Phase
Condition
N/ATreatment
Placebo to Match GS1720/GS-4182 FDC
Placebo to Match BVY
GS-1720/GS-4182 FDC
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
Clinique Médicale L'Actuel
Montreal, H2L 4P9
CanadaActive - Recruiting
Ottawa Hospital Research Institute
Ottawa, K1H 8L6
CanadaActive - Recruiting
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I, Immunologische Studienambulanz
Bonn, 53127
GermanyActive - Recruiting
ICH Study Center GmbH & Co. KG
Hamburg, 20146
GermanyActive - Recruiting
Medizinische Hochschule Hannover, Klinik für Rheumatologie und Immunologie, Gebäude K14
Hannover, 30625
GermanyActive - Recruiting
Klinikum rechts der Isar, Technische Universität München, Klinik und Poliklinik für Innere Medizin II
Munchen, 81675
GermanyActive - Recruiting
Punkt Zdrowia
Gdansk, 80-172
PolandActive - Recruiting
Unidade Local de Saude de Amadora Sinatra EPE, Hospital Prof. Doutor Fernando Fonseca
Amadora, 2720- 276
PortugalActive - Recruiting
Unidade Local de Saúde de Santo Maria E.P.E. - Hospital Santa Maria
Lisboa, 1649-035
PortugalActive - Recruiting
Unidade Local de Saúde de Santo António, E.P.E.
Porto, 4050
PortugalActive - Recruiting
Unidade Local de Saúde de São João E.P.E.
Porto, 4200-319
PortugalActive - Recruiting
HOPE Clinical Research
San Juan, 00909
Puerto RicoActive - Recruiting
Proyecto ACTU
San Juan, 00935
Puerto RicoActive - Recruiting
Institutul National De Boli Infectioase Prof. Dr. Matei Bals
Bucharest, 021105
RomaniaActive - Recruiting
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu
Bucharest,
RomaniaActive - Recruiting
Spitalul Clinic De Boli Infectioase Cluj-Napoca
Cluj-Napoca, 400003
RomaniaActive - Recruiting
Spitalul Clinic de Boli Infectioase Constanta
Constanta, 00709
RomaniaActive - Recruiting
JOSHA Research
Bloemfontein, 9301
South AfricaActive - Recruiting
FPD Ndevana Community Research Site
East London, 5217
South AfricaActive - Recruiting
Synergy Biomed Research Institute
East London, 5241
South AfricaActive - Recruiting
CRISMO Research Center
Germiston, 1401
South AfricaActive - Recruiting
WITS RHI Research Centre
Johannesburg, 2038
South AfricaActive - Recruiting
Clinical Research Institute of South Africa (CRISA)
KwaZulu-Natal, 4449
South AfricaActive - Recruiting
The Aurum Institute Tembisa Clinic 4
Tembisa, 1632
South AfricaActive - Recruiting
Hospital Clinic de Barcelona
Barcelona, 8036
SpainActive - Recruiting
Hospital Universitario Virgen de la Victoria
Malaga, 29010
SpainActive - Recruiting
Hospital Universitario Alvaro Cunqueiro
Pontevedra, 36312
SpainActive - Recruiting
Hospital Arnau de Vilanova de Valencia
Valencia, 46015
SpainActive - Recruiting
UAB 1917 Research Clinic
Birmingham, Alabama 35222
United StatesActive - Recruiting
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California 90502
United StatesActive - Recruiting
Mills Clinical Research
West Hollywood, California 90046
United StatesActive - Recruiting
Georgetown University Medical School
Washington, District of Columbia 20007
United StatesActive - Recruiting
Midland Florida Clinical Research Center, LLC
DeLand, Florida 32720
United StatesActive - Recruiting
Midway Immunology and Research Center
Fort Pierce, Florida 34982
United StatesActive - Recruiting
Floridian Clinical Research, LLC
Miami Lakes, Florida 33016
United StatesActive - Recruiting
Orlando Immunology Center
Orlando, Florida 32803
United StatesActive - Recruiting
Triple O Research Institute, P.A.
West Palm Beach, Florida 33407
United StatesActive - Recruiting
Emory University Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia 30308
United StatesActive - Recruiting
Mercer University, Department of Internal Medicine
Macon, Georgia 31201
United StatesActive - Recruiting
Saint Michael's Medical Center
Newark, New Jersey 07102
United StatesActive - Recruiting
NYU Langone Health Vaccine Center
New York, New York 10016
United StatesActive - Recruiting
Medical University of South Carolina (MUSC) Research Nexus
Charleston, South Carolina 29425
United StatesActive - Recruiting
St Hope Foundation, Inc.
Bellaire, Texas 77401
United StatesActive - Recruiting
North Texas Infectious Diseases Consultants, PA
Dallas, Texas 75246
United StatesActive - Recruiting
Prism Health North Texas, Aids Arms
Dallas, Texas 75208
United StatesActive - Recruiting
Texas Centers for Infectious Disease Associates
Fort Worth, Texas 76104
United StatesActive - Recruiting
UT Health San Antonio
San Antonio, Texas 78229
United StatesActive - Recruiting
MultiCare Rockwood Main Clinic
Spokane, Washington 99202
United StatesActive - Recruiting
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