A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1
Start Date
6/15/2026
Completion Date
4/1/2033
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
GS-3242 Tablet
GS-3242 Injection
Lenacapavir Tablet
Lenacapavir Injection
B/F/TAF
Conditions
Locations
Pueblo Family Physicians
Phoenix, Arizona 85015
United States
Pacific Oak Medical Group
Beverly Hills, California 90211
United States
Ruane Clinical Research Group Inc.
Los Angeles, California 90036
United States
Optimus Medical Group
San Francisco, California 94102
United States
University of California San Francisco, Community and Clinical Research Center
San Francisco, California 94110
United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California 90502
United States
Vivent Health
Denver, Colorado 80246
United States
Midland Florida Clinical Research Center, LLC
DeLand, Florida 32720
United States
CAN Community Health Fort Lauderdale
Fort Lauderdale, Florida 33316
United States
Midway Immunology and Research Center
Ft. Pierce, Florida 34982
United States
AIDS Healthcare Foundation -Coconut Grove
Miami, Florida 33133
United States
Floridian Clinical Research, LLC
Miami Lakes, Florida 33016
United States
Orlando Immunology Center, PA
Orlanda, Florida 32803
United States
AHF - Pensacola
Pensacola, Florida 32504
United States
CAN Community Health Inc.
Sarasota, Florida 34237
United States
Triple O Research Institute, PA
West Palm Beach, Florida 33407
United States
Emory University Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia 30308
United States
Metro Infectious Disease Consultants, P.L.L.C.
Decatur, Georgia 30033
United States
Mercer University, Department of Internal Medicine
Macon, Georgia 31201
United States
Chatham County Health Department
Savannah, Georgia 31401
United States
Be Well Medical Center
Berkeley, Michigan 48072
United States
KC CARE Health Center
Kansas City, Missouri 64111
United States
Southampton Community Healthcare
St Louis, Missouri 63139
United States
ID care
Hillsborough, New Jersey 08844
United States
Saint Michael's Medical Center
Newark, New Jersey 07102
United States
South Jersey Infectious Disease
Somers Point, New Jersey 08244
United States
AXCES Research Group, LLC
Sante Fe, New Mexico 87505
United States
Brooklyn Clinical Research
Brooklyn, New York 11226
United States
NewYork-Presbyterian Queens
Flushing, New York 11355
United States
NYU Langone Health Vaccine Center
New York, New York 10016
United States
Montefiore Medical Center
The Bronx, New York 10467
United States
Rosedale Health and Wellness
Huntersville, North Carolina 28078
United States
Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center
Philadelphia, Pennsylvania 19107
United States
Central Texas Clinical Research
Austin, Texas 78705
United States
St. Hope Foundation
Bellaire, Texas 77401
United States
Prism Health North Texas
Dallas, Texas 75208
United States
North Texas Infectious Disease Consultants, P.A.
Dallas, Texas 75246
United States
AXCES Research Group, LLC
El Paso, Texas 79902
United States
Texas Centers for Infectious Disease Associates
Fort Worth, Texas 76109
United States
The Crofoot Research Center, INC.
Houston, Texas 77098
United States
Diagnostic Clinic of Longview
Longview, Texas 75605
United States
AXCES Research Group, LLC
Salt Lake City, Utah 84102
United States
Clinical Alliance for Research& Education - Infectious Diseases, LLC(CARE-ID
Annandale, Virginia 22003
United States
TribalMed PLLC
Seattle, Washington 98104
United States
MultiCare-Deaconess Medical Office Building 2
Spokane, Washington 99202
United States
Taylor Square Private Clinic
Surry Hills, New South Wales 2010
Australia
Momentum Clinical Research Darlinghurst
Sydney, New South Wales 2010 NSW
Australia
East Sydney Doctors
Sydney, New South Wales 2010
Australia
Prahran Market Clinic,
South Yarra, Victoria 3141
Australia
McGill University Health Centre
Montreal, Quebec H4A 3J1
Canada
CMU du Quartier Latin
Montreal, H2L 5B1
Canada
Spectrum Health
Vancouver, V6Z2T1
Canada
Proyecto ACTU
Rio Piedras, PR 00925
Puerto Rico
Clinical Research Puerto Rico
San Juan, PR 00909
Puerto Rico
HOPE Clinical Research
San Juan, PR 00909
Puerto Rico