Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)
Public ClinicalTrials.gov record NCT04223778. 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, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Antiretroviral Therapy
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 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.
Study identification
- NCT ID
- NCT04223778
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 672 participants
Conditions and interventions
Conditions
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
- Sep 8, 2021 (Actual)
- Completion
- Aug 26, 2024 (Actual)
- Last update posted
- Feb 18, 2026
2020 – 2024
United States locations
- U.S. sites
- 15
- U.S. states
- 9
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Georgetown University Hospital ( Site 1018) | Washington D.C. | District of Columbia | 20007 | — |
| Midway Immunology and Research ( Site 1030) | Ft. Pierce | Florida | 34982 | — |
| Orlando Immunology Center ( Site 1007) | Orlando | Florida | 32803 | — |
| Bliss Healthcare Services ( Site 1025) | Orlando | Florida | 32806 | — |
| Triple O Research Institute, P.A. ( Site 1026) | West Palm Beach | Florida | 33407 | — |
| Chatham County Health Department ( Site 1043) | Savannah | Georgia | 31401 | — |
| Northstar Healthcare ( Site 1002) | Chicago | Illinois | 60657 | — |
| Kansas City CARE Health Center ( Site 1008) | Kansas City | Missouri | 64111 | — |
| ID Care ( Site 1023) | Hillsborough | New Jersey | 08844 | — |
| University of North Carolina at Chapel Hill ( Site 1042) | Chapel Hill | North Carolina | 27599 | — |
| University of Pennsylvania ( Site 1038) | Philadelphia | Pennsylvania | 19104 | — |
| Saint Hope Foundation, Inc. ( Site 1037) | Bellaire | Texas | 77401 | — |
| North Texas ID Consultants, PA ( Site 1003) | Dallas | Texas | 75246 | — |
| Texas Centers for Infectious Disease Associates P.A. ( Site 1022) | Fort Worth | Texas | 76104 | — |
| The Crofoot Research Center, Inc. ( Site 1005) | Houston | Texas | 77098 | — |
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 63 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04223778, 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 Feb 18, 2026 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04223778 live on ClinicalTrials.gov.