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 Virologically Suppressed People With HIV-1

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.

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

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 Criteria

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

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.

Locations

Locations (36)

Ruane Clinical Research Group

Los Angeles, California, United States, 90036

Mills Clinical Research

Los Angeles, California, United States, 90069

BIOS Clinical Research

Palm Springs, California, United States, 92262

UCSF Division of HIV, Infectious Diseases & Global Medicine

San Francisco, California, United States, 94110

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, United States, 90502

Georgetown University Medical Center

Washington, District of Columbia, United States, 20007

Midland Florida Clinical Research Center, LLC

DeLand, Florida, United States, 32720

CAN Community Health

Fort Lauderdale, Florida, United States, 33316

Midway and Immunology Research Center

Fort Pierce, Florida, United States, 34982

Floridian Clinical Research

Miami Lakes, Florida, United States, 33016

AIDS Healthcare Foundation - The Kinder Medical Group

Miami, Florida, United States, 33133

Orlando Immunology Center

Orlando, Florida, United States, 32803

CAN Community Health

Sarasota, Florida, United States, 34237

Triple O Research Institute, P.A.

West Palm Beach, Florida, United States, 33407

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

Decatur, Georgia, United States, 30033

Mercer University, Department of Internal Medicine

Macon, Georgia, United States, 31201

Chatham County Health Department

Savannah, Georgia, United States, 31401

KC CARE Health Center

Kansas City, Missouri, United States, 64111

Saint Michael's Medical Center

Newark, New Jersey, United States, 07102

AXCES Research Group, LLC

Santa Fe, New Mexico, United States, 87505

NewYork-Presbyterian Queens

Flushing, New York, United States, 11355

NYU Langone Health Vaccine Center

New York, New York, United States, 10016

Rosedale Health and Wellness

Huntersville, North Carolina, United States, 28078

Central Texas Clinical Research

Austin, Texas, United States, 78705

St Hope Foundation, Inc.

Bellaire, Texas, United States, 77401

Prism Health North Texas, Oak Cliff Health Center

Dallas, Texas, United States, 75215

North Texas Infectious Diseases Consultants, PA

Dallas, Texas, United States, 75246

AXCES Research Group, LLC

El Paso, Texas, United States, 79902

Texas Centers for Infectious Disease Associates

Fort Worth, Texas, United States, 76104

The Crofoot Research Center, INC.

Houston, Texas, United States, 77098

DCOL Center for Clinical Research

Longview, Texas, United States, 75605

Peter Shalit, MD

Seattle, Washington, United States, 98104

Centro Ararat, Inc.

San Juan, Puerto Rico, 00717

Clinical Research Puerto Rico

San Juan, Puerto Rico, 00909-1711

HOPE Clinical Research

San Juan, Puerto Rico, 00909

Proyecto ACTC

San Juan, Puerto Rico, 00935

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

OVERVIEW

PROTOCOL SUMMARY

Participation Requirements

Eligibility Information

Inclusion Criteria

Exclusion Criteria

Locations

Locations (36)

Ruane Clinical Research Group

Mills Clinical Research

BIOS Clinical Research

UCSF Division of HIV, Infectious Diseases & Global Medicine

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Georgetown University Medical Center

Midland Florida Clinical Research Center, LLC

CAN Community Health

Midway and Immunology Research Center

Floridian Clinical Research

AIDS Healthcare Foundation - The Kinder Medical Group

Orlando Immunology Center

CAN Community Health

Triple O Research Institute, P.A.

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

Mercer University, Department of Internal Medicine

Chatham County Health Department

KC CARE Health Center

Saint Michael's Medical Center

AXCES Research Group, LLC

NewYork-Presbyterian Queens

NYU Langone Health Vaccine Center

Rosedale Health and Wellness

Central Texas Clinical Research

St Hope Foundation, Inc.

Prism Health North Texas, Oak Cliff Health Center

North Texas Infectious Diseases Consultants, PA

AXCES Research Group, LLC

Texas Centers for Infectious Disease Associates

The Crofoot Research Center, INC.

DCOL Center for Clinical Research

Peter Shalit, MD

Centro Ararat, Inc.

Clinical Research Puerto Rico

HOPE Clinical Research

Proyecto ACTC