A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)
Public ClinicalTrials.gov record NCT05630755. 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 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objectives of this study are to evaluate the antiretroviral activity of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) at Week 48; and to evaluate the safety and tolerability of a switch to DOR/ISL compared with continued BIC/FTC/TAF, through Week 48. The primary hypotheses are that (1) DOR/ISL is non-inferior to continued BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48, with a margin of 4 percentage points used to define non-inferiority; and (2) DOR/ISL is superior to BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48.
Study identification
- NCT ID
- NCT05630755
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 514 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 17, 2023 (Actual)
- Primary completion
- Oct 25, 2024 (Actual)
- Completion
- Aug 4, 2028 (Estimated)
- Last update posted
- Nov 18, 2025
2023 – 2028
United States locations
- U.S. sites
- 24
- U.S. states
- 11
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pueblo Family Physicians ( Site 1425) | Phoenix | Arizona | 85015 | — |
| Pacific Oaks Medical Group ( Site 1400) | Beverly Hills | California | 90211 | — |
| Ruane Clinical Research Group, Inc ( Site 1414) | Los Angeles | California | 90036 | — |
| Mills Clinical Research ( Site 1433) | Los Angeles | California | 90069 | — |
| Whitman-Walker Institute ( Site 1431) | Washington D.C. | District of Columbia | 20005 | — |
| Therafirst Medical Center ( Site 1402) | Fort Lauderdale | Florida | 33308 | — |
| Midway Immunology and Research Center ( Site 1401) | Ft. Pierce | Florida | 34982 | — |
| AHF The Kinder Medical Group ( Site 1426) | Miami | Florida | 33133 | — |
| Orlando Immunology Center ( Site 1407) | Orlando | Florida | 32803 | — |
| Triple O Research Institute, P.A ( Site 1417) | West Palm Beach | Florida | 33407 | — |
| Infectious Disease Specialists of Atlanta ( Site 1403) | Decatur | Georgia | 30033 | — |
| Mercer University, Department of Internal Medicine ( Site 1411) | Macon | Georgia | 31201 | — |
| AccessHealth MA ( Site 1419) | Boston | Massachusetts | 02129 | — |
| Be Well Medical Center ( Site 1408) | Berkley | Michigan | 48072 | — |
| KC CARE Health Center-Clinical Trials ( Site 1422) | Kansas City | Missouri | 64111 | — |
| Las Vegas Research Center ( Site 1436) | Las Vegas | Nevada | 89106 | — |
| Regional Center for Infectious Disease Research ( Site 1435) | Greensboro | North Carolina | 27401 | — |
| Central Texas Clinical Research ( Site 1413) | Austin | Texas | 78705 | — |
| St Hope Foundation ( Site 1410) | Bellaire | Texas | 77401 | — |
| Prism Health North Texas, Oak Cliff Health Center ( Site 1409) | Dallas | Texas | 75205 | — |
| North Texas Infectious Diseases Consultants, P.A ( Site 1404) | Dallas | Texas | 75246 | — |
| Texas Centers for Infectious Disease Associates ( Site 1406) | Fort Worth | Texas | 76104 | — |
| The Crofoot Research Center ( Site 1424) | Houston | Texas | 77098 | — |
| DCOL Center for Clinical Research ( Site 1415) | 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 25 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05630755, 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 Nov 18, 2025 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05630755 live on ClinicalTrials.gov.