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)
Public ClinicalTrials.gov record NCT04233879. 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 the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir Once-Daily in HIV-1 Infected Treatment-Naïve Participants
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04233879
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 599 participants
Conditions and interventions
Conditions
Interventions
- DOR/ISL Drug
- BIC/FTC/TAF Drug
- Placebo to BIC/FTC/TAF Drug
- Placebo to 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 28, 2020 (Actual)
- Primary completion
- Nov 17, 2022 (Actual)
- Completion
- Jan 29, 2025 (Actual)
- Last update posted
- Jun 3, 2026
2020 – 2025
United States locations
- U.S. sites
- 17
- U.S. states
- 9
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham 1917 Research Clinic ( Site 5610) | Birmingham | Alabama | 35222 | — |
| Pueblo Family Physicians ( Site 5606) | Phoenix | Arizona | 85015 | — |
| Ruane Clinical Research Group, Inc. ( Site 5624) | Los Angeles | California | 90036 | — |
| Midway Immunology and Research ( Site 5622) | Ft. Pierce | Florida | 34982 | — |
| The Kinder Medical Group ( Site 5615) | Miami | Florida | 33133 | — |
| Floridian Clinical Research, LLC ( Site 5625) | Miami Lakes | Florida | 33016 | — |
| Orlando Immunology Center ( Site 5613) | Orlando | Florida | 32803 | — |
| CAN Community Health ( Site 5627) | Sarasota | Florida | 34237 | — |
| Triple O Research Institute, P.A. ( Site 5621) | West Palm Beach | Florida | 33407 | — |
| Columbus Regional Research Institute ( Site 5616) | Columbus | Georgia | 31904 | — |
| Infectious Disease Specialists Of Atlanta PC ( Site 5608) | Decatur | Georgia | 30033 | — |
| Hennepin Healthcare-Hennepin Healthcare-ID ( Site 5633) | Minneapolis | Minnesota | 55415 | — |
| Kansas City CARE Clinic ( Site 5607) | Kansas City | Missouri | 64111 | — |
| University of Pennsylvania ( Site 5630) | Philadelphia | Pennsylvania | 19104 | — |
| Saint Hope Foundation, Inc. ( Site 5629) | Bellaire | Texas | 77401 | — |
| North Texas ID Consultants, PA ( Site 5604) | Dallas | Texas | 75246 | — |
| Texas Centers for Infectious Disease Associates P.A. ( Site 5619) | Fort Worth | Texas | 76104 | — |
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 78 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04233879, 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 Jun 3, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04233879 live on ClinicalTrials.gov.