NCT05766501Active, not recruitingPhase 3
A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)
A Phase 3 Open-label Clinical Study of Doravirine/Islatravir (DOR/ISL [100 mg/0.25 mg]) Once Daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL (100 mg/0.75 mg) QD in a Phase 3 Clinical Study
Source: ClinicalTrials.gov · Last updated 17 Dec 2025
Brief summary (registry, in English)
The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 641 (actual)
- First submitted
- 1 Mar 2023
- Start date
- 17 Mar 2023
- Primary completion date
- 16 Oct 2025
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- HIV
- NCT number
- NCT05766501
- EU CT number
- 2022-502126-40-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 641
- From 17 Mar 2023 to the primary completion date, 16 Oct 2025
- 95 sites in 15 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
- Is a HTE participant receiving treatment in MK-8591A-019 or -033.
Other illness
- Has confirmed HIV-1 RNA ≥200 copies/mL in MSD DOR/ISL (100 mg/0.75 mg) MK-8591A-018 /-020, or at screening for participants entering from DOR/ISL (100 mg/0.75 mg) MK-8591A-033.
Lab values
- Has confirmatory laboratory findings for cluster of differentiation 4+ (CD4+) T-cell counts or lymphocyte counts in the prior DOR/ISL study that meet criteria for discontinuation of DOR/ISL.
Who the study is looking for
- Is currently receiving doravirine/islatravir (DOR/ISL) adult fixed dose combination (FDC) tablet in Merck Sharp \& Dohme (MSD)-sponsored clinical studies (MK-8591A-018, -020, and -033 \[except for heavily treatment-experienced (HTE) participants\]).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (95)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundación Huésped ( Site 1001) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Fundación IDEAA ( Site 1005) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Helios Salud ( Site 1002) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Instituto Oulton ( Site 1004) Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Instituto CAICI SRL ( Site 1003) Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Holdsworth House Medical Practice - Brisbane ( Site 1101) Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| Holdsworth House Medical Practice ( Site 1100) Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| Prahran Market Clinic ( Site 1102) Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| St Vincent's Hospital-IBAC ( Site 1103) Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Hamilton Health Sciences- Urgent Care Centre ( Site 1304) Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| McGill University Health Centre ( Site 1306) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Clinique de médecine Urbaine du Quartier Latin ( Site 1305) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Clinique Medicale lActuel ( Site 1303) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Toronto General Hospital ( Site 1300) Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Maple Leaf Research ( Site 1301) Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| University Hospital Basel-Infectiology ( Site 2802) Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Inselspital Bern-Inselspital Infektiologie ( Site 2803) Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 2804) Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 2805) Coordinator of this site? Confirm its status | Lugano | Switzerland | Unknown status |
| Cantonal Hospital St.Gallen ( Site 2801) Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Unknown status |
| UniversitätsSpital Zürich ( Site 2800) Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Cardio Sur ( Site 1409) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Pontificia Universidad Catolica de Chile ( Site 1407) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 1400) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Biomedica Research Group-Infectology ( Site 1401) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Clinica Universidad Catolica del Maule ( Site 1405) Coordinator of this site? Confirm its status | Talca | Chile | Unknown status |
| Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 1403) Coordinator of this site? Confirm its status | Temuco | Chile | Unknown status |
| Hospital Universitario San Ignacio-Infectious ( Site 1501) Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
| Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 1502) Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
| Fundación Valle del Lili ( Site 1500) Coordinator of this site? Confirm its status | Cali | Colombia | Unknown status |
| Southmead Hospital ( Site 3003) Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| North Manchester General Hospital ( Site 3005) Coordinator of this site? Confirm its status | Crumpsall | United Kingdom | Unknown status |
| University Hospitals Sussex NHS Foundation Trust ( Site 3004) Coordinator of this site? Confirm its status | East Sussex | United Kingdom | Unknown status |
| Royal Free Hospital ( Site 3002) Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| King's College Hospital ( Site 3001) Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 1901) Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah Medical Center-Infecious Disease ( Site 1902) Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Sheba Medical Center-HIV unit ( Site 1903) Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Sourasky Medical Center ( Site 1904) Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Tokyo Metropolitan Komagome Hospital ( Site 2105) Coordinator of this site? Confirm its status | Bunkyo | Japan | Unknown status |
| National Hospital Organization Nagoya Medical Center ( Site 2103) Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 21 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Tokyo Medical University Hospital ( Site 2104) Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Center Hospital of the National Center for Global Health and Medicine ( Site 2101) Coordinator of this site? Confirm its status | Shinjyuku-ku | Japan | Unknown status |
| Christchurch Hospital-Infectious Diseases ( Site 2200) Coordinator of this site? Confirm its status | Christchurch | New Zealand | Unknown status |
| Clinical Research Puerto Rico ( Site 2400) Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| HOPE Clinical Research ( Site 2401) Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Republican Clinical Hospital for Infectious Diseases A.F. Agafonova ( Site 2503) Coordinator of this site? Confirm its status | Kazan' | Russia | Unknown status |
| Kemerovo Regional Center for the Prevention and Control of AIDS and Infectious Diseases ( Site 2505) Coordinator of this site? Confirm its status | Kemerovo | Russia | Unknown status |
| Krasnoyarsk Regional Center for the Prevention and Control of AIDS ( Site 2504) Coordinator of this site? Confirm its status | Krasnoyarsk | Russia | Unknown status |
| Scientific Advisory Clinical Diagnostic Center Central Resea-Federal AIDS Center ( Site 2502) Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Moscow Infectious Diseases Clinical Hospital Number 2 ( Site 2506) Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Republican Clinical Infectious Hospital ( Site 2500) Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Saint-Petersburg Center for Prophylactic of AIDS and Infecti-Saint-Petersburg Center for Prophylact Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Kaohsiung Veterans General Hospital ( Site 2901) Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Augusta University-Infectious Diseases ( Site 3135) Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| St Hope Foundation ( Site 3121) Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Pacific Oaks Medical Group ( Site 3123) Coordinator of this site? Confirm its status | Beverly Hills | United States | Unknown status |
| University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 3104) Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| North Texas Infectious Diseases Consultants, P.A ( Site 3100) Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Infectious Disease Specialists of Atlanta ( Site 3128) Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Therafirst Medical Center ( Site 3110) Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Texas Centers for Infectious Disease Associates ( Site 3111) Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Midway Immunology and Research Center ( Site 3117) Coordinator of this site? Confirm its status | Ft. Pierce | United States | Unknown status |
| ID Care ( Site 3131) Coordinator of this site? Confirm its status | Hillsborough | United States | Unknown status |
| The Crofoot Research Center ( Site 3101) Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| KC CARE Health Center ( Site 3103) Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| DCOL Center for Clinical Research ( Site 3119) Coordinator of this site? Confirm its status | Longview | United States | Unknown status |
| Kaiser Permanente ( Site 3124) Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Ruane Clinical Research Group, Inc ( Site 3126) Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Mills Clinical Research ( Site 3114) Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Mercer university, Department of internal medicine-Clinical Research ( Site 3129) Coordinator of this site? Confirm its status | Macon | United States | Unknown status |
| AHF The Kinder Medical Group ( Site 3108) Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Floridian Clinical Research, LLC ( Site 3133) Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 3134) Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Bliss Healthcare Services ( Site 3115) Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Orlando Immunology Center ( Site 3106) Coordinator of this site? Confirm its status | Orlando | 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 |
| Pueblo Family Physicians ( Site 3102) Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| University of California Davis Health-Internal Medicine: Infectious Diseases ( Site 3137) Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| CAN Community Health - Sarasota ( Site 3118) Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
| Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3105) Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| Private Practice - Dr. Peter Shalit ( Site 3120) Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Multicare Institute for Research and Innovation ( Site 3127) Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Georgetown University Medical Center ( Site 3130) Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Triple O Research Institute, P.A ( Site 3116) Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
| Josha Research ( Site 2603) Coordinator of this site? Confirm its status | Bloemfontein | South Africa | Unknown status |
| Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 2608) Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Desmond Tutu Health Foundation ( Site 2602) Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Wentworth Hospital ( Site 2604) Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
| Helen Joseph Hospital-Clinical HIV Research Unit ( Site 2609) Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Ezintsha-Clinical Research Site ( Site 2607) Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 2605) Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Be Part Yoluntu Centre ( Site 2601) Coordinator of this site? Confirm its status | Paarl | South Africa | Unknown status |
| Private Practice Dr. Marleen de Jager ( Site 2600) Coordinator of this site? Confirm its status | Pretoria | South Africa | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.