OVERVIEW
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
PROTOCOL 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.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
HIV-1-infection
Gender
N/A
Date
June 2026 - August 2027
Study Type
Interventional
Study Phase
Phase 2
Product
GS-3242 Tablet, GS-3242 Injection, Lenacapavir Tablet, Lenacapavir Injection, B/F/TAF
Eligibility information
Inclusion criteria
- Documented human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) < 50 copies/mL for ≥ 6 months before screening.
- Plasma HIV-1 RNA levels < 50 copies/mL at screening.
- Receiving bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®) (B/F/TAF) for ≥ 6 months prior to screening.
- No documented resistance to GS-3242 (integrase mutation Q148H/K/R plus at least 2 of the following integrase mutations: L74I/M, T97A, E138A/K/T, or G140A/C/S).
Exclusion criteria
- Prior use of, or exposure to GS-3242 or LEN.
- History of virologic failure while on an integrase strand transfer inhibitor (INSTI)-based regimen.
- Prior use of any long-acting parenteral antiretroviral therapy (ART) medications such as monoclonal antibodies or broadly neutralizing antibodies targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (36)
Pacific Oak Medical Group
Beverly Hills, California, United States, 90211
Optimus Medical Group
San Francisco, California, United States, 94102
University of California San Francisco, Community and Clinical Research Center
San Francisco, California, United States, 94110
Midland Florida Clinical Research Center, LLC
DeLand, Florida, United States, 32720
CAN Community Health Fort Lauderdale
Fort Lauderdale, Florida, United States, 33316
Midway Immunology and Research Center
Ft. Pierce, Florida, United States, 34982
AIDS Healthcare Foundation -Coconut Grove
Miami, Florida, United States, 33133
CAN Community Health Inc.
Sarasota, Florida, United States, 34237
Triple O Research Institute, PA
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
Southampton Community Healthcare
St Louis, Missouri, United States, 63139
South Jersey Infectious Disease
Somers Point, New Jersey, United States, 08244
AXCES Research Group, LLC
Santa Fe, New Mexico, United States, 87505
Brooklyn Clinical Research
Brooklyn, New York, United States, 11226
Rosedale Health and Wellness
Huntersville, North Carolina, United States, 28078
Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center
Philadelphia, Pennsylvania, United States, 19107
Central Texas Clinical Research
Austin, Texas, United States, 78705
North Texas Infectious Disease Consultants, P.A.
Dallas, Texas, United States, 75246
The Crofoot Research Center, INC.
Houston, Texas, United States, 77098
Diagnostic Clinic of Longview
Longview, Texas, United States, 75605
Clinical Alliance for Research& Education - Infectious Diseases, LLC(CARE-ID
Annandale, Virginia, United States, 22003
Taylor Square Private Clinic
Surry Hills, New South Wales, Australia, 2010
Momentum Clinical Research Darlinghurst
Sydney, New South Wales, Australia, 2010 NSW
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