Study of Oral Weekly GS-1720 and GS-4182 Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed
NCT Number: NCT06544733
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: HIV-1-Infection
Interventions: DRUG: GS-1720|DRUG: GS-4182|DRUG: Placebo to Match BVY|DRUG: Bictegravir/emtricitabine/tenofovir alafenamide|DRUG: GS-1720/GS-4182 FDC|DRUG: Placebo to Match GS1720/GS-4182 FDC
Sponsor: Gilead Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 675
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2029-06
Locations: Ruane Clinical Research Group, Los Angeles, California, 90036, United States|CAN Community Health, Fort Lauderdale, Florida, 33316, United States|Midway and Immunology Research Center, Fort Pierce, Florida, 34982, United States|CAN Community Health, Sarasota, Florida, 34237, United States|Prism Health North Texas, Oak Cliff Health Center, Dallas, Texas, 75215, United States|DCOL Center for Clinical Research, Longview, Texas, 75605, United States|Peter Shalit, MD, Seattle, Washington, 98104, United States|HOPE Clinical Research, San Juan, 00909, Puerto Rico

Summary:
The goal of this clinical study is to learn more about the experimental drugs GS-1720 and GS-4182; to compare the combination of GS-1720 and GS-4182 with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, BVY), 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.

This study has two phases: Phase 2 and Phase 3.

The primary objectives of this study are:

Phase 2: To evaluate the efficacy of switching to oral weekly GS-1720 in combination with GS-4182 versus continuing BVY in virologically suppressed people with HIV-1 (PWH) at Week 24.

Phase 3: To evaluate the efficacy of switching to oral weekly GS-1720/GS-4182 Fixed-dose combination (FDC) tablet regimen versus continuing BVY in virologically suppressed PWH at Week 48.

Primary Outcome Measures: Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by the United States (US) Food and Drug Administration (FDA)-defined Snapshot Algorithm, Week 24|Phase 3: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm, Week 48
Secondary Outcome Measures: Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm, Week 12|Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm, Week 48|Phase 2: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm, Week 12|Phase 2: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm, Week 24|Phase 2: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm, Week 48|Phase 2: Change From Baseline in Clusters of Differentiation 4 (CD4+) T-cell Count at Week 12, Baseline, Week 12|Phase 2: Change From Baseline in CD4+ T-cell Count at Week 24, Baseline, Week 24|Phase 2: Change From Baseline in CD4+ T-cell Count at Week 48, Baseline, Week 48|Phase 2: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) Through Week 12, First dose date up to Week 12|Phase 2: Percentage of Participants Experiencing TEAEs Through Week 24, First dose date up to Week 24|Phase 2: Percentage of Participants Experiencing TEAEs Through Week 48, First dose date up to Week 48|Phase 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 12, First dose date up to Week 12|Phase 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 24, First dose date up to Week 24|Phase 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 48, First dose date up to Week 48|Phase 2: Pharmacokinetic (PK) Parameter: Cmax of GS-1720 and Lenacapavir (LEN), Cmax is defined as the maximum observed concentration of drug., Day 1 up to Week 48|Phase 2: PK Parameter: Tmax of GS-1720 and LEN, Tmax is defined as the time (observed time point) of Cmax., Day 1 up to Week 48|Phase 2: PK Parameter: Ctau of GS-1720 and LEN, Ctau is defined as the observed drug concentration at the end of the dosing interval., Day 1 up to Week 48|Phase 2: PK Parameter: AUCtau of GS-1720 and LEN, AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval)., Day 1 up to Week 48|Phase 3: Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm, Week 96|Phase 3: Proportion of Participants With HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm, Week 48|Phase 3: Proportion of Participants With HIV-1 RNA < 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm, Week 96|Phase 3: Change From Baseline in CD4+ T-cell Count at Week 48, Baseline, Week 48|Phase 3: Change From Baseline in CD4+ T-cell Count at Week 96, Baseline, Week 96|Phase 3: Percentage of Participants Experiencing TEAEs Through Week 48, First dose date up to Week 48|Phase 3: Proportion of Participants Experiencing TEAEs Through Week 96, First dose date up to Week 96|Phase 3: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 48, First dose date up to Week 48|Phase 3: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 96, First dose date up to Week 96