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 Treatment-Naive People With HIV-1
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
The goal of this clinical study is to learn more about the experimental drugs GS-1720 (an oral, long-acting integrase strand transfer inhibitor (INSTI)) and GS-4182 (a prodrug of Lenacapavir (LEN)); to compare the combination of GS-1720 and GS-4182 with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy), 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 in treatment-naive people with HIV-1 (PWH). This study has two phases: Phase 2 and Phase 3. The primary objectives of this study are: Phase 2: To evaluate the efficacy of oral weekly GS-1720 coadministered with GS-4182 versus continuing Biktarvy (BVY) in treatment-naive PWH at Week 24. Phase 3: To evaluate the efficacy of oral weekly GS-1720/GS-4182 fixed-dose combination (FDC) tablet regimen versus continuing BVY in treatment-naive PWH at Week 48.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• HIV-1 RNA ≥ 500 copies/mL at screening.
• Antiretroviral (ARV) treatment-naive, except the use of oral pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or F/TAF, up to 1 month prior to screening.
Locations
United States
Alabama
UAB 1917 Research Clinic
RECRUITING
Birmingham
California
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
RECRUITING
Torrance
Mills Clinical Research
RECRUITING
West Hollywood
Washington, D.c.
Georgetown University Medical School
RECRUITING
Washington
Florida
Midland Florida Clinical Research Center, LLC
RECRUITING
Deland
Midway Immunology and Research Center
RECRUITING
Fort Pierce
Floridian Clinical Research, LLC
RECRUITING
Miami Lakes
Orlando Immunology Center
RECRUITING
Orlando
Triple O Research Institute, P.A.
RECRUITING
West Palm Beach
Georgia
Emory University Hospital Midtown Infectious Disease Clinic
RECRUITING
Atlanta
Mercer University, Department of Internal Medicine
RECRUITING
Macon
New Jersey
Saint Michael's Medical Center
RECRUITING
Newark
Texas
St Hope Foundation, Inc.
RECRUITING
Bellaire
North Texas Infectious Diseases Consultants, PA
RECRUITING
Dallas
Prism Health North Texas, Aids Arms
RECRUITING
Dallas
Texas Centers for Infectious Disease Associates
RECRUITING
Fort Worth
UT Health San Antonio
RECRUITING
San Antonio
Washington
MultiCare Rockwood Main Clinic
RECRUITING
Spokane
Other Locations
Canada
Clinique Médicale L'Actuel
RECRUITING
Montreal
Puerto Rico
HOPE Clinical Research
RECRUITING
San Juan
Proyecto ACTU
RECRUITING
San Juan
Contact Information
Primary
Gilead Clinical Study Information Center
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)
Time Frame
Start Date:2024-10-21
Estimated Completion Date:2030-08
Participants
Target number of participants:675
Treatments
Experimental: Phase 2: GS-1720 + GS-4182 (Treatment Group 1)
Participants will receive a 1-day loading dose of GS-1720 (1300 mg) and GS-4182 (600 mg) on Day 1.Thereafter, participants will take weekly doses of single agent GS-1720 (650 mg) and GS-4182 (300 mg) coadministered for at least 48 weeks.
Active_comparator: Phase 2: B/F/TAF (Treatment Group 2)
Participants will receive B/F/TAF (50/200/25 mg) daily for at least 48 weeks.
At the end of the randomized treatment, Phase 2 participants will be given the option to participate in the Extension Phase. Phase 2 Treatment Group 1 will switch to GS-1720/GS-4182 FDC (650/300 mg) weekly. Phase 2 Treatment Group 2 will receive a loading dose of GS-1720/GS-4182 FDC (1300 mg/600 mg) on Extension Phase Day 1, then GS-1720/GS-4182 FDC (650/300 mg) weekly. Participants who choose to enter the Extension Phase will receive GS-1720/GS-4182 FDC tablets until the product becomes available or until Gilead Sciences elects to discontinue the study, whichever occurs first.
Experimental: Phase 3: GS-1720/GS-4182 FDC + Placebo to Match (PTM) B/F/TAF (Treatment Group 1)
Participants will receive a 1-day loading dose of GS-1720/GS-4182 FDC on Day 1. Thereafter, participants will receive GS-1720/GS-4182 FDC tablets weekly + PTM B/F/TAF once daily. Participants will receive treatment for at least 96 weeks.
Participants will receive oral B/F/TAF daily along with PTM GS-1720/GS-4182 FDC weekly for at least 96 weeks. Additionally, participants will receive a 1-day loading dose of PTM GS-1720/GS-4182 on Day 1.
After the end of blinded treatment, Phase 3 participants will be given the option to participate in the Extension Phase. Phase 3 Treatment Group 1 will continue to receive GS-1720/GS-4182 FDC weekly while PTM B/F/TAF will be discontinued. Phase 3 Treatment Group 2 will switch to receive GS-1720/GS-4182 FDC tablets weekly. Participants in Treatment Group 2 will also receive a 1-day loading dose of GS-1720/GS-4182 FDC on Extension Phase Day 1.~Participants who choose to enter the Phase 3 Extension Phase will receive GS-1720/GS-4182 FDC tablets until the product becomes available or until Gilead Sciences elects to discontinue the study, whichever occurs first.