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Study of Oral Weekly GS-1720 and GS-4182 Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed
Sponsor: Gilead Sciences
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
675
Start Date
2024-08-20
Completion Date
2029-06
Last Updated
2026-01-05
Healthy Volunteers
No
Conditions
Interventions
GS-1720
Tablets administered orally without regard to food
GS-4182
Tablets administered orally without regard to food
Placebo to Match BVY
Tablets administered orally without regard to food
Bictegravir/emtricitabine/tenofovir alafenamide
Tablets administered orally without regard to food
GS-1720/GS-4182 FDC
Tablets administered orally without regard to food
Placebo to Match GS1720/GS-4182 FDC
Tablets administered orally without regard to food
Locations (39)
UAB 1917 Research Clinic
Birmingham, Alabama, United States
Pacific Oaks Medical Group
Beverly Hills, California, United States
Ruane Clinical Research Group
Los Angeles, California, United States
Mills Clinical Research
Los Angeles, California, United States
BIOS Clinical Research
Palm Springs, California, United States
UCSF Division of HIV, Infectious Diseases & Global Medicine
San Francisco, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Midland Florida Clinical Research Center, LLC
DeLand, Florida, United States
CAN Community Health
Fort Lauderdale, Florida, United States
Midway and Immunology Research Center
Ft. Pierce, Florida, United States
AIDS Healthcare Foundation - The Kinder Medical Group
Miami, Florida, United States
Floridian Clinical Research
Miami Lakes, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
CAN Community Health
Sarasota, Florida, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States
Metro Infectious Disease Consultants, P.L.L.C.
Decatur, Georgia, United States
Mercer University, Department of Internal Medicine
Macon, Georgia, United States
Chatham County Health Department
Savannah, Georgia, United States
Be Well Medical Center
Berkley, Michigan, United States
KC CARE Health Center
Kansas City, Missouri, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
AXCES Research Group, LLC
Santa Fe, New Mexico, United States
NewYork-Presbyterian Queens
Flushing, New York, United States
NYU Langone Health Vaccine Center
New York, New York, United States
Rosedale Health and Wellness
Huntersville, North Carolina, United States
Central Texas Clinical Research
Austin, Texas, United States
St Hope Foundation, Inc.
Bellaire, Texas, United States
Prism Health North Texas, Oak Cliff Health Center
Dallas, Texas, United States
North Texas Infectious Diseases Consultants, PA
Dallas, Texas, United States
AXCES Research Group, LLC
El Paso, Texas, United States
Texas Centers for Infectious Disease Associates
Fort Worth, Texas, United States
The Crofoot Research Center, INC.
Houston, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States
Peter Shalit, MD
Seattle, Washington, United States
Centro Ararat, Inc.
San Juan, PR, Puerto Rico
Clinical Research Puerto Rico
San Juan, PR, Puerto Rico
HOPE Clinical Research
San Juan, PR, Puerto Rico
Proyecto ACTC
San Juan, PR, Puerto Rico