A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051)
Public ClinicalTrials.gov record NCT05631093. 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 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Antiretroviral Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objectives of this study are to evaluate the safety and tolerability of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued baseline antiretroviral therapy (ART), through Week 48; and to evaluate the antiretroviral activity of a switch to DOR/ISL compared with continued baseline ART at Week 48. The primary hypothesis is that DOR/ISL is non-inferior to continued baseline ART, 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.
Study identification
- NCT ID
- NCT05631093
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 553 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 20, 2023 (Actual)
- Primary completion
- Oct 10, 2024 (Actual)
- Completion
- Jul 11, 2028 (Estimated)
- Last update posted
- Nov 21, 2025
2023 – 2028
United States locations
- U.S. sites
- 15
- U.S. states
- 7
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kaiser Permanente-Infectious Disease ( Site 3014) | Los Angeles | California | 90027 | — |
| Palmtree Clinical Research ( Site 3032) | Palm Springs | California | 92262 | — |
| Zuckerberg San Francisco General Hospital and Trauma Center-UCSF ID Clinical Trials Center ( Site 30 | San Francisco | California | 94110 | — |
| Georgetown University Medical Center ( Site 3006) | Washington D.C. | District of Columbia | 20007 | — |
| Midway Immunology and Research Center ( Site 3009) | Ft. Pierce | Florida | 34982 | — |
| Orlando Immunology Center ( Site 3004) | Orlando | Florida | 32803 | — |
| CAN Community Health - Sarasota ( Site 3017) | Sarasota | Florida | 34237 | — |
| Triple O Research Institute, P.A ( Site 3026) | West Palm Beach | Florida | 33407 | — |
| Infectious Disease Specialists of Atlanta ( Site 3003) | Decatur | Georgia | 30033 | — |
| Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3028) | Savannah | Georgia | 31401 | — |
| ID Care ( Site 3041) | Hillsborough | New Jersey | 08844 | — |
| Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site | Philadelphia | Pennsylvania | 19104 | — |
| Central Texas Clinical Research ( Site 3015) | Austin | Texas | 78705 | — |
| The Crofoot Research Center ( Site 3040) | Houston | Texas | 77098 | — |
| DCOL Center for Clinical Research ( Site 3022) | 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 38 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05631093, 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 21, 2025 · 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 NCT05631093 live on ClinicalTrials.gov.