Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

675

Participants

Timeline

Start Date

October 21, 2024

Primary Completion Date

January 31, 2029

Study Completion Date

August 31, 2030

Conditions
HIV-1-infection
Interventions
DRUG

GS-1720

Tablets administered orally without regard to food

DRUG

GS-4182

Tablets administered orally without regard to food

DRUG

Bictegravir/emtricitabine/tenofovir alafenamide

Tablets administered orally without regard to food

DRUG

GS-1720/GS-4182 FDC

Tablets administered orally without regard to food

DRUG

Placebo to Match BVY

Tablets administered orally without regard to food

DRUG

Placebo to Match GS1720/GS-4182 FDC

Tablets administered orally without regard to food

Trial Locations (57)

1401

CRISMO Research Center, Germiston

1632

The Aurum Institute Tembisa Clinic 4, Tembisa

2038

WITS RHI Research Centre, Johannesburg

4013

Durban International Clinical Research Site, Enhancing Care Foundation, Durban

4050

Unidade Local de Saúde de Santo António, E.P.E., Porto

4449

Clinical Research Institute of South Africa (CRISA), KwaZulu-Natal

5241

Synergy Biomed Research Institute, East London

5660

FPD Ndevana Community Research Site, Ndevana

8036

Hospital Clinic de Barcelona, Barcelona

9301

JOSHA Research, Bloemfontein

10016

NYU Langone Health Vaccine Center, New York

20007

Georgetown University Medical School, Washington D.C.

20146

ICH Study Center GmbH & Co. KG, Hamburg

28040

Hospital Clinico San Carlos, Madrid

29010

Hospital Universitario Virgen de la Victoria, Málaga

29425

Medical University of South Carolina (MUSC) Research Nexus, Charleston

30308

Emory University Hospital Midtown Infectious Disease Clinic, Atlanta

30625

Medizinische Hochschule Hannover, Klinik für Rheumatologie und Immunologie, Gebäude K14, Hanover

31201

Mercer University, Department of Internal Medicine, Macon

32720

Midland Florida Clinical Research Center, LLC, DeLand

32803

Orlando Immunology Center, Orlando

33016

Floridian Clinical Research, LLC, Miami Lakes

33407

Triple O Research Institute, P.A., West Palm Beach

34982

Midway Immunology and Research Center, Ft. Pierce

35222

UAB 1917 Research Clinic, Birmingham

36312

Hospital Universitario Alvaro Cunqueiro, Pontevedra

39216

University of Mississippi Medical Center, Jackson

45122

Universitätsmedizin Essen, Universitätsklinikum Essen, Klinik für Dermatologie, Venerologie und Allergologie, HPSTD-Ambulanz, Essen

46015

Hospital Arnau de Vilanova de Valencia, Valencia

53127

Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I, Immunologische Studienambulanz, Bonn

75208

Prism Health North Texas, Aids Arms, Dallas

75246

North Texas Infectious Diseases Consultants, PA, Dallas

76104

Texas Centers for Infectious Disease Associates, Fort Worth

77401

St Hope Foundation, Inc., Bellaire

78229

UT Health San Antonio, San Antonio

81675

Klinikum rechts der Isar, Technische Universität München, Klinik und Poliklinik für Innere Medizin II, München

90046

Mills Clinical Research, West Hollywood

90502

The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance

99202

MultiCare Rockwood Main Clinic, Spokane

400003

Spitalul Clinic De Boli Infectioase Cluj-Napoca, Cluj-Napoca

07102

Saint Michael's Medical Center, Newark

H2L 4P9

Clinique Médicale L'Actuel, Montreal

H4A 3J1

Chronic Viral Illness Service / McGill University Health Centre, Montreal

K1H 8L6

Ottawa Hospital Research Institute, Ottawa

85-030

Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza, Bydoszcz

80-172

Punkt Zdrowia, Gdansk

71-455

Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie, Szczecin

2720- 276

Unidade Local de Saude de Amadora Sinatra EPE, Hospital Prof. Doutor Fernando Fonseca, Amadora

1249-019

Unidade Local de Saúde de Lisboa Ocidental E.P.E. - Hospital Egas Moniz, Lisbon

1649-035

Unidade Local de Saúde de Santo Maria E.P.E. - Hospital Santa Maria, Lisbon

4200-319

Unidade Local de Saúde de São João E.P.E., Porto

00909

HOPE Clinical Research, San Juan

00935

Proyecto ACTU, San Juan

021105

Institutul National De Boli Infectioase Prof. Dr. Matei Bals, Bucharest

Unknown

Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu, Bucharest

Clinical Hospital of Infectious Diseases and Pneumophysiology Dr. Victor Babes Timisoara, Timișoara

00709

Spitalul Clinic de Boli Infectioase Constanta, Constanța

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT06613685 - Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated | Biotech Hunter | Biotech Hunter