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NCT05631093 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of HIV-1-infection, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 553
- Enrollment target
- 20
- Study locations
NCT05631093: Active Phase 3 study of HIV-1-infection, sponsored by Merck Sharp & Dohme.
NCT05631093 is a Phase 3 study of HIV-1-infection that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 553 participants, above the 344-participant average among 71 other HIV-1-infection trials with a reported enrollment target (61% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05631093, a Phase 3 study of HIV-1-infection, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 553 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
HIV-1 RNA levels in plasma were measured by polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of \<50 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
Conditions Studied
Interventions
- DRUG ART
- DRUG DOR/ISL
Study Locations (20)
Florida
- Midway Immunology and Research Center ( Site 3009) - Ft. Pierce
- Orlando Immunology Center ( Site 3004) - Orlando
- CAN Community Health - Sarasota ( Site 3017) - Sarasota
- Triple O Research Institute, P.A ( Site 3026) - West Palm Beach
California
- Kaiser Permanente-Infectious Disease ( Site 3014) - Los Angeles
- Palmtree Clinical Research ( Site 3032) - Palm Springs
- Zuckerberg San Francisco General Hospital and Trauma Center-UCSF ID Clinical Trials Center ( Site 30 - San Francisco
Texas
- Central Texas Clinical Research ( Site 3015) - Austin
- The Crofoot Research Center ( Site 3040) - Houston
- DCOL Center for Clinical Research ( Site 3022) - Longview
Georgia
- Infectious Disease Specialists of Atlanta ( Site 3003) - Decatur
- Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3028) - Savannah
New South Wales
- Holdsworth House Medical Practice ( Site 4200) - Darlinghurst
- St Vincent's Hospital-IBAC ( Site 4203) - Sydney
Queensland
- Holdsworth House Medical Practice - Brisbane ( Site 4201) - Brisbane
- Royal Brisbane and Women's Hospital-Infectious Diseases Research ( Site 4204) - Brisbane
District of Columbia
- Georgetown University Medical Center ( Site 3006) - Washington D.C.
New Jersey
- ID Care ( Site 3041) - Hillsborough
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 553 participants |
| Start Date | 2023-02-20 |
| Est. Completion | 2028-07-11 |
| Phase | Phase 3 |
What the registry record for NCT05631093 still lists
NCT05631093 is an interventional study that assigns participants to a tested intervention. The registered 553 participants enrollment target is mid-sized for trials with a published cap, above the 344-participant average among 71 other HIV-1-infection trials with a reported enrollment target (61% higher).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 2 interventions - of which ART is the first listed.
NCT05631093 names 20 study sites across 10 states, led by Florida, California, Texas.
Frequently Asked Questions
What is clinical trial NCT05631093 about?
NCT05631093 is a clinical study titled "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)". 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 b...
What is the current status of trial NCT05631093?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 553 participants. The study started on 2023-02-20. Estimated completion is 2028-07-11.
What conditions does trial NCT05631093 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT05631093?
The interventions under investigation include: ART (DRUG), DOR/ISL (DRUG).
Who is sponsoring clinical trial NCT05631093?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05631093 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Georgia, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV-1-infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05631093's enrollment target sits among peer trials
553 12th of 71 higher than 60 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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