names 20 study sites across 10 states, led by Florida, Texas, Buenos Aires F.D..
Frequently Asked Questions
What is clinical trial NCT04233879 about?
NCT04233879 is a clinical study titled "Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)". This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL \[also known as MK-8591A\]) in treatment-naïve participants living with human immunodeficiency virus type-1 (HIV-1) infectio...
What is the current status of trial NCT04233879?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 599 participants. The study started on 2020-02-28. Estimated completion is 2025-01-29.
What conditions does trial NCT04233879 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT04233879?
The interventions under investigation include: BIC/FTC/TAF (DRUG), DOR/ISL (DRUG), Placebo to BIC/FTC/TAF (DRUG), Placebo to DOR/ISL (DRUG).
Who is sponsoring clinical trial NCT04233879?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04233879 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV-1-infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04233879's enrollment target sits among peer trials
599 10th of 71 higher than 62 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection 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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A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051)
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