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STATUS Recruitment Complete

Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated (WONDERS2)

LAST UPDATED

June 05 2025

Clinicaltrials.gov ID

NCT06613685

OVERVIEW

An Operationally Seamless Phase 2/3, Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination With GS-4182 Versus Biktarvy in Treatment-Naive People With HIV-1 (WONDERS2)

PROTOCOL 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.

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Participation Requirements

Calendar

Age

18 Years +

Condition

Sex

ALL

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

HIV-1-infection

Gender

N/A

Date

October 2024 - January 2029

Study Type

INTERVENTIONAL

Study Phase

PHASE2, PHASE3

Product

GS-1720, GS-4182, Bictegravir/emtricitabine/tenofovir alafenamide, GS-1720/GS-4182 FDC, Placebo to Match BVY, Placebo to Match GS1720/GS-4182 FDC

Eligibility Information

Inclusion

Inclusion Criteria

  • HIV-1 RNA ≥ 500 copies/mL at screening.
  • Antiretroviral (ARV) treatment-naive, except the use of oral pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or F/TAF, up to 1 month prior to screening.
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Exclusion

Exclusion Criteria

  • Prior use of any long acting parenteral antiretrovirals (ARVs) such as monoclonal antibodies, broadly neutralizing antibodies targeting HIV-1, LEN, injectable cabotegravir (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 the Modification 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.
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Locations

Locations (57)
Other

UAB 1917 Research Clinic

Birmingham, Alabama, United States, 35222

Other

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

Torrance, California, United States, 90502

Other

Mills Clinical Research

West Hollywood, California, United States, 90046

Other

Georgetown University Medical School

Washington, District of Columbia, United States, 20007

Other

Midland Florida Clinical Research Center, LLC

DeLand, Florida, United States, 32720

Other

Midway Immunology and Research Center

Fort Pierce, Florida, United States, 34982

Other

Floridian Clinical Research, LLC

Miami Lakes, Florida, United States, 33016

Other

Orlando Immunology Center

Orlando, Florida, United States, 32803

Other

Triple O Research Institute, P.A.

West Palm Beach, Florida, United States, 33407

Other

Emory University Hospital Midtown Infectious Disease Clinic

Atlanta, Georgia, United States, 30308

Other

Mercer University, Department of Internal Medicine

Macon, Georgia, United States, 31201

Other

University of Mississippi Medical Center

Jackson, Mississippi, United States, 39216

Other

Saint Michael's Medical Center

Newark, New Jersey, United States, 07102

Other

NYU Langone Health Vaccine Center

New York, New York, United States, 10016

Other

Medical University of South Carolina (MUSC) Research Nexus

Charleston, South Carolina, United States, 29425

Other

St Hope Foundation, Inc.

Bellaire, Texas, United States, 77401

Other

Prism Health North Texas, Aids Arms

Dallas, Texas, United States, 75208

Other

North Texas Infectious Diseases Consultants, PA

Dallas, Texas, United States, 75246

Other

Texas Centers for Infectious Disease Associates

Fort Worth, Texas, United States, 76104

Other

UT Health San Antonio

San Antonio, Texas, United States, 78229

Other

MultiCare Rockwood Main Clinic

Spokane, Washington, United States, 99202

Other

Clinique Médicale L'Actuel

Montreal, Canada, H2L 4P9

Other

Chronic Viral Illness Service / McGill University Health Centre

Montreal, Canada, H4A 3J1

Other

Ottawa Hospital Research Institute

Ottawa, Canada, K1H 8L6

Other

Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I, Immunologische Studienambulanz

Bonn, Germany, 53127

Other

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

Essen, Germany, 45122

Other

ICH Study Center GmbH & Co. KG

Hamburg, Germany, 20146

Other

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

Hannover, Germany, 30625

Other

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

Munchen, Germany, 81675

Other

Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza

Bydoszcz, Poland, 85-030

Other

Punkt Zdrowia

Gdansk, Poland, 80-172

Other

Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie

Szczecin, Poland, 71-455

Other

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

Amadora, Portugal, 2720- 276

Other

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

Lisboa, Portugal, 1249-019

Other

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

Lisboa, Portugal, 1649-035

Other

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

Porto, Portugal, 4050

Other

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

Porto, Portugal, 4200-319

Other

HOPE Clinical Research

San Juan, Puerto Rico, 00909

Other

Proyecto ACTU

San Juan, Puerto Rico, 00935

Other

Institutul National De Boli Infectioase Prof. Dr. Matei Bals

Bucharest, Romania, 021105

Other

Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu

Bucharest, Romania

Other

Spitalul Clinic De Boli Infectioase Cluj-Napoca

Cluj-Napoca, Romania, 400003

Other

Spitalul Clinic de Boli Infectioase Constanta

Constanta, Romania, 00709

Other

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

Timisoara, Romania

Other

JOSHA Research

Bloemfontein, South Africa, 9301

Other

Durban International Clinical Research Site, Enhancing Care Foundation

Durban, South Africa, 4013

Other

Synergy Biomed Research Institute

East London, South Africa, 5241

Other

CRISMO Research Center

Germiston, South Africa, 1401

Other

WITS RHI Research Centre

Johannesburg, South Africa, 2038

Other

Clinical Research Institute of South Africa (CRISA)

KwaZulu-Natal, South Africa, 4449

Other

FPD Ndevana Community Research Site

Ndevana, South Africa, 5660

Other

The Aurum Institute Tembisa Clinic 4

Tembisa, South Africa, 1632

Other

Hospital Clinic de Barcelona

Barcelona, Spain, 8036

Other

Hospital Clinico San Carlos

Madrid, Spain, 28040

Other

Hospital Universitario Virgen de la Victoria

Malaga, Spain, 29010

Other

Hospital Universitario Alvaro Cunqueiro

Pontevedra, Spain, 36312

Other

Hospital Arnau de Vilanova de Valencia

Valencia, Spain, 46015