Phase
Condition
Hiv/aids
Hiv Infections
Treatment
Placebo to BIC/FTC/TAF
Placebo to DOR/ISL
DOR/ISL
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Is HIV-1 positive with plasma HIV-1 RNA ≥500 copies/mL at screening
Is naïve to antiretroviral therapy (ART) defined as having received no prior therapywith any antiretroviral agent following a diagnosis of HIV-1 infection
If female, is not a participant of childbearing potential (POCBP); or if a POCBP, isnot pregnant or breastfeeding, and is willing to use an acceptable contraceptivemethod or abstain from heterosexual intercourse for study duration
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 a diagnosis of an active AIDS-defining opportunistic infection within 30 daysprior to screening
Has active hepatitis B infection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA]-positive).
Has chronic hepatitis C virus (HCV) infection (detectable HCV ribonucleic acid [RNA]) and lab values are consistent with cirrhosis
Has a history of malignancy ≤5 years prior to providing documented informed consentexcept for adequately treated basal cell or squamous cell skin cancer, in situcervical 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 drugor alcohol use or dependence) that might, in the opinion of the investigator,confound the results of the study or interfere with the participant's participationfor the full duration of the study, such that it is not in the best interest of theparticipant to participate
Study Design
Connect with a study center
Fundación Huésped ( Site 5850)
Caba, Buenos Aires C1427CEA
ArgentinaSite Not Available
Instituto de Investigaciones Clínicas Mar del Plata ( Site 5854)
Mar del Plata, Buenos Aires B7600FZO
ArgentinaSite Not Available
Instituto CAICI SRL ( Site 5852)
Rosario, Santa Fe S2000PBJ
ArgentinaSite Not Available
Fundación IDEAA ( Site 5851)
Buenos Aires, C1405CKC
ArgentinaSite Not Available
Instituto Oulton ( Site 5853)
Cordoba, X5000JJS
ArgentinaSite Not Available
Hamilton Health Sciences-Urgent Care Centre ( Site 5750)
Hamilton, Ontario L8S 1A4
CanadaSite Not Available
Toronto General Hospital ( Site 5753)
Toronto, Ontario M5G 2C4
CanadaSite Not Available
Clinique Medicale lActuel ( Site 5752)
Montréal, Quebec H2L 4P9
CanadaSite Not Available
McGill University Health Centre ( Site 5751)
Montréal, Quebec H4A 3J1
CanadaSite Not Available
Regina General Hospital ( Site 5754)
Regina, Saskatchewan S4P 0W5
CanadaSite Not Available
Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 5955)
Temuco, Araucania 4781151
ChileSite Not Available
Clinica Universidad Catolica del Maule ( Site 5954)
Talca, Maule 3465584
ChileSite Not Available
Biomedica Research Group-Infectology ( Site 5951)
Santiago, Region M. De Santiago 7500710
ChileSite Not Available
Centro de Investigacion Clinicadela Universidad Catolica ( Site 5953)
Santiago, Region M. De Santiago 8330034
ChileSite Not Available
Espacio Eme ( Site 5952)
Santiago, Region M. De Santiago 7770086
ChileSite Not Available
Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 5950)
Santiago, Region M. De Santiago 8380420
ChileSite Not Available
Ciensalud Ips S A S ( Site 6050)
Barranquilla, Atlantico 08001
ColombiaSite Not Available
Clinica de la Costa S.A.S. ( Site 6055)
Barranquilla, Atlantico 080020
ColombiaSite Not Available
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 6051)
Bogota, Distrito Capital De Bogota 111321
ColombiaSite Not Available
Hospital Universitario San Ignacio-Infectious ( Site 6053)
Bogota, Distrito Capital De Bogota 110231
ColombiaSite Not Available
Hospital Universitario San Ignacio-Infectious ( Site 6053)
Bogotá, Distrito Capital De Bogota 110231
ColombiaSite Not Available
Fundación Valle del Lili ( Site 6052)
Cali, Valle Del Cauca 760032
ColombiaSite Not Available
Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 8250)
Santo Domingo De Guzman, Santo Domingo 10305
Dominican RepublicSite Not Available
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 6153)
Nice, Alpes-Maritimes 06202
FranceSite Not Available
Hôpital Avicenne ( Site 6160)
Bobigny, Ile-de-France 93000
FranceSite Not Available
Hôpital Saint-Louis ( Site 6159)
Paris, Ile-de-France 75010
FranceSite Not Available
Pitie Salpetriere University Hospital ( Site 6156)
Paris, Ile-de-France 75013
FranceSite Not Available
Tourcoing Hospital ( Site 6150)
Tourcoing, Nord 59200
FranceSite Not Available
Hôpital Bichat - Claude-Bernard ( Site 6162)
Paris, 75018
FranceSite Not Available
Hôpital Saint Antoine ( Site 6158)
Paris, 75571
FranceSite Not Available
Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Medizinische Klinik und Poliklinik IV, Sektio
München, Bayern 80336
GermanySite Not Available
Universitaetsklinikum Freiburg ( Site 6256)
Freiburg, Brandenburg 79106
GermanySite Not Available
Universitätsklinikum Bonn-Immunologie ( Site 6250)
Bonn, Nordrhein-Westfalen 53127
GermanySite Not Available
ICH Study Center GmbH & Co. KG ( Site 6259)
Hamburg, 20146
GermanySite Not Available
Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 6260)
Hamburg, 20246
GermanySite Not Available
CELAN,S.A ( Site 8351)
Guatemala, 01010
GuatemalaSite Not Available
CLINIPHARM ( Site 8352)
Guatemala, 01001
GuatemalaSite Not Available
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 8350)
Guatemala, 01009
GuatemalaSite Not Available
Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 6751)
Haifa, 3109601
IsraelSite Not Available
Hadassah Medical Center-Infecious Disease ( Site 6752)
Jerusalem, 9120
IsraelSite Not Available
Sheba Medical Center-HIV unit ( Site 6753)
Ramat Gan, 5262100
IsraelSite Not Available
Sourasky Medical Center ( Site 6754)
Tel Aviv, 6423906
IsraelSite Not Available
National Hospital Organization Nagoya Medical Center ( Site 6953)
Nagoya, Aichi 460-0001
JapanSite Not Available
Tokyo Medical University Hospital ( Site 6954)
Shinjuku-ku, Tokyo 160-0023
JapanSite Not Available
Center Hospital of the National Center for Global Health and Medicine ( Site 6951)
Shinjyuku-ku, Tokyo 162-8655
JapanSite Not Available
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 69
Osaka, 540-0006
JapanSite Not Available
National Hospital Organization Osaka National Hospital ( Site 6952)
Osaka, 540-0006
JapanSite Not Available
National Hospital Organization Osaka National Hospital. ( Site 6952)
Osaka, 540-0006
JapanSite Not Available
CCR KEMRI (Center for Clinical Research) ( Site 8652)
Nairobi, Nairobi City 00200
KenyaSite Not Available
PHRD KEMRI (Partners in Health Research & Development) ( Site 8651)
Nairobi, Nairobi City 00202
KenyaSite Not Available
KEMRI-CMR-RCTP ( Site 8650)
Kisumu, 40100
KenyaSite Not Available
Hospital Sultanah Bahiyah ( Site 7776)
Alor Setar, Kedah 05460
MalaysiaSite Not Available
University Malaya Medical Centre-Clinical Investigation Centre (CIC) ( Site 7777)
Lembah Pantai, Kuala Lumpur 59100
MalaysiaSite Not Available
Hospital Pulau Pinang ( Site 7779)
George Town, Pulau Pinang 10450
MalaysiaSite Not Available
Sarawak General Hospital ( Site 7772)
Kuching, Sarawak 93586
MalaysiaSite Not Available
Hospital Selayang ( Site 7770)
Batu Caves, Selangor 68100
MalaysiaSite Not Available
Hospital Sungai Buloh ( Site 7778)
Sungai Buloh, Selangor 47000
MalaysiaSite Not Available
Hospital Kuala Lumpur ( Site 7773)
Kuala Lumpur, 50586
MalaysiaSite Not Available
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 7251)
Mexico City, Distrito Federal 14080
MexicoSite Not Available
Ponce Medical School Foundation Inc. ( Site 7452)
Ponce, 00716
Puerto RicoSite Not Available
Clinical Research Puerto Rico ( Site 7450)
San Juan, 00909
Puerto RicoSite Not Available
HOPE Clinical Research ( Site 7451)
San Juan, 00909
Puerto RicoSite Not Available
Josha Research ( Site 6652)
Bloemfontein, Free State 9301
South AfricaSite Not Available
Ezintsha-Clinical Research Site ( Site 6656)
Johannesburg, Gauteng 2193
South AfricaSite Not Available
Helen Joseph Hospital-Clinical HIV Research Unit ( Site 6661)
Johannesburg, Gauteng 2092
South AfricaSite Not Available
Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 6654)
Johannesburg, Gauteng 2013
South AfricaSite Not Available
Wentworth Hospital ( Site 6653)
Durban, Kwazulu-Natal 4052
South AfricaSite Not Available
Qhakaza Mbokodo Research Clinic ( Site 6659)
Ladysmith, Kwazulu-Natal 3370
South AfricaSite Not Available
Human Sciences Research Council-Centre for Community Based Research ( Site 6664)
Pietermaritzburg, Kwazulu-Natal 3201
South AfricaSite Not Available
Madibeng Centre for Research ( Site 6660)
Brits, North-West 0250
South AfricaSite Not Available
Desmond Tutu Health Foundation ( Site 6651)
Cape Town, Western Cape 7925
South AfricaSite Not Available
Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6657)
Cape Town, Western Cape 7500
South AfricaSite Not Available
Be Part Yoluntu Centre ( Site 6650)
Paarl, Western Cape 7626
South AfricaSite Not Available
Hospital General Universitario de Elche-Infectius Disease ( Site 6358)
Elche, Alicante 03202
SpainSite Not Available
Hospital Germans Trias i Pujol-Fundació Lluita contra la Sida ( Site 6351)
Badalona, Barcelona 08916
SpainSite Not Available
HOSPITAL CLÍNIC DE BARCELONA-Infection Day Hospital ( Site 6350)
Barcelona, Cataluna 08036
SpainSite Not Available
Hospital Universitari de Bellvitge ( Site 6360)
L'Hospitalet De Llobregat,Barcelona, Cataluna 08907
SpainSite Not Available
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Unidad de Enfermedades Infecciosas ( Site 6353)
Madrid, Madrid, Comunidad De 28007
SpainSite Not Available
Hospital Universitario Ramón y Cajal-ENFERMEDADES INFECCIOSAS ( Site 6361)
Madrid, Madrid, Comunidad De 28034
SpainSite Not Available
Hospital Universitari Vall d'Hebron-Infectious Diseases: HIV unit ( Site 6352)
Barcelona, 08035
SpainSite Not Available
Hospital Universitario 12 de Octubre ( Site 6355)
Madrid, 28041
SpainSite Not Available
Hospital Universitario Fundación Jiménez Díaz-Internal Medicine. Infectious disease ( Site 6357)
Madrid, 28015
SpainSite Not Available
Hospital Universitario La Paz ( Site 6354)
Madrid, 28046
SpainSite Not Available
Hospital Universitario Virgen de la Victoria ( Site 6359)
Malaga, 29010
SpainSite Not Available
University Hospital Basel-Infectiology ( Site 8151)
Basel, Basel-Stadt 4031
SwitzerlandSite Not Available
Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 8150)
Genève, Geneve 1205
SwitzerlandSite Not Available
Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 7850)
Bangkok, Krung Thep Maha Nakhon 10700
ThailandSite Not Available
HIV Netherlands Australia Thailand Research Collaboration ( Site 7851)
Bangkok, Krung Thep Maha Nakhon 10330
ThailandSite Not Available
Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 7852
Chiang Mai, 50200
ThailandSite Not Available
Hacettepe Universite Hastaneleri ( Site 7650)
Altindağ, Ankara 06230
TurkeySite Not Available
Ankara Bilkent Şehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 7659)
Ankara, 06800
TurkeySite Not Available
Southmead Hospital ( Site 7952)
Bristol, Bristol, City Of BS10 5NB
United KingdomSite Not Available
Royal London Hospital ( Site 7951)
London, England E1 1BB
United KingdomSite Not Available
The Hathersage Centre ( Site 7953)
Manchester, England M13 0FH
United KingdomSite Not Available
King's College Hospital ( Site 7950)
London, London, City Of SE5 9RL
United KingdomSite Not Available
The Mortimer Market Centre for Sexual Health and HIV Research ( Site 7954)
London, London, City Of WC1E 6JB
United KingdomSite Not Available
Pueblo Family Physicians ( Site 5674)
Phoenix, Arizona 85015
United StatesSite Not Available
Pacific Oaks Medical Group ( Site 5681)
Beverly Hills, California 90211
United StatesSite Not Available
Ruane Clinical Research Group, Inc ( Site 5658)
Los Angeles, California 90036
United StatesSite Not Available
Vivent Health ( Site 5694)
Denver, Colorado 80246
United StatesSite Not Available
Washington Health Institute ( Site 5689)
Washington, District of Columbia 20017
United StatesSite Not Available
Midway Immunology and Research Center ( Site 5657)
Fort Pierce, Florida 34982
United StatesSite Not Available
AHF The Kinder Medical Group ( Site 5672)
Miami, Florida 33133
United StatesSite Not Available
AHF South Beach ( Site 5663)
Miami Beach, Florida 33140
United StatesSite Not Available
Orlando Immunology Center ( Site 5654)
Orlando, Florida 32803
United StatesSite Not Available
CAN Community Health - Sarasota ( Site 5668)
Sarasota, Florida 34237
United StatesSite Not Available
Triple O Research Institute, P.A ( Site 5666)
West Palm Beach, Florida 33407
United StatesSite Not Available
Atlanta I.D. Group ( Site 5680)
Atlanta, Georgia 30309
United StatesSite Not Available
Emory University Hospital Midtown Infectious Disease Clinic ( Site 5673)
Atlanta, Georgia 30308
United StatesSite Not Available
Emory University and Grady Health System-Medicine ( Site 5690)
Atlanta, Georgia 30308
United StatesSite Not Available
Infectious Disease Specialists of Atlanta ( Site 5653)
Decatur, Georgia 30033
United StatesActive - Recruiting
Metro Infectious Diseases Consultants L.L.C. ( Site 5653)
Decatur, Georgia 30033
United StatesSite Not Available
Mercer University, Department of Internal Medicine ( Site 5655)
Macon, Georgia 31201
United StatesSite Not Available
Howard Brown Health Center-Clinical Research ( Site 5665)
Chicago, Illinois 60613
United StatesSite Not Available
Rush University Medical Center-Infectious Disease ( Site 5671)
Chicago, Illinois 60612
United StatesSite Not Available
University of Illinois at Chicago-Project WISH ( Site 5685)
Chicago, Illinois 60612
United StatesSite Not Available
Be Well Medical Center ( Site 5650)
Berkley, Michigan 48072
United StatesSite Not Available
Henry Ford Hospital ( Site 5667)
Detroit, Michigan 48202
United StatesSite Not Available
KC CARE Health Center-Clinical Trials ( Site 5670)
Kansas City, Missouri 64111
United StatesSite Not Available
Jubilee Clinical Research ( Site 5679)
Las Vegas, Nevada 89106
United StatesSite Not Available
Las Vegas Research Center ( Site 5691)
Las Vegas, Nevada 89106
United StatesSite Not Available
ID Care ( Site 5676)
Hillsborough, New Jersey 08844
United StatesSite Not Available
Saint Michael's Medical Center ( Site 5682)
Newark, New Jersey 07102
United StatesSite Not Available
Jacobi Medical Center ( Site 5683)
Bronx, New York 10461
United StatesSite Not Available
Columbia University Irving Medical Center-Division of Infectious Diseases ( Site 5688)
New York, New York 10032
United StatesSite Not Available
Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 5675)
Charlotte, North Carolina 28204
United StatesSite Not Available
Regional Center for Infectious Diseases ( Site 5687)
Greensboro, North Carolina 27401
United StatesSite Not Available
University of Cincinnati Medical Center-Infectious Diseases - Outpatient ( Site 5662)
Cincinnati, Ohio 45267-0405
United StatesSite Not Available
Central Texas Clinical Research ( Site 5661)
Austin, Texas 78705
United StatesSite Not Available
St Hope Foundation ( Site 5659)
Bellaire, Texas 77401
United StatesSite Not Available
North Texas Infectious Diseases Consultants, P.A ( Site 5651)
Dallas, Texas 75246
United StatesSite Not Available
Prism Health North Texas, Oak Cliff Health Center ( Site 5660)
Dallas, Texas 75208
United StatesSite Not Available
AXCES Research - Texas - El Paso ( Site 5692)
El Paso, Texas 79902
United StatesSite Not Available
Texas Centers for Infectious Disease Associates ( Site 5656)
Fort Worth, Texas 76104
United StatesSite Not Available
DCOL Center for Clinical Research ( Site 5664)
Longview, Texas 75605
United StatesSite Not Available
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