Study Details

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.

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

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 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.

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.

Locations

Locations (57)

UAB 1917 Research Clinic

Birmingham, Alabama, United States, 35222

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

Torrance, California, United States, 90502

Mills Clinical Research

West Hollywood, California, United States, 90046

Georgetown University Medical School

Washington, District of Columbia, United States, 20007

Midland Florida Clinical Research Center, LLC

DeLand, Florida, United States, 32720

Midway Immunology and Research Center

Fort Pierce, Florida, United States, 34982

Floridian Clinical Research, LLC

Miami Lakes, Florida, United States, 33016

Orlando Immunology Center

Orlando, Florida, United States, 32803

Triple O Research Institute, P.A.

West Palm Beach, Florida, United States, 33407

Emory University Hospital Midtown Infectious Disease Clinic

Atlanta, Georgia, United States, 30308

Mercer University, Department of Internal Medicine

Macon, Georgia, United States, 31201

University of Mississippi Medical Center

Jackson, Mississippi, United States, 39216

Saint Michael's Medical Center

Newark, New Jersey, United States, 07102

NYU Langone Health Vaccine Center

New York, New York, United States, 10016

Medical University of South Carolina (MUSC) Research Nexus

Charleston, South Carolina, United States, 29425

St Hope Foundation, Inc.

Bellaire, Texas, United States, 77401

Prism Health North Texas, Aids Arms

Dallas, Texas, United States, 75208

North Texas Infectious Diseases Consultants, PA

Dallas, Texas, United States, 75246

Texas Centers for Infectious Disease Associates

Fort Worth, Texas, United States, 76104

UT Health San Antonio

San Antonio, Texas, United States, 78229

MultiCare Rockwood Main Clinic

Spokane, Washington, United States, 99202

Clinique Médicale L'Actuel

Montreal, Canada, H2L 4P9

Chronic Viral Illness Service / McGill University Health Centre

Montreal, Canada, H4A 3J1

Ottawa Hospital Research Institute

Ottawa, Canada, K1H 8L6

Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I, Immunologische Studienambulanz

Bonn, Germany, 53127

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

Essen, Germany, 45122

ICH Study Center GmbH & Co. KG

Hamburg, Germany, 20146

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

Hannover, Germany, 30625

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

Munchen, Germany, 81675

Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza

Bydoszcz, Poland, 85-030

Punkt Zdrowia

Gdansk, Poland, 80-172

Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie

Szczecin, Poland, 71-455

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

Amadora, Portugal, 2720- 276

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

Lisboa, Portugal, 1249-019

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

Lisboa, Portugal, 1649-035

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

Porto, Portugal, 4050

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

Porto, Portugal, 4200-319

HOPE Clinical Research

San Juan, Puerto Rico, 00909

Proyecto ACTU

San Juan, Puerto Rico, 00935

Institutul National De Boli Infectioase Prof. Dr. Matei Bals

Bucharest, Romania, 021105

Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu

Bucharest, Romania

Spitalul Clinic De Boli Infectioase Cluj-Napoca

Cluj-Napoca, Romania, 400003

Spitalul Clinic de Boli Infectioase Constanta

Constanta, Romania, 00709

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

Timisoara, Romania

JOSHA Research

Bloemfontein, South Africa, 9301

Durban International Clinical Research Site, Enhancing Care Foundation

Durban, South Africa, 4013

Synergy Biomed Research Institute

East London, South Africa, 5241

CRISMO Research Center

Germiston, South Africa, 1401

WITS RHI Research Centre

Johannesburg, South Africa, 2038

Clinical Research Institute of South Africa (CRISA)

KwaZulu-Natal, South Africa, 4449

FPD Ndevana Community Research Site

Ndevana, South Africa, 5660

The Aurum Institute Tembisa Clinic 4

Tembisa, South Africa, 1632

Hospital Clinic de Barcelona

Barcelona, Spain, 8036

Hospital Clinico San Carlos

Madrid, Spain, 28040

Hospital Universitario Virgen de la Victoria

Malaga, Spain, 29010

Hospital Universitario Alvaro Cunqueiro

Pontevedra, Spain, 36312

Hospital Arnau de Vilanova de Valencia

Valencia, Spain, 46015

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