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)
Public ClinicalTrials.gov record NCT04223791. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the safety and efficacy of a switch to Doravirine/Islatravir (DOR/ISL) (MK-8591A) (a fixed dose combination of doravirine 100 mg and islatravir 0.75 mg) in participants living with human immunodeficiency virus-1 (HIV-1) virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to DOR/ISL (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.
Study identification
- NCT ID
- NCT04223791
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 643 participants
Conditions and interventions
Conditions
Interventions
- DOR/ISL Drug
- BIC/FTC/TAF Drug
- Placebo to BIC/FTC/TAF Drug
- Placebo to FDC DOR/ISL Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 18, 2020 (Actual)
- Primary completion
- Aug 26, 2021 (Actual)
- Completion
- Feb 27, 2025 (Actual)
- Last update posted
- Mar 27, 2026
2020 – 2025
United States locations
- U.S. sites
- 28
- U.S. states
- 11
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pueblo Family Physicians ( Site 2717) | Phoenix | Arizona | 85015 | — |
| Pacific Oaks Medical Group ( Site 2765) | Beverly Hills | California | 90211 | — |
| Men's Health Foundation ( Site 2749) | Los Angeles | California | 80069 | — |
| Kaiser Permanente Los Angeles Medical Center ( Site 2775) | Los Angeles | California | 90027 | — |
| Eisenhower Medical Center ( Site 2744) | Palm Springs | California | 92264 | — |
| University of California, Davis, Division of ID Research ( Site 2702) | Sacramento | California | 95811 | — |
| Zuckerberg San Francisco General Hospital UCSF ( Site 2743) | San Francisco | California | 94110 | — |
| Whitman-Walker Clinic ( Site 2728) | Washington D.C. | District of Columbia | 20009 | — |
| TheraFirst Medical Center ( Site 2742) | Fort Lauderdale | Florida | 33308 | — |
| Midway Immunology and Research ( Site 2759) | Ft. Pierce | Florida | 34982 | — |
| The Kinder Medical Group ( Site 2739) | Miami | Florida | 33133 | — |
| AHF South Beach ( Site 2780) | Miami Beach | Florida | 33140 | — |
| Orlando Immunology Center ( Site 2734) | Orlando | Florida | 32803 | — |
| Triple O Research Institute, P.A. ( Site 2755) | West Palm Beach | Florida | 33407 | — |
| Augusta University ( Site 2752) | Augusta | Georgia | 30912 | — |
| Infectious Disease Specialists Of Atlanta PC ( Site 2719) | Decatur | Georgia | 30033 | — |
| Mercer University ( Site 2738) | Macon | Georgia | 31201 | — |
| Chatham County Health Department ( Site 2731) | Savannah | Georgia | 31401 | — |
| Hennepin County Medical Center ( Site 2733) | Minneapolis | Minnesota | 55415 | — |
| Kansas City CARE Clinic ( Site 2718) | Kansas City | Missouri | 64111 | — |
| ID Care ( Site 2751) | Hillsborough | New Jersey | 08844 | — |
| Icahn School of Medicine at Mount Sinai ( Site 2700) | New York | New York | 10029 | — |
| Montefiore Einstein Center ( Site 2730) | The Bronx | New York | 10467 | — |
| North Texas ID Consultants, PA ( Site 2707) | Dallas | Texas | 75246 | — |
| The Crofoot Research Center, Inc. ( Site 2715) | Houston | Texas | 77098 | — |
| DCOL Center for Clinical Research ( Site 2769) | Longview | Texas | 75605 | — |
| Dr. Peter Shalit, MD ( Site 2770) | Seattle | Washington | 98104 | — |
| Multicare Health System ( Site 2713) | Spokane | Washington | 99204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 61 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04223791, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 27, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04223791 live on ClinicalTrials.gov.