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STATUS Recruitment Complete

Study of Oral Weekly GS-1720 and GS-4182 Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed (WONDERS1)

LAST UPDATED

March 25 2025

Clinicaltrials.gov ID

NCT06544733

CTSID

2024-511054-50

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 Virologically Suppressed People With HIV-1 (WONDERS1)

PROTOCOL SUMMARY

The goal of this clinical study is to learn more about the experimental drugs GS-1720 and GS-4182; to compare the combination of GS-1720 and GS-4182 with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, BVY), 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. This study has two phases: Phase 2 and Phase 3. The primary objectives of this study are: Phase 2: To evaluate the efficacy of switching to oral weekly GS-1720 in combination with GS-4182 versus continuing BVY in virologically suppressed people with HIV-1 (PWH) at Week 24. Phase 3: To evaluate the efficacy of switching to oral weekly GS-1720/GS-4182 Fixed-dose combination (FDC) tablet regimen versus continuing BVY in virologically suppressed 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

August 2024 - January 2028

Study Type

INTERVENTIONAL

Study Phase

PHASE2, PHASE3

Product

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

Eligibility Information

Inclusion

Inclusion Criteria

  • Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 24 weeks before and at screening.
  • Receiving BVY for ≥ 24 weeks prior to screening.
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Exclusion

Exclusion Criteria

  • Prior use of, or exposure to LEN, GS-1720, or GS-4182.
  • History of virologic failure while on an integrase strand-transfer inhibitor (INSTI)-based regimen.
  • Documented integrase strand-transfer inhibitor (INSTI) resistance, specifically, resistance-associated mutations (RAMs) E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene.
  • Prior use of any long-acting (LA) parenteral antiretrovirals (ARV) such as monoclonal antibodies (mAbs) or broadly neutralizing antibodies (bNAbs) targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.
  • Any of the following laboratory values at screening:
  • Clusters of differentiation 4 (CD4) cell count < 200 cells/mm^3 at screening
  • Glomerular filtration rate < 60 mL/min according to the Modification of Diet in Renal Disease formula
  • Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 1.5 × upper limit of normal (ULN)
  • Direct bilirubin > 1.5 × ULN
  • Platelets count < 50,000 cells/mm^3
  • Hemoglobin < 8.0 g/dL
  • Active or occult hepatitis B virus (HBV) infection.
  • Active hepatitis C virus (HCV).
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Locations

Locations (39)
Other

UAB 1917 Research Clinic

Birmingham, Alabama, United States, 35294

Other

Pacific Oaks Medical Group

Beverly Hills, California, United States, 90211

Other

Ruane Clinical Research Group

Los Angeles, California, United States, 90036

Other

Mills Clinical Research

Los Angeles, California, United States, 90069

Other

BIOS Clinical Research

Palm Springs, California, United States, 92262

Other

UCSF Division of HIV, Infectious Diseases & Global Medicine

San Francisco, California, United States, 94110

Other

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, United States, 90502

Other

Georgetown University Medical Center

Washington, District of Columbia, United States, 20007

Other

Midland Florida Clinical Research Center, LLC

DeLand, Florida, United States, 32720

Other

CAN Community Health

Fort Lauderdale, Florida, United States, 33316

Other

Midway and Immunology Research Center

Fort Pierce, Florida, United States, 34982

Other

Floridian Clinical Research

Miami Lakes, Florida, United States, 33016

Other

AIDS Healthcare Foundation - The Kinder Medical Group

Miami, Florida, United States, 33133

Other

Orlando Immunology Center

Orlando, Florida, United States, 32803

Other

CAN Community Health

Sarasota, Florida, United States, 34237

Other

Triple O Research Institute, P.A.

West Palm Beach, Florida, United States, 33407

Other

Metro Infectious Disease Consultants, P.L.L.C.

Decatur, Georgia, United States, 30033

Other

Mercer University, Department of Internal Medicine

Macon, Georgia, United States, 31201

Other

Chatham County Health Department

Savannah, Georgia, United States, 31401

Other

Be Well Medical Center

Berkley, Michigan, United States, 48072

Other

KC CARE Health Center

Kansas City, Missouri, United States, 64111

Other

Saint Michael's Medical Center

Newark, New Jersey, United States, 07102

Other

AXCES Research Group, LLC

Santa Fe, New Mexico, United States, 87505

Other

NewYork-Presbyterian Queens

Flushing, New York, United States, 11355

Other

NYU Langone Health Vaccine Center

New York, New York, United States, 10016

Other

Rosedale Health and Wellness

Huntersville, North Carolina, United States, 28078

Other

Central Texas Clinical Research

Austin, Texas, United States, 78705

Other

St Hope Foundation, Inc.

Bellaire, Texas, United States, 77401

Other

Prism Health North Texas, Oak Cliff Health Center

Dallas, Texas, United States, 75215

Other

North Texas Infectious Diseases Consultants, PA

Dallas, Texas, United States, 75246

Other

AXCES Research Group, LLC

El Paso, Texas, United States, 79902

Other

Texas Centers for Infectious Disease Associates

Fort Worth, Texas, United States, 76104

Other

The Crofoot Research Center, INC.

Houston, Texas, United States, 77098

Other

DCOL Center for Clinical Research

Longview, Texas, United States, 75605

Other

Peter Shalit, MD

Seattle, Washington, United States, 98104

Other

Centro Ararat, Inc.

San Juan, Puerto Rico, 00717

Other

Clinical Research Puerto Rico

San Juan, Puerto Rico, 00909-1711

Other

HOPE Clinical Research

San Juan, Puerto Rico, 00909

Other

Proyecto ACTC

San Juan, Puerto Rico, 00935