Open-label, Follow-up of Doravirine/Islatravir for Participants With Human Immunodeficiency Virus -1 (HIV-1) Infection (MK-8591A-033)
Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04776252
Collaborator
(none)
2,000
88
1
83
22.7
0.3
Study Details
Study Description
Brief Summary
The safety and tolerability of MK-8591A, a novel 2-drug fixed dose combination (FDC) of doravirine (DOR) and islatravir (ISL) will be evaluated in adult and pediatric participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
2000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Open-label Rollover Clinical Study of Doravirine/Islatravir (DOR/ISL) Once-daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL in a Phase 2 or Phase 3 DOR/ISL Clinical Study
Actual Study Start Date
:
Sep 15, 2021
Anticipated Primary Completion Date
:
Nov 25, 2025
Anticipated Study Completion Date
:
Aug 14, 2028
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MK-8591A Fixed dose combination (FDC) tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for 96 weeks. |
Drug: MK-8591A
FDC tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for 96 weeks
|
Outcome Measures
Primary Outcome Measures
- Participants with serious adverse events (SAEs) [Up to Week 102]
Percentage of participants with serious adverse events (SAEs)
- Participants who discontinued due to an adverse event (AE) [Up to Week 96]
Percentage of participants who discontinued study treatment due to an AE.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Is currently receiving DOR/ISL adult FDC tablet in a MSD-sponsored clinical study and has completed the last treatment visit.
-
Is considered by the investigator to have derived clinical benefit from receiving DOR/ISL and for whom further treatment with DOR/ISL is considered clinically appropriate.
-
Is male or female and ≥35 kg at the time of signing the informed consent/assent.
-
Female is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP); or is a non-pregnant WOCBP who agrees to the following during the intervention period and for at least 6 weeks after the last dose of study intervention: Not be sexually active, or if sexually active, to use an acceptable method of contraception; or is pregnant and continues to receive study intervention (where allowed by local regulations and as appropriate based on available data/local standard-of-care guidelines)
Exclusion Criteria:
- Is taking or is anticipated to require any prohibited therapies.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pueblo Family Physicians ( Site 0010) | Phoenix | Arizona | United States | 85015 |
| 2 | One Community Health ( Site 0045) | Sacramento | California | United States | 95811 |
| 3 | Whitman-Walker Institute ( Site 0039) | Washington | District of Columbia | United States | 20005 |
| 4 | Georgetown University Medical Center-Clinical Trials Unit Division of Infectious Diseases ( Site 002 | Washington | District of Columbia | United States | 20007 |
| 5 | Midway Immunology and Research Center ( Site 0033) | Fort Pierce | Florida | United States | 34982 |
| 6 | Orlando Immunology Center ( Site 0017) | Orlando | Florida | United States | 32803 |
| 7 | Bliss Healthcare Services-Research ( Site 0030) | Orlando | Florida | United States | 32806 |
| 8 | Triple O Research Institute, P.A ( Site 0031) | West Palm Beach | Florida | United States | 33407 |
| 9 | Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 0015) | Savannah | Georgia | United States | 31401 |
| 10 | Northstar Healthcare ( Site 0003) | Chicago | Illinois | United States | 60657 |
| 11 | KC CARE Health Center-Clinical Trials ( Site 0012) | Kansas City | Missouri | United States | 64111 |
| 12 | ID Care ( Site 0028) | Hillsborough | New Jersey | United States | 08844 |
| 13 | Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site | Philadelphia | Pennsylvania | United States | 19104 |
| 14 | St Hope Foundation ( Site 0041) | Bellaire | Texas | United States | 77401 |
| 15 | North Texas Infectious Diseases Consultants, P.A-Research ( Site 0004) | Dallas | Texas | United States | 75246 |
| 16 | Texas Center for Infectious Disease Associates-Clinical Research ( Site 0026) | Fort Worth | Texas | United States | 76104 |
| 17 | The Crofoot Research Center ( Site 0008) | Houston | Texas | United States | 77098 |
| 18 | Holdsworth House Medical Practice ( Site 0700) | Darlinghurst | New South Wales | Australia | 2010 |
| 19 | St Vincent's Hospital-IBAC ( Site 0702) | Sydney | New South Wales | Australia | 2010 |
| 20 | Fiona Stanley Hospital ( Site 0706) | Murdoch | Western Australia | Australia | 6150 |
| 21 | Sheldon M. Chumir Health Centre-Southern Alberta Clinic ( Site 0106) | Calgary | Alberta | Canada | T2R 0X7 |
| 22 | Vancouver Infectious Diseases Centre ( Site 0100) | Vancouver | British Columbia | Canada | V6Z 2C7 |
| 23 | Hamilton General Hospital-Special Immunology Services Clinic ( Site 0109) | Hamilton | Ontario | Canada | L8L 2X2 |
| 24 | Maple Leaf Research ( Site 0105) | Toronto | Ontario | Canada | M5G 1K2 |
| 25 | Toronto General Hospital ( Site 0104) | Toronto | Ontario | Canada | M5G 2C4 |
| 26 | Clinique de médecine Urbaine du Quartier Latin ( Site 0110) | Montreal | Quebec | Canada | H2L 4E9 |
| 27 | Clinique Medicale lActuel ( Site 0108) | Montreal | Quebec | Canada | H2L 4P9 |
| 28 | Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0202) | Temuco | Araucania | Chile | 4781151 |
| 29 | Biomedica Research Group-Infectology ( Site 0201) | Santiago | Region M. De Santiago | Chile | 7500710 |
| 30 | Centro de Investigacion Clinicadela Universidad Catolica ( Site 0204) | Santiago | Region M. De Santiago | Chile | 8330034 |
| 31 | Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0200) | Santiago | Region M. De Santiago | Chile | 8380420 |
| 32 | Fundacion Valle del Lili- CIC ( Site 0300) | Cali | Valle Del Cauca | Colombia | 760032 |
| 33 | Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1504) | Nice | Alpes-Maritimes | France | 06202 |
| 34 | Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1516) | Dijon | Cote-d Or | France | 21000 |
| 35 | CHU de Bordeaux Hop St ANDRE-Médecine interne et maladies infectieuses ( Site 1512) | Bordeaux | Gironde | France | 33075 |
| 36 | CHU de Toulouse-Infectious Disease-Tropical Diseases ( Site 1505) | Toulouse | Haute-Garonne | France | 31400 |
| 37 | CHU Charles Nicolle-Inefectious disease ( Site 1506) | Rouen | Haute-Normandie | France | 76031 |
| 38 | Hospital La Colombière ( Site 1518) | Montpellier | Herault | France | 34090 |
| 39 | Hôpital Avicenne ( Site 1502) | Bobigny | Ile-de-France | France | 93000 |
| 40 | Hôpital Saint-Louis-Infectious Diseases and tropical diseases ( Site 1511) | Paris | Ile-de-France | France | 75010 |
| 41 | Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 1508) | Paris | Ile-de-France | France | 75013 |
| 42 | Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 1517) | Nantes | Loire-Atlantique | France | 44093 Cedex 1 |
| 43 | Tourcoing Hospital-Service Universitaire des Maladies Infectieuses et du Voyageur ( Site 1519) | Tourcoing | Nord | France | 59200 |
| 44 | Hôpital de la Croix Rousse-Service des Maladies infectieuses et tropicales ( Site 1503) | Lyon | Rhone | France | 69004 |
| 45 | Hôpital Bichat - Claude-Bernard-infectious diseases ( Site 1523) | Paris | France | 75018 | |
| 46 | Fondazione Policlinico Universitario Agostino Gemelli-UOC Malattie Infettive ( Site 1606) | Roma | Lazio | Italy | 00168 |
| 47 | Ospedale Luigi Sacco-UOC Malattie Infettive I ( Site 1600) | Milan | Milano | Italy | 20157 |
| 48 | National Hospital Organization Nagoya Medical Center ( Site 0903) | Nagoya | Aichi | Japan | 460-0001 |
| 49 | Tokyo Medical University Hospital ( Site 0904) | Shinjuku-ku | Tokyo | Japan | 160-0023 |
| 50 | Center Hospital of the National Center for Global Health and Medicine ( Site 0901) | Shinjyuku-ku | Tokyo | Japan | 162-8655 |
| 51 | National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 09 | Osaka | Japan | 540-0006 | |
| 52 | Tokyo Metropolitan Komagome Hospital ( Site 0906) | Tokyo | Japan | 113-8677 | |
| 53 | Christchurch Hospital-Infectious Diseases ( Site 0800) | Christchurch | Canterbury | New Zealand | 8011 |
| 54 | Wrocl.Centr.Zdrowia SPZOZ Osr. Prof-Lecz Ch. Zak. i Terapii Uzaleznien ( Site 1703) | Wroclaw | Dolnoslaskie | Poland | 50-136 |
| 55 | EMC Instytut Medyczny S. A. Przychodnia przy ul. Lowieckiej we Wroclawiu ( Site 1700) | Wrocław | Dolnoslaskie | Poland | 50-220 |
| 56 | WSS im. W Bieganskiego O. Chorob Zakaznych i Hepatologii-F ( Site 1701) | Ód | Lodzkie | Poland | 90-001 |
| 57 | Wojewódzki Szpital Zakaźny w Warszawie ( Site 1702) | Warsaw | Mazowieckie | Poland | 01-201 |
| 58 | Kemerovo Regional Center for the Prevention and Control of AIDS and Infectious Diseases ( Site 2305) | Kemerovo | Kemerovskaya Oblast | Russian Federation | 650056 |
| 59 | Krasnoyarsk Regional Center for the Prevention and Control of AIDS ( Site 2304) | Krasnoyarsk | Krasnoyarskiy Kray | Russian Federation | 660049 |
| 60 | Republican Clinical Infectious Hospital ( Site 2300) | Saint Petersburg | Leningradskaya Oblast | Russian Federation | 196645 |
| 61 | Moscow Infectious Diseases Clinical Hospital Number 2 ( Site 2306) | Moscow | Moskva | Russian Federation | 105275 |
| 62 | Scientific Advisory Clinical Diagnostic Center Central Resea-Federal AIDS Center ( Site 2302) | Moscow | Moskva | Russian Federation | 105275 |
| 63 | Saint-Petersburg Center for Prophylactic of AIDS and Infecti-Saint-Petersburg Center for Prophylact | Saint Petersburg | Sankt-Peterburg | Russian Federation | 190020 |
| 64 | Smolensk Center for prevention and control of AIDS ( Site 2308) | Smolensk | Smolenskaya Oblast | Russian Federation | 214006 |
| 65 | Republican Clinical Hospital for Infectious Diseases A.F. Agafonova ( Site 2303) | Kazan | Tatarstan, Respublika | Russian Federation | 420140 |
| 66 | Josha Research ( Site 2403) | Bloemfontein | Free State | South Africa | 9301 |
| 67 | Ezintsha ( Site 2404) | Johannesburg | Gauteng | South Africa | 2193 |
| 68 | Mediclinc Muelmed ( Site 2401) | Pretoria | Gauteng | South Africa | 0083 |
| 69 | Wentworth Hospital ( Site 2400) | Durban | Kwazulu-Natal | South Africa | 4052 |
| 70 | Desmond Tutu Health Foundation ( Site 2402) | Cape Town | Western Cape | South Africa | 7925 |
| 71 | Hospital General Universitario de Elche-Infectius Disease ( Site 1908) | Elche | Alicante | Spain | 03202 |
| 72 | Hospital Germans Trias i Pujol-Fundació Lluita contra la Sida ( Site 1901) | Badalona | Barcelona | Spain | 08916 |
| 73 | HOSPITAL CLÍNIC DE BARCELONA-Infection Day Hospital ( Site 1900) | Barcelona | Cataluna | Spain | 08036 |
| 74 | HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Unidad de Enfermedades Infecciosas ( Site 1903) | Madrid | Madrid, Comunidad De | Spain | 28007 |
| 75 | Hospital Universitario La Paz-Internal Medicine ( Site 1904) | Madrid | Madrid, Comunidad De | Spain | 28046 |
| 76 | Hospital Universitario Infanta Leonor ( Site 1906) | Madrid | Spain | 28031 | |
| 77 | Hospital Universitario Fundación Jiménez Díaz-Internal Medicine. Infectious disease ( Site 1902) | Madrid | Spain | 28040 | |
| 78 | University Hospital Basel-Infectiology ( Site 2002) | Basel | Basel-Stadt | Switzerland | 4056 |
| 79 | Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 2004) | Geneva | Geneve | Switzerland | 1211 |
| 80 | Cantonal Hospital St.Gallen ( Site 2001) | St.Gallen | Sankt Gallen | Switzerland | 9007 |
| 81 | Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 2005) | Lugano | Ticino | Switzerland | 6903 |
| 82 | UniversitätsSpital Zürich ( Site 2000) | Zürich | Zurich | Switzerland | 8091 |
| 83 | Inselspital Bern-Inselspital Infektiologie ( Site 2003) | Berne | Switzerland | 3010 | |
| 84 | Brighton and Sussex University Hospitals NHS Trust ( Site 2104) | East Sussex | Brighton And Hove | United Kingdom | BN2 5BE |
| 85 | Southmead Hospital ( Site 2103) | Bristol | Bristol, City Of | United Kingdom | BS10 5NB |
| 86 | Royal Free Hospital ( Site 2102) | London | England | United Kingdom | NW32QG |
| 87 | King's College Hospital ( Site 2101) | London | England | United Kingdom | SE5 9RS |
| 88 | North Manchester General Hospital ( Site 2105) | Crumpsall | Manchester | United Kingdom | M8 5RB |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:
NCT04776252
Other Study ID Numbers:
- 8591A-033
- MK-8591A-033
- jRCT2031210528
- 2020-001191-14
First Posted:
Mar 1, 2021
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: