Phase
Condition
Hiv/aids
Hiv Infections
Treatment
BIC/FTC/TAF
DOR/ISL
Placebo to DOR/ISL
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Is human immunodeficiency virus type 1 (HIV-1) positive
Is naïve to antiretroviral therapy (ART) defined as having received ≤10 days ofprior therapy with any antiretroviral agent following a diagnosis of HIV-1 infectionincluding prevention of mother-to-child transmission up to 1 month prior toscreening.
A female participant is eligible to participate if she is not pregnant orbreastfeeding, and at least one of the following conditions applies: 1) Is not awoman of childbearing potential (WOCBP); 2) Is a WOCBP and using an acceptablecontraceptive method, or be abstinent from heterosexual intercourse as theirpreferred and usual lifestyle (abstinent on a long term and persistent basis); 3) AWOCBP must have a negative highly sensitive pregnancy test ([urine or serum] asrequired by local regulations) within 24 hours before the first dose of studyintervention; 4) If a urine test cannot be confirmed as negative (eg, an ambiguousresult), a serum pregnancy test is required
Exclusion
Exclusion Criteria:
Has HIV-2 infection
Has hypersensitivity or other contraindication to any of the components of the studyinterventions as determined by the investigator
Has an active diagnosis of hepatitis due to any cause, including active HBVinfection (defined as hepatitis B surface antigen [HBsAg]-positive or hepatitis Bvirus deoxyribonucleic acid [HBV DNA]-positive)
Has a history of malignancy ≤5 years prior to signing informed consent except foradequately treated basal cell or squamous cell skin cancer, in situ cervical cancer,or cutaneous Kaposi's sarcoma
Has a history or current evidence of any condition (including active tuberculosisinfection), therapy, laboratory abnormality or other circumstance (including drug oralcohol use or dependence) that might, in the opinion of the investigator, confoundthe results of the study or interfere with the participant's participation for thefull duration of the study
Has been treated for a viral infection other than HIV-1, such as hepatitis B, withan agent that is active against HIV-1
Is taking or is anticipated to require systemic immunosuppressive therapy, immunemodulators, or any prohibited therapy from 45 days prior to Day 1 through the studyintervention period
Is currently participating in or has participated in a clinical study with aninvestigational compound or device from 45 days prior to Day 1 through the studyintervention period
Has a documented or known virologic resistance to any approved HIV-1 reversetranscriptase inhibitor, or any study intervention
Has exclusionary laboratory values within 45 days prior to Day 1
Is female and is expecting to conceive or donate eggs at any time during the study
Study Design
Study Description
Connect with a study center
IDEAA Foundation ( Site 5807)
Buenos Aires, Caba C1405CKC
ArgentinaSite Not Available
Fundación Huesped ( Site 5801)
C.a.b.a, Caba C1202ABB
ArgentinaSite Not Available
Helios Salud S.A. ( Site 5802)
Ciudad Autonoma de Buenos Aires, Caba C1141ACG
ArgentinaSite Not Available
Instituto CAICI ( Site 5803)
Rosario, Santa Fe S2000PBJ
ArgentinaSite Not Available
Instituto Oulton ( Site 5804)
Cordoba, X5000JJS
ArgentinaSite Not Available
Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 5703)
Hamilton, Ontario L8S 14K
CanadaSite Not Available
Toronto General Hospital - University Health Network ( Site 5705)
Toronto, Ontario M5G 2N2
CanadaSite Not Available
Clinique Medicale L Actuel ( Site 5714)
Montreal, Quebec H2L 4P9
CanadaSite Not Available
McGill University Health Center - Research Institute-CVIS Clinical Research Unit ( Site 5702)
Montreal, Quebec H4A 3J1
CanadaSite Not Available
Hospital Dr. Hernan Henriquez Aravena ( Site 5905)
Temuco, Araucania 4781151
ChileSite Not Available
Clinica Universidad Catolica del Maule ( Site 5909)
Talca, Maule 3460000
ChileSite Not Available
Centro Cardiovascular Cardiosur ( Site 5907)
Santiago, Region M. De Santiago 8910259
ChileSite Not Available
Clinica Arauco Salud ( Site 5900)
Santiago, Region M. De Santiago 7560994
ChileSite Not Available
Fundacion Arriaran ( Site 5901)
Santiago, Region M. De Santiago 8360159
ChileSite Not Available
Hospital Clinico de la Universidad Catolica ( Site 5903)
Santiago, Region M. De Santiago 8331150
ChileSite Not Available
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 6006)
Bogota, Distrito Capital De Bogota 111321
ColombiaSite Not Available
Hospital Universitario San Ignacio ( Site 6005)
Bogota, Distrito Capital De Bogota 110231
ColombiaSite Not Available
Fundacion Valle del Lili ( Site 6001)
Cali, Valle Del Cauca 760032
ColombiaSite Not Available
A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 6124)
Paris, Ain 75018
FranceSite Not Available
Centre Hospitalier Regional du Orleans ( Site 6108)
Orleans, Centre 45000
FranceSite Not Available
Hopital Francois Mitterrand ( Site 6119)
Dijon, Cote-d Or 21079
FranceSite Not Available
CHU de Bordeaux. Hopital Pellegrin ( Site 6116)
Bordeaux, Gironde 33076
FranceSite Not Available
Centre Hospitalier de Tourcoing ( Site 6100)
Tourcoing, Nord 59208
FranceSite Not Available
Hopital de la Croix-Rousse ( Site 6127)
Lyon, Rhone-Alpes 69004
FranceSite Not Available
Hopital Avicenne ( Site 6102)
Bobigny, Seine-Saint-Denis 93000
FranceSite Not Available
A.P.H. Paris, Hopital Saint Louis ( Site 6114)
Paris, 75010
FranceSite Not Available
Hopital Pitie Salpetriere ( Site 6111)
Paris, 75013
FranceSite Not Available
Hopital Saint-Antoine ( Site 6113)
Paris, 75012
FranceSite Not Available
Universitaetsklinik Freiburg ( Site 6206)
Freiburg, Baden-Wurttemberg 79106
GermanySite Not Available
Klinikum der LMU München ( Site 6204)
Muenchen, Bayern 80336
GermanySite Not Available
MVZ Munchen am Goetheplatz ( Site 6202)
Muenchen, Bayern 80337
GermanySite Not Available
Infektiologikum ( Site 6201)
Frankfurt am Main, Hessen 60596
GermanySite Not Available
Universitaetsklinikum Bonn ( Site 6200)
Bonn, Nordrhein-Westfalen 53127
GermanySite Not Available
EPIMED- Ges. f. epidemiolog. u. klin. Forschung in der Medizin mbH ( Site 6208)
Berlin, 10787
GermanySite Not Available
Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 6210)
Hamburg, 20246
GermanySite Not Available
Rambam Medical Center ( Site 6701)
Haifa, 3109601
IsraelSite Not Available
Hadassah Ein Kerem Medical Center ( Site 6702)
Jerusalem, 9112001
IsraelSite Not Available
Chaim Sheba Medical Center. ( Site 6704)
Ramat-Gan, 5265601
IsraelSite Not Available
Kaplan Medical Center ( Site 6700)
Rehovot, 7610001
IsraelSite Not Available
Sourasky Medical Center ( Site 6705)
Tel Aviv, 64239
IsraelSite Not Available
A.O.R.N. dei Colli - Ospedale Cotugno ( Site 6407)
Napoli, Campania 80131
ItalySite Not Available
Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 6404)
Modena, Emilia-Romagna 41124
ItalySite Not Available
ASST Papa Giovanni XXIII ( Site 6411)
Bergamo, Lombardia 24127
ItalySite Not Available
Ospedale San Gerardo ASST Monza ( Site 6412)
Monza, Monza E Brianza 20900
ItalySite Not Available
Ospedale Amedeo di Savoia ( Site 6414)
Torino, Piemonte 10149
ItalySite Not Available
ASST Fatebenefratelli-Ospedale Sacco ( Site 6400)
Milano, 20157
ItalySite Not Available
Azienda Ospedaliera San Paolo ( Site 6403)
Milano, 20142
ItalySite Not Available
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 6401)
Milano, 20122
ItalySite Not Available
Salute San Raffaele ( Site 6402)
Milano, 20127
ItalySite Not Available
IRCCS Policlinico San Matteo ( Site 6410)
Pavia, 27100
ItalySite Not Available
Azienda USL di Pescara-Presidio Ospedaliero di Pescara ( Site 6413)
Pescara, 65129
ItalySite Not Available
Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 6405)
Roma, 00149
ItalySite Not Available
National Hospital Organization Nagoya Medical Center ( Site 6903)
Nagoya, Aichi 460-0001
JapanSite Not Available
Kumamoto University Hospital ( Site 6905)
Kumamoto, 860-8556
JapanSite Not Available
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 69
Osaka, 540-0006
JapanSite Not Available
Center Hospital of the National Center for Global Health and Medicine ( Site 6901)
Tokyo, 162-8655
JapanSite Not Available
Tokyo Medical University Hospital ( Site 6904)
Tokyo, 160-0023
JapanSite Not Available
JOSHA Research ( Site 6605)
Bloemfontein, Free State 9301
South AfricaSite Not Available
Chris Hani Baragwanath Hospital - ICU ( Site 6608)
Johannesburg, Gauteng 1862
South AfricaSite Not Available
Ezintsha ( Site 6609)
Johannesburg, Gauteng 2193
South AfricaSite Not Available
Wits Health Consortium. Clinical HIV Research Unit ( Site 6614)
Johannesburg, Gauteng 2041
South AfricaSite Not Available
Wentworth Hospital ( Site 6607)
Durban, Kwazulu-Natal 4052
South AfricaSite Not Available
Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 6613)
Cape Town, Western Cape 7925
South AfricaSite Not Available
Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6617)
Cape Town, Western Cape 7500
South AfricaSite Not Available
Be Part Yoluntu Centre ( Site 6603)
Mbekweni, Paarl, Western Cape 7646
South AfricaSite Not Available
Hospital General de Elche ( Site 6308)
Elche, Alicante 03202
SpainSite Not Available
Hospital Universitari Germans Trias i Pujol ( Site 6301)
Badalona, Barcelona 08916
SpainSite Not Available
Hospital Universitari de Bellvitge ( Site 6312)
LHospitalet de Llobregat, Barcelona 08907
SpainSite Not Available
Hospital Clinic i Provincial ( Site 6300)
Barcelona, Cataluna 08036
SpainSite Not Available
Hospital Vall D Hebron ( Site 6302)
Barcelona, Cataluna 08035
SpainSite Not Available
Hospital General Universitario Gregorio Maranon ( Site 6303)
Madrid, 28007
SpainSite Not Available
Hospital Universitario 12 de Octubre ( Site 6305)
Madrid, 28041
SpainSite Not Available
Hospital Universitario Fundacion Jimenez Diaz ( Site 6307)
Madrid, 28040
SpainSite Not Available
Hospital Universitario La Paz ( Site 6304)
Madrid, 28046
SpainSite Not Available
Hospital Universitario Virgen de la Victoria ( Site 6309)
Malaga, 29010
SpainSite Not Available
Kaohsiung Veterans General Hospital ( Site 7102)
Kaohsiung, 81362
TaiwanSite Not Available
National Cheng Kung University Hospital ( Site 7101)
Tainan, 70403
TaiwanSite Not Available
National Taiwan University Hospital ( Site 7100)
Taipei, 100
TaiwanSite Not Available
University of Alabama at Birmingham 1917 Research Clinic ( Site 5610)
Birmingham, Alabama 35222
United StatesSite Not Available
Pueblo Family Physicians ( Site 5606)
Phoenix, Arizona 85015
United StatesSite Not Available
Ruane Clinical Research Group, Inc. ( Site 5624)
Los Angeles, California 90036
United StatesSite Not Available
Midway Immunology and Research ( Site 5622)
Fort Pierce, Florida 34982
United StatesSite Not Available
Floridian Clinical Research, LLC ( Site 5625)
Hialeah, Florida 33016
United StatesSite Not Available
The Kinder Medical Group ( Site 5615)
Miami, Florida 33133
United StatesSite Not Available
Floridian Clinical Research, LLC ( Site 5625)
Miami Lakes, Florida 33016
United StatesSite Not Available
Orlando Immunology Center ( Site 5613)
Orlando, Florida 32803
United StatesSite Not Available
CAN Community Health ( Site 5627)
Sarasota, Florida 34237
United StatesSite Not Available
Triple O Research Institute, P.A. ( Site 5621)
West Palm Beach, Florida 33407
United StatesSite Not Available
Columbus Regional Research Institute ( Site 5616)
Columbus, Georgia 31904
United StatesSite Not Available
Infectious Disease Specialists Of Atlanta PC ( Site 5608)
Decatur, Georgia 30033
United StatesSite Not Available
Hennepin Healthcare-Hennepin Healthcare-ID ( Site 5633)
Minneapolis, Minnesota 55415
United StatesSite Not Available
Kansas City CARE Clinic ( Site 5607)
Kansas City, Missouri 64111
United StatesSite Not Available
University of Pennsylvania ( Site 5630)
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Saint Hope Foundation, Inc. ( Site 5629)
Bellaire, Texas 77401
United StatesSite Not Available
North Texas ID Consultants, PA ( Site 5604)
Dallas, Texas 75246
United StatesSite Not Available
Texas Centers for Infectious Disease Associates P.A. ( Site 5619)
Fort Worth, Texas 76104
United StatesSite Not Available

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