DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)
Public ClinicalTrials.gov record NCT05705349. 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 (DOR/ISL 100 mg/0.25 mg) 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 randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL \[MK-8591A\]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 48.
Study identification
- NCT ID
- NCT05705349
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 537 participants
Conditions and interventions
Conditions
Interventions
- DOR/ISL Drug
- BIC/FTC/TAF Drug
- Placebo to DOR/ISL Drug
- Placebo to BIC/FTC/TAF Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 8, 2023 (Actual)
- Primary completion
- Oct 13, 2025 (Actual)
- Completion
- Aug 5, 2029 (Estimated)
- Last update posted
- Oct 5, 2026
2023 – 2029
United States locations
- U.S. sites
- 38
- U.S. states
- 15
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pueblo Family Physicians ( Site 5674) | Phoenix | Arizona | 85015 | — |
| Pacific Oaks Medical Group ( Site 5681) | Beverly Hills | California | 90211 | — |
| Ruane Clinical Research Group, Inc ( Site 5658) | Los Angeles | California | 90036 | — |
| Vivent Health ( Site 5694) | Denver | Colorado | 80246 | — |
| Washington Health Institute ( Site 5689) | Washington D.C. | District of Columbia | 20017 | — |
| Midway Immunology and Research Center ( Site 5657) | Ft. Pierce | Florida | 34982 | — |
| AHF The Kinder Medical Group ( Site 5672) | Miami | Florida | 33133 | — |
| AHF South Beach ( Site 5663) | Miami Beach | Florida | 33140 | — |
| Orlando Immunology Center ( Site 5654) | Orlando | Florida | 32803 | — |
| CAN Community Health - Sarasota ( Site 5668) | Sarasota | Florida | 34237 | — |
| Triple O Research Institute, P.A ( Site 5666) | West Palm Beach | Florida | 33407 | — |
| Emory University and Grady Health System-Medicine ( Site 5690) | Atlanta | Georgia | 30308 | — |
| Emory University Hospital Midtown Infectious Disease Clinic ( Site 5673) | Atlanta | Georgia | 30308 | — |
| Atlanta I.D. Group ( Site 5680) | Atlanta | Georgia | 30309 | — |
| Metro Infectious Diseases Consultants L.L.C. ( Site 5653) | Decatur | Georgia | 30033 | — |
| Mercer University, Department of Internal Medicine ( Site 5655) | Macon | Georgia | 31201 | — |
| Rush University Medical Center-Infectious Disease ( Site 5671) | Chicago | Illinois | 60612 | — |
| University of Illinois at Chicago-Project WISH ( Site 5685) | Chicago | Illinois | 60612 | — |
| Howard Brown Health Center-Clinical Research ( Site 5665) | Chicago | Illinois | 60613 | — |
| Be Well Medical Center ( Site 5650) | Berkley | Michigan | 48072 | — |
| Henry Ford Hospital ( Site 5667) | Detroit | Michigan | 48202 | — |
| KC CARE Health Center-Clinical Trials ( Site 5670) | Kansas City | Missouri | 64111 | — |
| Jubilee Clinical Research ( Site 5679) | Las Vegas | Nevada | 89106 | — |
| Las Vegas Research Center ( Site 5691) | Las Vegas | Nevada | 89106 | — |
| ID Care ( Site 5676) | Hillsborough | New Jersey | 08844 | — |
| Saint Michael's Medical Center ( Site 5682) | Newark | New Jersey | 07102 | — |
| Columbia University Irving Medical Center-Division of Infectious Diseases ( Site 5688) | New York | New York | 10032 | — |
| Jacobi Medical Center ( Site 5683) | The Bronx | New York | 10461 | — |
| Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 5675) | Charlotte | North Carolina | 28204 | — |
| Regional Center for Infectious Diseases ( Site 5687) | Greensboro | North Carolina | 27401 | — |
| University of Cincinnati Medical Center-Infectious Diseases - Outpatient ( Site 5662) | Cincinnati | Ohio | 45267-0405 | — |
| Central Texas Clinical Research ( Site 5661) | Austin | Texas | 78705 | — |
| St Hope Foundation ( Site 5659) | Bellaire | Texas | 77401 | — |
| Prism Health North Texas, Oak Cliff Health Center ( Site 5660) | Dallas | Texas | 75208 | — |
| North Texas Infectious Diseases Consultants, P.A ( Site 5651) | Dallas | Texas | 75246 | — |
| AXCES Research - Texas - El Paso ( Site 5692) | El Paso | Texas | 79902 | — |
| Texas Centers for Infectious Disease Associates ( Site 5656) | Fort Worth | Texas | 76104 | — |
| DCOL Center for Clinical Research ( Site 5664) | Longview | Texas | 75605 | — |
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 93 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05705349, 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 Oct 5, 2026 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05705349 live on ClinicalTrials.gov.