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A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1
Sponsor: Gilead Sciences
Summary
The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35. In Part B the goal of the study is to compare the effectiveness of switching to the study drugs, GS-3242 and LEN versus continuing B/F/TAF in Groups 4 and 3 at Week 26. The primary objective of part A is to evaluate the efficacy of switching to intramuscular (IM) GS-3242 plus IM LEN versus continuing on B/F/TAF PWH who are virologically suppressed in treatment Groups 1, 2, and 3 at Week 35 and Part B is to evaluate the efficacy of switching to IM GS-3242 plus IM LEN versus continuing on B/F/TAF in PWH who are virologically suppressed in Treatment Groups 4 and 3 at Week 26.
Official title: A Phase 2 Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
175
Start Date
2026-06-15
Completion Date
2033-04
Last Updated
2026-08-06
Healthy Volunteers
No
Conditions
Interventions
GS-3242 Tablet
Administered orally
GS-3242 Injection
Administered intramuscularly (IM)
Lenacapavir Tablet
Administered orally
Lenacapavir Injection
Administered IM
B/F/TAF
Administered orally
Locations (36)
Pacific Oak Medical Group
Beverly Hills, California, United States
Optimus Medical Group
San Francisco, California, United States
University of California San Francisco, Community and Clinical Research Center
San Francisco, California, United States
Midland Florida Clinical Research Center, LLC
DeLand, Florida, United States
CAN Community Health Fort Lauderdale
Fort Lauderdale, Florida, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
AIDS Healthcare Foundation -Coconut Grove
Miami, Florida, United States
AHF - Pensacola
Pensacola, Florida, United States
CAN Community Health Inc.
Sarasota, Florida, United States
Triple O Research Institute, PA
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
Southampton Community Healthcare
St Louis, Missouri, United States
ID care
Hillsborough, New Jersey, United States
South Jersey Infectious Disease
Somers Point, New Jersey, United States
AXCES Research Group, LLC
Santa Fe, New Mexico, United States
Brooklyn Clinical Research
Brooklyn, New York, United States
Rosedale Health and Wellness
Huntersville, North Carolina, United States
Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center
Philadelphia, Pennsylvania, United States
Central Texas Clinical Research
Austin, Texas, United States
St. Hope Foundation
Bellaire, Texas, United States
Prism Health North Texas
Dallas, Texas, United States
North Texas Infectious Disease Consultants, P.A.
Dallas, Texas, United States
The Crofoot Research Center, INC.
Houston, Texas, United States
Diagnostic Clinic of Longview
Longview, Texas, United States
Clinical Alliance for Research& Education - Infectious Diseases, LLC(CARE-ID
Annandale, Virginia, United States
TribalMed PLLC
Seattle, Washington, United States
Taylor Square Private Clinic
Surry Hills, New South Wales, Australia
Momentum Clinical Research Darlinghurst
Sydney, New South Wales, Australia
East Sydney Doctors
Sydney, New South Wales, Australia
Prahran Market Clinic,
South Yarra, Victoria, Australia
Spectrum Health
Vancouver, Canada
Clinical Research Puerto Rico
San Juan, PR, Puerto Rico