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

Last updated: April 11, 2025
Sponsor: Gilead Sciences
Overall Status: Active - Recruiting

Phase

2/3

Condition

N/A

Treatment

Placebo to Match GS1720/GS-4182 FDC

Placebo to Match BVY

GS-1720/GS-4182 FDC

Clinical Study ID

NCT06613685
GS-US-695-7156
2024-512505-66
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical study is to learn more about the experimental drugs GS-1720 (an oral, long-acting integrase strand transfer inhibitor (INSTI)) and GS-4182 (a prodrug of Lenacapavir (LEN)); to compare the combination of GS-1720 and GS-4182 with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy), to see if the combination of GS-1720 and GS-4182 is safe and if it works for treating human immunodeficiency virus type 1 (HIV-1) infection in treatment-naive people with HIV-1 (PWH).

This study has two phases: Phase 2 and Phase 3.

The primary objectives of this study are:

Phase 2: To evaluate the efficacy of oral weekly GS-1720 coadministered with GS-4182 versus continuing Biktarvy (BVY) in treatment-naive PWH at Week 24.

Phase 3: To evaluate the efficacy of oral weekly GS-1720/GS-4182 fixed-dose combination (FDC) tablet regimen versus continuing BVY in treatment-naive PWH at Week 48.

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:

  1. CD4 cell count < 200 cells/mm3 at screening.

  2. Estimated glomerular filtrations arate < 60 mL/min according to theModification of Diet in Renal Disease formula.

  3. Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase) > 1.5 × upper limit of normal (ULN).

  4. Direct bilirubin > 1.5 × ULN.

  5. Platelets count < 50,000 cells/mm3.

  6. 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

Total Participants: 675
Treatment Group(s): 6
Primary Treatment: Placebo to Match GS1720/GS-4182 FDC
Phase: 2/3
Study Start date:
October 21, 2024
Estimated Completion Date:
August 31, 2030

Connect with a study center

  • Clinique Médicale L'Actuel

    Montreal, H2L 4P9
    Canada

    Active - Recruiting

  • Ottawa Hospital Research Institute

    Ottawa, K1H 8L6
    Canada

    Active - Recruiting

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

    Bonn, 53127
    Germany

    Active - Recruiting

  • ICH Study Center GmbH & Co. KG

    Hamburg, 20146
    Germany

    Active - Recruiting

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

    Hannover, 30625
    Germany

    Active - Recruiting

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

    Munchen, 81675
    Germany

    Active - Recruiting

  • Punkt Zdrowia

    Gdansk, 80-172
    Poland

    Active - Recruiting

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

    Amadora, 2720- 276
    Portugal

    Active - Recruiting

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

    Lisboa, 1649-035
    Portugal

    Active - Recruiting

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

    Porto, 4050
    Portugal

    Active - Recruiting

  • Unidade Local de Saúde de São João E.P.E.

    Porto, 4200-319
    Portugal

    Active - Recruiting

  • HOPE Clinical Research

    San Juan, 00909
    Puerto Rico

    Active - Recruiting

  • Proyecto ACTU

    San Juan, 00935
    Puerto Rico

    Active - Recruiting

  • Institutul National De Boli Infectioase Prof. Dr. Matei Bals

    Bucharest, 021105
    Romania

    Active - Recruiting

  • Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu

    Bucharest,
    Romania

    Active - Recruiting

  • Spitalul Clinic De Boli Infectioase Cluj-Napoca

    Cluj-Napoca, 400003
    Romania

    Active - Recruiting

  • Spitalul Clinic de Boli Infectioase Constanta

    Constanta, 00709
    Romania

    Active - Recruiting

  • JOSHA Research

    Bloemfontein, 9301
    South Africa

    Active - Recruiting

  • FPD Ndevana Community Research Site

    East London, 5217
    South Africa

    Active - Recruiting

  • Synergy Biomed Research Institute

    East London, 5241
    South Africa

    Active - Recruiting

  • CRISMO Research Center

    Germiston, 1401
    South Africa

    Active - Recruiting

  • WITS RHI Research Centre

    Johannesburg, 2038
    South Africa

    Active - Recruiting

  • Clinical Research Institute of South Africa (CRISA)

    KwaZulu-Natal, 4449
    South Africa

    Active - Recruiting

  • The Aurum Institute Tembisa Clinic 4

    Tembisa, 1632
    South Africa

    Active - Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 8036
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Malaga, 29010
    Spain

    Active - Recruiting

  • Hospital Universitario Alvaro Cunqueiro

    Pontevedra, 36312
    Spain

    Active - Recruiting

  • Hospital Arnau de Vilanova de Valencia

    Valencia, 46015
    Spain

    Active - Recruiting

  • UAB 1917 Research Clinic

    Birmingham, Alabama 35222
    United States

    Active - Recruiting

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

    Torrance, California 90502
    United States

    Active - Recruiting

  • Mills Clinical Research

    West Hollywood, California 90046
    United States

    Active - Recruiting

  • Georgetown University Medical School

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • Midland Florida Clinical Research Center, LLC

    DeLand, Florida 32720
    United States

    Active - Recruiting

  • Midway Immunology and Research Center

    Fort Pierce, Florida 34982
    United States

    Active - Recruiting

  • Floridian Clinical Research, LLC

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

  • Orlando Immunology Center

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Triple O Research Institute, P.A.

    West Palm Beach, Florida 33407
    United States

    Active - Recruiting

  • Emory University Hospital Midtown Infectious Disease Clinic

    Atlanta, Georgia 30308
    United States

    Active - Recruiting

  • Mercer University, Department of Internal Medicine

    Macon, Georgia 31201
    United States

    Active - Recruiting

  • Saint Michael's Medical Center

    Newark, New Jersey 07102
    United States

    Active - Recruiting

  • NYU Langone Health Vaccine Center

    New York, New York 10016
    United States

    Active - Recruiting

  • Medical University of South Carolina (MUSC) Research Nexus

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • St Hope Foundation, Inc.

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • North Texas Infectious Diseases Consultants, PA

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • Prism Health North Texas, Aids Arms

    Dallas, Texas 75208
    United States

    Active - Recruiting

  • Texas Centers for Infectious Disease Associates

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • UT Health San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • MultiCare Rockwood Main Clinic

    Spokane, Washington 99202
    United States

    Active - Recruiting

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