Phase
Condition
N/ATreatment
GS-4182
Placebo to Match GS1720/GS-4182 FDC
Placebo to Match BVY
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
HIV-1 RNA ≥ 500 copies/mL at screening.
Antiretroviral (ARV) treatment-naive, except the use of oral pre-exposureprophylaxis (PrEP) or postexposure prophylaxis (PEP) with emtricitabine/tenofovirdisoproxil fumarate (FTC/TDF) or F/TAF, up to 1 month prior to screening.
Exclusion
Key Exclusion Criteria:
Prior use of any long acting parenteral antiretrovirals (ARVs) such as monoclonalantibodies, broadly neutralizing antibodies targeting HIV-1, LEN, injectablecabotegravir (including oral cabotegravir lead-in), and/or injectable rilpivirine.
Documented resistance to the integrase strand-transfer inhibitor class,specifically, resistance-associated mutations E92G/Q, G118R, F121Y, Y143C/H/R,S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene.
Any of the following laboratory values at screening:
CD4 cell count < 200 cells/mm3 at screening.
Estimated glomerular filtrations arate < 60 mL/min according to theModification of Diet in Renal Disease formula.
Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase) > 1.5 × upper limit of normal (ULN).
Direct bilirubin > 1.5 × ULN.
Platelets count < 50,000 cells/mm3.
Hemoglobin < 8.0 g/dL.
Active or occult hepatitis B virus infection.
Active hepatitis C virus infection.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
Chronic Viral Illness Service / McGill University Health Centre
Montreal, H4A 3J1
CanadaSite Not Available
Clinique Médicale L'Actuel
Montreal, H2L 4P9
CanadaSite Not Available
Chronic Viral Illness Service / McGill University Health Centre
Montreal 6077243, H4A 3J1
CanadaSite Not Available
Clinique Médicale L'Actuel
Montreal 6077243, H2L 4P9
CanadaSite Not Available
Ottawa Hospital Research Institute
Ottawa, K1H 8L6
CanadaSite Not Available
Ottawa Hospital Research Institute
Ottawa 6094817, K1H 8L6
CanadaSite Not Available
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I, Immunologische Studienambulanz
Bonn, 53127
GermanySite Not Available
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I, Immunologische Studienambulanz
Bonn 2946447, 53127
GermanySite Not Available
Universitätsmedizin Essen, Universitätsklinikum Essen, Klinik für Dermatologie, Venerologie und Allergologie, HPSTD-Ambulanz
Essen, 45122
GermanySite Not Available
Universitätsmedizin Essen, Universitätsklinikum Essen, Klinik für Dermatologie, Venerologie und Allergologie, HPSTD-Ambulanz
Essen 2928810, 45122
GermanySite Not Available
ICH Study Center GmbH & Co. KG
Hamburg, 20146
GermanySite Not Available
ICH Study Center GmbH & Co. KG
Hamburg 2911298, 20146
GermanySite Not Available
Medizinische Hochschule Hannover, Klinik für Rheumatologie und Immunologie, Gebäude K14
Hannover, 30625
GermanySite Not Available
Medizinische Hochschule Hannover, Klinik für Rheumatologie und Immunologie, Gebäude K14
Hanover 2910831, 30625
GermanySite Not Available
Klinikum rechts der Isar, Technische Universität München, Klinik und Poliklinik für Innere Medizin II
Munchen, 81675
GermanySite Not Available
Klinikum rechts der Isar, Technische Universität München, Klinik und Poliklinik für Innere Medizin II
München 2867711, 81675
GermanySite Not Available
Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza
Bydoszcz, 85-030
PolandSite Not Available
Punkt Zdrowia
Gdansk, 80-172
PolandSite Not Available
Punkt Zdrowia
Gdansk 3099434, 80-172
PolandSite Not Available
Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie
Szczecin, 71-455
PolandSite Not Available
Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie
Szczecin 3083829, 71-455
PolandSite Not Available
Unidade Local de Saude de Amadora Sinatra EPE, Hospital Prof. Doutor Fernando Fonseca
Amadora, 2720- 276
PortugalSite Not Available
Unidade Local de Saude de Amadora Sinatra EPE, Hospital Prof. Doutor Fernando Fonseca
Amadora 2271772, 2720- 276
PortugalSite Not Available
Unidade Local de Saúde de Lisboa Ocidental E.P.E. - Hospital Egas Moniz
Lisboa, 1249-019
PortugalSite Not Available
Unidade Local de Saúde de Santo Maria E.P.E. - Hospital Santa Maria
Lisboa, 1649-035
PortugalSite Not Available
Unidade Local de Saúde de Lisboa Ocidental E.P.E. - Hospital Egas Moniz
Lisbon 2267057, 1249-019
PortugalSite Not Available
Unidade Local de Saúde de Santo Maria E.P.E. - Hospital Santa Maria
Lisbon 2267057, 1649-035
PortugalSite Not Available
Unidade Local de Saúde de Santo António, E.P.E.
Porto, 4050
PortugalSite Not Available
Unidade Local de Saúde de São João E.P.E.
Porto, 4200-319
PortugalSite Not Available
Unidade Local de Saúde de Santo António, E.P.E.
Porto 2735943, 4050
PortugalSite Not Available
Unidade Local de Saúde de São João E.P.E.
Porto 2735943, 4200-319
PortugalSite Not Available
HOPE Clinical Research
San Juan 4568127, PR 00909
Puerto RicoSite Not Available
Proyecto ACTU
San Juan 4568127, PR 00935
Puerto RicoSite Not Available
HOPE Clinical Research
San Juan, 00909
Puerto RicoSite Not Available
Proyecto ACTU
San Juan, 00935
Puerto RicoSite Not Available
Institutul National De Boli Infectioase Prof. Dr. Matei Bals
Bucharest, 021105
RomaniaSite Not Available
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu
Bucharest,
RomaniaSite Not Available
Institutul National De Boli Infectioase Prof. Dr. Matei Bals
Bucharest 683506, 021105
RomaniaSite Not Available
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu
Bucharest 683506,
RomaniaSite Not Available
Spitalul Clinic De Boli Infectioase Cluj-Napoca
Cluj-Napoca, 400003
RomaniaSite Not Available
Spitalul Clinic De Boli Infectioase Cluj-Napoca
Cluj-Napoca 681290, 400003
RomaniaSite Not Available
Spitalul Clinic de Boli Infectioase Constanta
Constanta, 00709
RomaniaSite Not Available
Spitalul Clinic de Boli Infectioase Constanta
Constanța 680963, 00709
RomaniaSite Not Available
Clinical Hospital of Infectious Diseases and Pneumophysiology Dr. Victor Babes Timisoara
Timisoara,
RomaniaSite Not Available
Clinical Hospital of Infectious Diseases and Pneumophysiology Dr. Victor Babes Timisoara
Timișoara 665087,
RomaniaSite Not Available
JOSHA Research
Bloemfontein, 9301
South AfricaSite Not Available
JOSHA Research
Bloemfontein 1018725, 9301
South AfricaSite Not Available
Durban International Clinical Research Site, Enhancing Care Foundation
Durban, 4013
South AfricaSite Not Available
Durban International Clinical Research Site, Enhancing Care Foundation
Durban 1007311, 4013
South AfricaSite Not Available
FPD Ndevana Community Research Site
East London, 5217
South AfricaActive - Recruiting
Synergy Biomed Research Institute
East London, 5241
South AfricaSite Not Available
Synergy Biomed Research Institute
East London 1006984, 5241
South AfricaSite Not Available
CRISMO Research Center
Germiston, 1401
South AfricaSite Not Available
CRISMO Research Center
Germiston 1002108, 1401
South AfricaSite Not Available
WITS RHI Research Centre
Johannesburg, 2038
South AfricaSite Not Available
WITS RHI Research Centre
Johannesburg 993800, 2038
South AfricaSite Not Available
Clinical Research Institute of South Africa (CRISA)
KwaZulu-Natal, 4449
South AfricaSite Not Available
FPD Ndevana Community Research Site
Ndevana, 5660
South AfricaSite Not Available
FPD Ndevana Community Research Site
Ndevana 12718754, 5660
South AfricaSite Not Available
The Aurum Institute Tembisa Clinic 4
Tembisa, 1632
South AfricaSite Not Available
The Aurum Institute Tembisa Clinic 4
Tembisa 949879, 1632
South AfricaSite Not Available
Hospital Clinic de Barcelona
Barcelona, 8036
SpainSite Not Available
Hospital Clinic de Barcelona
Barcelona 3128760, 8036
SpainSite Not Available
Hospital Clinico San Carlos
Madrid, 28040
SpainSite Not Available
Hospital Clinico San Carlos
Madrid 3117735, 28040
SpainSite Not Available
Hospital Universitario Fundación Jiménez Díaz
Madrid 3117735, 28040
SpainSite Not Available
Hospital Universitario Virgen de la Victoria
Malaga, 29010
SpainSite Not Available
Hospital Universitario Virgen de la Victoria
Málaga 2514256, 29010
SpainSite Not Available
Hospital Universitario Alvaro Cunqueiro
Pontevedra, 36312
SpainSite Not Available
Hospital Universitario Alvaro Cunqueiro
Pontevedra 3113209, 36312
SpainSite Not Available
Hospital Arnau de Vilanova de Valencia
Valencia, 46015
SpainSite Not Available
Hospital Arnau de Vilanova de Valencia
Valencia 2509954, 46015
SpainSite Not Available
UAB 1917 Research Clinic
Birmingham, Alabama 35222
United StatesSite Not Available
UAB 1917 Research Clinic
Birmingham 4049979, Alabama 4829764 35222
United StatesSite Not Available
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California 90502
United StatesSite Not Available
Mills Clinical Research
West Hollywood, California 90046
United StatesSite Not Available
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance 5403022, California 5332921 90502
United StatesSite Not Available
Mills Clinical Research
West Hollywood 5408076, California 5332921 90046
United StatesSite Not Available
Georgetown University Medical School
Washington, District of Columbia 20007
United StatesSite Not Available
Georgetown University Medical School
Washington D.C. 4140963, District of Columbia 4138106 20007
United StatesSite Not Available
Midland Florida Clinical Research Center, LLC
DeLand, Florida 32720
United StatesSite Not Available
Midway Immunology and Research Center
Fort Pierce, Florida 34982
United StatesSite Not Available
Floridian Clinical Research, LLC
Miami Lakes, Florida 33016
United StatesSite Not Available
Orlando Immunology Center
Orlando, Florida 32803
United StatesSite Not Available
Triple O Research Institute, P.A.
West Palm Beach, Florida 33407
United StatesSite Not Available
Midland Florida Clinical Research Center, LLC
DeLand 4152890, Florida 4155751 32720
United StatesSite Not Available
Midway Immunology and Research Center
Ft. Pierce 4156018, Florida 4155751 34982
United StatesSite Not Available
Floridian Clinical Research, LLC
Miami Lakes 4164186, Florida 4155751 33016
United StatesSite Not Available
Orlando Immunology Center
Orlando 4167147, Florida 4155751 32803
United StatesSite Not Available
Triple O Research Institute, P.A.
West Palm Beach 4177887, Florida 4155751 33407
United StatesSite Not Available
Emory University Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia 30308
United StatesSite Not Available
Mercer University, Department of Internal Medicine
Macon, Georgia 31201
United StatesSite Not Available
Emory University Hospital Midtown Infectious Disease Clinic
Atlanta 4180439, Georgia 4197000 30308
United StatesSite Not Available
Mercer University, Department of Internal Medicine
Macon 4207400, Georgia 4197000 31201
United StatesSite Not Available
University of Mississippi Medical Center
Jackson, Mississippi 39216
United StatesSite Not Available
University of Mississippi Medical Center
Jackson 4431410, Mississippi 4436296 39216
United StatesSite Not Available
Saint Michael's Medical Center
Newark, New Jersey 07102
United StatesSite Not Available
Saint Michael's Medical Center
Newark 5101798, New Jersey 5101760 07102
United StatesSite Not Available
NYU Langone Health Vaccine Center
New York, New York 10016
United StatesSite Not Available
NYU Langone Health Vaccine Center
New York 5128581, New York 5128638 10016
United StatesSite Not Available
Medical University of South Carolina (MUSC) Research Nexus
Charleston, South Carolina 29425
United StatesSite Not Available
Medical University of South Carolina (MUSC) Research Nexus
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available
St Hope Foundation, Inc.
Bellaire, Texas 77401
United StatesSite Not Available
North Texas Infectious Diseases Consultants, PA
Dallas, Texas 75246
United StatesSite Not Available
Prism Health North Texas, Aids Arms
Dallas, Texas 75208
United StatesSite Not Available
Texas Centers for Infectious Disease Associates
Fort Worth, Texas 76104
United StatesSite Not Available
UT Health San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
St Hope Foundation, Inc.
Bellaire 4673353, Texas 4736286 77401
United StatesSite Not Available
North Texas Infectious Diseases Consultants, PA
Dallas 4684888, Texas 4736286 75246
United StatesSite Not Available
Prism Health North Texas, Aids Arms
Dallas 4684888, Texas 4736286 75208
United StatesSite Not Available
Texas Centers for Infectious Disease Associates
Fort Worth 4691930, Texas 4736286 76104
United StatesSite Not Available
UT Health San Antonio
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
MultiCare Rockwood Main Clinic
Spokane, Washington 99202
United StatesSite Not Available
MultiCare Rockwood Main Clinic
Spokane 5811696, Washington 5815135 99202
United StatesSite Not Available

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