672
Participants
Start Date
February 18, 2020
Primary Completion Date
September 8, 2021
Study Completion Date
August 26, 2024
DOR/ISL
A FDC of 100 mg DOR/ 0.75 mg ISL taken in tablet form, orally, once daily
ART
Baseline ART regimen will be administered as per approved label. ART medication will not be provided by the Sponsor; participants will provide their own ART medications. Allowed drug classes include nucleoside analog reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transferase inhibitors (InSTIs), fusion inhibitors, chemokine receptor 5 (CCR5) antagonists, post-attachment inhibitor, and pharmacokinetic (PK) boosters.
Hopitaux Universitaires de Geneve HUG. ( Site 3304), Geneva
Holdsworth House Medical Practice ( Site 2300), Sydney
Inselspital Universitaetsspital Bern ( Site 3303), Bern
Melbourne Sexual Health Centre ( Site 2305), Carlton
Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 2309), Herston
Universitaetsspital Basel ( Site 3302), Basel
Fiona Stanley Hospital ( Site 2301), Murdoch
Ospedale Regionale di Lugano Civico ( Site 3305), Lugano
Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1414), Cape Town
Christchurch Hospital ( Site 2303), Christchurch
Universitaetsspital Zuerich ( Site 3300), Zurich
Kantonsspital St. Gallen ( Site 3301), Sankt Gallen
JOSHA Research ( Site 1406), Bloemfontein
University of Pennsylvania ( Site 1038), Philadelphia
Georgetown University Hospital ( Site 1018), Washington D.C.
ASST Fatebenefratelli-Ospedale Sacco ( Site 2200), Milan
Hopital Francois Mitterrand ( Site 2019), Dijon
University of North Carolina at Chapel Hill ( Site 1042), Chapel Hill
Hospital General Universitario Gregorio Maranon ( Site 1603), Madrid
Hospital Universitario Infanta Leonor ( Site 1601), Madrid
Hospital Universitario Fundacion Jimenez Diaz ( Site 1602), Madrid
Hospital Universitario La Paz ( Site 1604), Madrid
CHU de Toulouse - Hopital Purpan ( Site 2004), Toulouse
Chatham County Health Department ( Site 1043), Savannah
Orlando Immunology Center ( Site 1007), Orlando
Bliss Healthcare Services ( Site 1025), Orlando
CHU de Bordeaux- Hopital Saint Andre ( Site 2015), Bordeaux
Triple O Research Institute, P.A. ( Site 1026), West Palm Beach
Midway Immunology and Research ( Site 1030), Ft. Pierce
CHU Hotel Dieu Nantes ( Site 2020), Nantes
Northstar Healthcare ( Site 1002), Chicago
Kansas City CARE Health Center ( Site 1008), Kansas City
Hopital de la Croix-Rousse ( Site 2027), Lyon
A.P.H. Paris, Hopital Saint Louis ( Site 2014), Paris
North Texas ID Consultants, PA ( Site 1003), Dallas
CHU de Rouen ( Site 2005), Rouen
Texas Centers for Infectious Disease Associates P.A. ( Site 1022), Fort Worth
The Crofoot Research Center, Inc. ( Site 1005), Houston
Saint Hope Foundation, Inc. ( Site 1037), Bellaire
A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 2208), Napoli
Federal Scientific Methodological AIDS Prevention and Control Center ( Site 1703), Moscow
Infectious Clinical Hospital #2 ( Site 1719), Moscow
Saint Petersburg Center for Prophylactic of AIDS and Inf. Diseases ( Site 1701), Saint Petersburg
FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 1700), Saint Petersburg
Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 1707), Kazan'
Regional Center for Prevent. and Control of AIDS and Inf. Diseases ( Site 1715), Yekaterinburg
Kemerovo Regional Center for the Prevention and Control of AIDS ( Site 1713), Kemerovo
Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 1712), Krasnoyarsk
Fundacion Valle del Lili ( Site 1201), Santiago de Cali
Hospital Dr. Hernan Henriquez Aravena ( Site 1305), Temuco
Clinica Arauco Salud ( Site 1300), Santiago
Centro de Investigacion Clinica UC CICUC ( Site 1303), Santiago
ID Care ( Site 1023), Hillsborough
Southern Alberta HIV Clinic ( Site 1108), Calgary
Vancouver ID Research and Care Centre Society ( Site 1100), Vancouver
Hamilton Health Sciences ( Site 1103), Hamilton
Maple Leaf Research ( Site 1112), Toronto
Toronto General Hospital - University Health Network ( Site 1105), Toronto
Clinique de Medecine Urbaine du Quartier Latin ( Site 1104), Montreal
Clinique Medicale L Actuel ( Site 1114), Montreal
Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 2206), Roma
National Hospital Organization Nagoya Medical Center ( Site 2403), Nagoya
National Hospital Organization Osaka National Hospital ( Site 2402), Osaka
Tokyo Metropolitan Komagome Hospital ( Site 2406), Tokyo
Tokyo Medical University Hospital ( Site 2404), Tokyo
Center Hospital of the National Center for Global Health and Medicine ( Site 2401), Tokyo
EMC Instytut Medyczny SA Przychodnia przy ul. Lowieckiej we Wroclawiu ( Site 1500), Wroclaw
SP ZOZ Wojewodzki Szpital Zakazny ( Site 1505), Warsaw
Wroclawskie Centrum Zdrowia SP ZOZ ( Site 1507), Wroclaw
Wojewodzki Szpital Specjalistyczny im. dr. Wladyslawa Bieganskiego ( Site 1503), Lodz-Baluty
Hospital General de Elche ( Site 1608), Elche
Hospital Universitari Germans Trias i Pujol ( Site 1606), Badalona
Hospital Clinic i Provincial ( Site 1600), Barcelona
Brighton and Sussex University Hospital NHS Trust ( Site 1908), Brighton
Southmead Hospital ( Site 1910), Bristol
Royal Free Hospital ( Site 1904), London
Kings College Hospital NHS Foundation Trust ( Site 1907), London
North Manchester General Hospital ( Site 1902), Manchester
Merck Sharp & Dohme LLC
INDUSTRY