The goal of this clinical study is to compare how effective a long-acting injectable treatment of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) versus (CAB) and rilpivirine (RPV) injections given every 8 weeks in adults with HIV-1 whose virus is well controlled on daily oral treatment, after 1 year (52 weeks) of the treatment. The primary objective of this study are to evaluate the efficacy of switching to the regimen of LEN, TAB, and ZAB versus switching to CAB and RPV in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
590
Administered subcutaneously
Administered orally
Administered intravenously (IV)
Administered IV
Administered intramuscular (IM)
Administered IM
Optimus Medical Group
San Francisco, California, United States
RECRUITINGMidland Florida Clinical Research Center, LLC
DeLand, Florida, United States
RECRUITINGCAN Community Health Fort Lauderdale
Fort Lauderdale, Florida, United States
RECRUITINGMidway Immunology and Research Center
Ft. Pierce, Florida, United States
RECRUITINGCAN Community Health Miami Gardens
Miami Gardens, Florida, United States
RECRUITINGBLISS Health Inc.
Orlando, Florida, United States
RECRUITINGMOORE Clinical Research, Inc d/b/a TrueBlue Clinical Research
Tampa, Florida, United States
RECRUITINGTriple O Research Institute, P.A.
West Palm Beach, Florida, United States
RECRUITINGAtlantic Clinical Research Institute
West Palm Beach, Florida, United States
RECRUITINGAtlanta ID Group, PC
Atlanta, Georgia, United States
RECRUITING...and 9 more locations
Proportion of Participants With HIV-1 ribonucleic acid (RNA) ≥ 50 Copies/mL at Week 52 as Defined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm.
Time frame: Week 52
Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 92 as Defined by the US FDA Snapshot Algorithm.
Time frame: Week 92
Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm
Time frame: Week 52
Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 92 as Determined by the US FDA Snapshot Algorithm.
Time frame: Week 92
Change From Baseline in clusters of differentiation 4 (CD4) (CD4)+ T-cell Counts at Week 52
Time frame: Baseline, Week 52
Change From Baseline in CD4+ T-cell Counts at Week 92
Time frame: Baseline, Week 92
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)
Time frame: Up to Week 92
Percentages of Participants Prematurely Discontinuing Their Study Treatment due to an AE
Time frame: Up to Week 92
Trough Concentrations for LEN, TAB, and ZAB at Week 26
Time frame: Week 26
Trough Concentrations for LEN, TAB, and ZAB at Week 52
Time frame: Week 52
Trough Concentrations for LEN, TAB, and ZAB at Week 104
Time frame: Week 104
Percentages of Participants With Antidrug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) of TAB
Time frame: Up to 92 Weeks
Percentages of Participants With of ADAs and NAbs of ZAB
Time frame: Up to 92 Weeks
Gilead Clinical Study Information Center
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