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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8591A-054 | Other Identifier | MSD | |
| 2022-502126-40-00 | Registry Identifier | EU CT | |
| jRCT2051230002 | Registry Identifier | jRCT | |
| U1111-1283-3863 | Registry Identifier | UTN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DOR/ISL | Experimental | Participants will receive fixed dose combination (FDC) tablet of DOR/ISL (100 mg/0.25 mg) taken once daily (QD) orally from Day 1 to Week 96. After Week 96, eligible participants may continue on DOR/ISL until week 240 or until DOR/ISL becomes commercially accessible, whichever comes first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DOR/ISL | Drug | FDC tablet of 100 mg doravirine (DOR)/0.25 mg islatravir (ISL) taken once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with One or More Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE through Week 96 will be presented. | Up to 96 Weeks |
| Percentage of participants who Discontinue Study Intervention Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study intervention due to an AE through Week 96 will be presented. | Up to 96 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with HIV-1 Ribonucleic Acid (RNA) ≥50 copies/mL at Week 96 | The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96 will be reported. | Week 96 |
| Percentage of Participants with HIV-1 RNA <50 copies/mL at Week 96 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 3104) | Birmingham | Alabama | 35222 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42213454 | Derived | Diamond TL, Grandhi A, Fuszard M, Xu Y, Nwoke U, Zhang Y, Klopfer SO, Eves K, Benner J, Li M, Greaves W, Lahoulou R, Kim J, Fox MC, Asante-Appiah E. 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 May 29:jiag257. doi: 10.1093/infdis/jiag257. Online ahead of print. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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The percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 will be reported. |
| Week 96 |
| Percentage of Participants with HIV-1 RNA <200 copies/mL at Week 96 | The percentage of participants with HIV-1 RNA <200 copies/mL at Week 96 will be reported | Week 96 |
| Percentage of Participants with Evidence of Viral Drug Resistance-Associated Substitutions | Viral drug resistance is defined as participants with HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic data showing evidence of resistance to the study intervention. The percentage of participants who demonstrate drug resistance through Week 96 will be presented. | Up to Week 96 |
| Pueblo Family Physicians ( Site 3102) |
| Phoenix |
| Arizona |
| 85015 |
| United States |
| Pacific Oaks Medical Group ( Site 3123) | Beverly Hills | California | 90211 | United States |
| Kaiser Permanente ( Site 3124) | Los Angeles | California | 90027 | United States |
| Ruane Clinical Research Group, Inc ( Site 3126) | Los Angeles | California | 90036 | United States |
| Mills Clinical Research ( Site 3114) | Los Angeles | California | 90069 | United States |
| University of California Davis Health-Internal Medicine: Infectious Diseases ( Site 3137) | Sacramento | California | 95817 | United States |
| Georgetown University Medical Center ( Site 3130) | Washington D.C. | District of Columbia | 20007 | United States |
| Therafirst Medical Center ( Site 3110) | Fort Lauderdale | Florida | 33308 | United States |
| Midway Immunology and Research Center ( Site 3117) | Ft. Pierce | Florida | 34982 | United States |
| AHF The Kinder Medical Group ( Site 3108) | Miami | Florida | 33133 | United States |
| Floridian Clinical Research, LLC ( Site 3133) | Miami Lakes | Florida | 33016 | United States |
| Orlando Immunology Center ( Site 3106) | Orlando | Florida | 32803 | United States |
| Bliss Healthcare Services ( Site 3115) | Orlando | Florida | 32806 | United States |
| CAN Community Health - Sarasota ( Site 3118) | Sarasota | Florida | 34237 | United States |
| Triple O Research Institute, P.A ( Site 3116) | West Palm Beach | Florida | 33407 | United States |
| Augusta University-Infectious Diseases ( Site 3135) | Augusta | Georgia | 30912 | United States |
| Infectious Disease Specialists of Atlanta ( Site 3128) | Decatur | Georgia | 30033 | United States |
| Mercer university, Department of internal medicine-Clinical Research ( Site 3129) | Macon | Georgia | 31201 | United States |
| Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3105) | Savannah | Georgia | 31401 | United States |
| KC CARE Health Center ( Site 3103) | Kansas City | Missouri | 64111 | United States |
| ID Care ( Site 3131) | Hillsborough | New Jersey | 08844 | United States |
| Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 3134) | New York | New York | 10029 | United States |
| Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site | Philadelphia | Pennsylvania | 19104 | United States |
| St Hope Foundation ( Site 3121) | Bellaire | Texas | 77401 | United States |
| North Texas Infectious Diseases Consultants, P.A ( Site 3100) | Dallas | Texas | 75246 | United States |
| Texas Centers for Infectious Disease Associates ( Site 3111) | Fort Worth | Texas | 76104 | United States |
| The Crofoot Research Center ( Site 3101) | Houston | Texas | 77098 | United States |
| DCOL Center for Clinical Research ( Site 3119) | Longview | Texas | 75605 | United States |
| Private Practice - Dr. Peter Shalit ( Site 3120) | Seattle | Washington | 98104 | United States |
| Multicare Institute for Research and Innovation ( Site 3127) | Spokane | Washington | 99202 | United States |
| Instituto Oulton ( Site 1004) | Córdoba | Córdoba Province | X5000JJS | Argentina |
| Instituto CAICI SRL ( Site 1003) | Rosario | Santa Fe Province | S2000PBJ | Argentina |
| Helios Salud ( Site 1002) | Buenos Aires | C1141ACG | Argentina |
| Fundación Huésped ( Site 1001) | Buenos Aires | C1202ABB | Argentina |
| Fundación IDEAA ( Site 1005) | Buenos Aires | C1405CKC | Argentina |
| Holdsworth House Medical Practice ( Site 1100) | Darlinghurst | New South Wales | 2010 | Australia |
| St Vincent's Hospital-IBAC ( Site 1103) | Sydney | New South Wales | 2010 | Australia |
| Holdsworth House Medical Practice - Brisbane ( Site 1101) | Brisbane | Queensland | 4006 | Australia |
| Prahran Market Clinic ( Site 1102) | Melbourne | Victoria | 3181 | Australia |
| Hamilton Health Sciences- Urgent Care Centre ( Site 1304) | Hamilton | Ontario | L8S 1A4 | Canada |
| Maple Leaf Research ( Site 1301) | Toronto | Ontario | M5G 1K2 | Canada |
| Toronto General Hospital ( Site 1300) | Toronto | Ontario | M5G 2C4 | Canada |
| Clinique de médecine Urbaine du Quartier Latin ( Site 1305) | Montreal | Quebec | H2L 4E9 | Canada |
| Clinique Medicale lActuel ( Site 1303) | Montreal | Quebec | H2L 4P9 | Canada |
| McGill University Health Centre ( Site 1306) | Montreal | Quebec | H4A 3J1 | Canada |
| Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 1403) | Temuco | Araucania | 4781151 | Chile |
| Clinica Universidad Catolica del Maule ( Site 1405) | Talca | Maule Region | 3460000 | Chile |
| Biomedica Research Group-Infectology ( Site 1401) | Santiago | Region M. de Santiago | 7500710 | Chile |
| Pontificia Universidad Catolica de Chile ( Site 1407) | Santiago | Region M. de Santiago | 8330034 | Chile |
| Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 1400) | Santiago | Region M. de Santiago | 8380420 | Chile |
| Cardio Sur ( Site 1409) | Santiago | Region M. de Santiago | 8910259 | Chile |
| Hospital Universitario San Ignacio-Infectious ( Site 1501) | Bogotá | Bogota D.C. | 110231 | Colombia |
| Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 1502) | Bogotá | Bogota D.C. | 111321 | Colombia |
| Fundación Valle del Lili ( Site 1500) | Cali | Valle del Cauca Department | 760032 | Colombia |
| Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 1901) | Haifa | 3109601 | Israel |
| Hadassah Medical Center-Infecious Disease ( Site 1902) | Jerusalem | 9112001 | Israel |
| Sheba Medical Center-HIV unit ( Site 1903) | Ramat Gan | 5262100 | Israel |
| Sourasky Medical Center ( Site 1904) | Tel Aviv | 64239 | Israel |
| National Hospital Organization Nagoya Medical Center ( Site 2103) | Nagoya | Aichi-ken | 460-0001 | Japan |
| Tokyo Metropolitan Komagome Hospital ( Site 2105) | Bunkyo | Tokyo | 113-8677 | Japan |
| Tokyo Medical University Hospital ( Site 2104) | Shinjuku-ku | Tokyo | 160-0023 | Japan |
| Center Hospital of the National Center for Global Health and Medicine ( Site 2101) | Shinjyuku-ku | Tokyo | 162-8655 | Japan |
| National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 21 | Osaka | 540-0006 | Japan |
| Christchurch Hospital-Infectious Diseases ( Site 2200) | Christchurch | Canterbury | 8011 | New Zealand |
| Clinical Research Puerto Rico ( Site 2400) | San Juan | 00909 | Puerto Rico |
| HOPE Clinical Research ( Site 2401) | San Juan | 00909 | Puerto Rico |
| Kemerovo Regional Center for the Prevention and Control of AIDS and Infectious Diseases ( Site 2505) | Kemerovo | Kemerovo Oblast | 650056 | Russia |
| Krasnoyarsk Regional Center for the Prevention and Control of AIDS ( Site 2504) | Krasnoyarsk | Krasnoyarsk Krai | 660049 | Russia |
| Republican Clinical Infectious Hospital ( Site 2500) | Saint Petersburg | Leningradskaya Oblast' | 196645 | Russia |
| Moscow Infectious Diseases Clinical Hospital Number 2 ( Site 2506) | Moscow | Moscow | 105275 | Russia |
| Scientific Advisory Clinical Diagnostic Center Central Resea-Federal AIDS Center ( Site 2502) | Moscow | Moscow | 115035 | Russia |
| Saint-Petersburg Center for Prophylactic of AIDS and Infecti-Saint-Petersburg Center for Prophylact | Saint Petersburg | Sankt-Peterburg | 190020 | Russia |
| Republican Clinical Hospital for Infectious Diseases A.F. Agafonova ( Site 2503) | Kazan' | Tatarstan, Respublika | 420140 | Russia |
| Josha Research ( Site 2603) | Bloemfontein | Free State | 9301 | South Africa |
| Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 2605) | Johannesburg | Gauteng | 2013 | South Africa |
| Helen Joseph Hospital-Clinical HIV Research Unit ( Site 2609) | Johannesburg | Gauteng | 2092 | South Africa |
| Ezintsha-Clinical Research Site ( Site 2607) | Johannesburg | Gauteng | 2193 | South Africa |
| Private Practice Dr. Marleen de Jager ( Site 2600) | Pretoria | Gauteng | 0083 | South Africa |
| Wentworth Hospital ( Site 2604) | Durban | KwaZulu-Natal | 4052 | South Africa |
| Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 2608) | Cape Town | Western Cape | 7505 | South Africa |
| Desmond Tutu Health Foundation ( Site 2602) | Cape Town | Western Cape | 7925 | South Africa |
| Be Part Yoluntu Centre ( Site 2601) | Paarl | Western Cape | 7646 | South Africa |
| University Hospital Basel-Infectiology ( Site 2802) | Basel | Canton of Basel-City | 4056 | Switzerland |
| Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 2804) | Geneva | Canton of Geneva | 1211 | Switzerland |
| Cantonal Hospital St.Gallen ( Site 2801) | Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
| UniversitätsSpital Zürich ( Site 2800) | Zurich | Canton of Zurich | 8091 | Switzerland |
| Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 2805) | Lugano | Canton Ticino | 6903 | Switzerland |
| Inselspital Bern-Inselspital Infektiologie ( Site 2803) | Bern | 3010 | Switzerland |
| Kaohsiung Veterans General Hospital ( Site 2901) | Kaohsiung City | 81362 | Taiwan |
| University Hospitals Sussex NHS Foundation Trust ( Site 3004) | East Sussex | Brighton And Hove | BN2 1ES | United Kingdom |
| Southmead Hospital ( Site 3003) | Bristol | Bristol, City of | BS10 5NB | United Kingdom |
| Royal Free Hospital ( Site 3002) | London | England | NW32QG | United Kingdom |
| King's College Hospital ( Site 3001) | London | London, City of | SE5 9RL | United Kingdom |
| North Manchester General Hospital ( Site 3005) | Crumpsall | Manchester | M8 5RB | United Kingdom |
| Plain Language Summary | View source |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000592662 | doravirine |
| C558823 | islatravir |
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