NCT05631093Active, not recruitingPhase 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, 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
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 553 (actual)
- First submitted
- 18 Nov 2022
- Start date
- 20 Feb 2023
- Primary completion date
- 10 Oct 2024
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- HIV
- NCT number
- NCT05631093
- EU CT number
- 2022-502127-22-00
- EudraCT number
- 2022-502127-22
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 553
- From 20 Feb 2023 to the primary completion date, 10 Oct 2024
- 53 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has a diagnosis of an active acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 30 days prior to screening
- Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome P450 3A (CYP3A) inducers
- Is currently participating in or has participated in a clinical study and received (or is receiving) an investigational compound or device from 45 days prior to Day 1 through the study treatment period
Other illness
- Has HIV-2 infection
- Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
- Has active hepatitis B virus (HBV) infection
- Has chronic hepatitis C virus (HCV) infection consistent with cirrhosis
- Has taken long-acting HIV therapy at any time
Age
- Has a ≤5 years prior history of malignancy
Other
- Has a documented or known virologic resistance to Doravine (DOR)
Who the study is looking for
- Is Human Immunodeficiency Virus-1 (HIV-1) positive with plasma HIV-1 Ribonucleic Acid (RNA) \<50 copies/mL at screening
- Has been receiving continuous, stable oral 2-drug or 3-drug combination (± PK booster) antiretroviral therapy ART with documented viral suppression (HIV-1 RNA \<50 copies/mL) for ≥3 consecutive months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen
- Female is not a participant of childbearing potential (POCBP); or if a POCBP uses an acceptable contraceptive method or abstains from penile-vaginal intercourse as their preferred and usual lifestyle; has a negative highly sensitive pregnancy test; and whose medical history, menstrual history, and recent sexual activity has been reviewed by the investigator
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (53)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Holdsworth House Medical Practice - Brisbane ( Site 4201) Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| Royal Brisbane and Women's Hospital-Infectious Diseases Research ( Site 4204) Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| Holdsworth House Medical Practice ( Site 4200) Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| Prahran Market Clinic ( Site 4202) Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| St Vincent's Hospital-IBAC ( Site 4203) Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 3104) Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Clinique Medicale lActuel-Clinical Research ( Site 3100) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Clinique de médecine Urbaine du Quartier Latin ( Site 3101) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Toronto General Hospital ( Site 3102) Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Maple Leaf Research ( Site 3103) Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| University Hospital Basel-Infectiology ( Site 4002) Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Inselspital Bern-Inselspital Infektiologie ( Site 4003) Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 4004) Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| CHUV (centre hospitalier universitaire vaudois) ( Site 4006) Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 4005) Coordinator of this site? Confirm its status | Lugano | Switzerland | Unknown status |
| UniversitätsSpital Zürich ( Site 4000) Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Ciensalud Ips S A S ( Site 3300) Coordinator of this site? Confirm its status | Barranquilla | Colombia | Unknown status |
| Clinica de la Costa S.A.S. ( Site 3305) Coordinator of this site? Confirm its status | Barranquilla | Colombia | Unknown status |
| Fundacion Valle del Lili- CIC ( Site 3302) Coordinator of this site? Confirm its status | Cali | Colombia | Unknown status |
| Heartlands Hospital ( Site 4102) Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| North Manchester General Hospital ( Site 4107) Coordinator of this site? Confirm its status | Crumpsall | United Kingdom | Unknown status |
| Brighton and Sussex University Hospitals NHS Trust ( Site 4104) Coordinator of this site? Confirm its status | East Sussex | United Kingdom | Unknown status |
| Royal Free Hospital ( Site 4101) Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| King's College Hospital ( Site 4108) Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal London Hospital ( Site 4100) Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Victoria Infirmary ( Site 4105) Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| National Hospital Organization Nagoya Medical Center ( Site 4403) Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Tokyo Medical University Hospital ( Site 4404) Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Center Hospital of the National Center for Global Health and Medicine ( Site 4401) Coordinator of this site? Confirm its status | Shinjyuku-ku | Japan | Unknown status |
| Central Texas Clinical Research ( Site 3015) Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Infectious Disease Specialists of Atlanta ( Site 3003) Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Midway Immunology and Research Center ( Site 3009) Coordinator of this site? Confirm its status | Ft. Pierce | United States | Unknown status |
| ID Care ( Site 3041) Coordinator of this site? Confirm its status | Hillsborough | United States | Unknown status |
| The Crofoot Research Center ( Site 3040) Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| DCOL Center for Clinical Research ( Site 3022) Coordinator of this site? Confirm its status | Longview | United States | Unknown status |
| Kaiser Permanente-Infectious Disease ( Site 3014) Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Orlando Immunology Center ( Site 3004) Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Palmtree Clinical Research ( Site 3032) Coordinator of this site? Confirm its status | Palm Springs | United States | Unknown status |
| Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Zuckerberg San Francisco General Hospital and Trauma Center-UCSF ID Clinical Trials Center ( Site 30 Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| CAN Community Health - Sarasota ( Site 3017) Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
| Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3028) Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| Georgetown University Medical Center ( Site 3006) Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Triple O Research Institute, P.A ( Site 3026) Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
| Josha Research ( Site 3903) Coordinator of this site? Confirm its status | Bloemfontein | South Africa | Unknown status |
| Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 3908) Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Desmond Tutu Health Foundation ( Site 3902) Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Wentworth Hospital ( Site 3904) Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
| Helen Joseph Hospital ( Site 3910) Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 3905) Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Ezintsha-Clinical Research Site ( Site 3907) Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Be Part Yoluntu Centre ( Site 3901) Coordinator of this site? Confirm its status | Paarl | South Africa | Unknown status |
| Private Practice Dr. Marleen de Jager ( Site 3900) Coordinator of this site? Confirm its status | Pretoria | South Africa | Unknown status |
Related publications
- Switching to Daily Doravirine/Islatravir (100/0.25 mg) Maintains Viral Suppression Through Week 48 Despite Baseline Non-Nucleoside Reverse Transcriptase Inhibitor Resistance-Associated Mutations or M184I/V in Proviral DNA.J Infect Dis · 2026 · PMID 42213454
- Switch to fixed-dose doravirine (100 mg) and islatravir (0·25 mg) once daily in virologically suppressed adults with HIV-1 on oral antiretroviral therapy: 48-week results of a phase 3, multicentre, randomised, open-label, non-inferiority trial.Lancet · 2026 · PMID 41654374
This page is information, not medical advice. Discuss any trial with your doctor.