A Phase 2/3 interventional study of lepetegravir and lenacapavir pacfosacil in HIV-1-infection, sponsored by Gilead Sciences. Terminated at 58 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Gilead Sciences · Phase 2/3, Interventional, and Treatment
The goal of this clinical study is to learn more about the experimental drugs lepetegravir (formerly GS-1720) (an oral, long-acting integrase strand transfer inhibitor (INSTI)) and lenacapavir pacfosacil (formerly GS-4182) (a prodrug of Lenacapavir (LEN)); to compare the combination of lepetegravir and lenacapavir pacfosacil with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy), to see if the combination of lepetegravir and lenacapavir pacfosacil 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 lepetegravir coadministered with lenacapavir pacfosacil versus continuing Biktarvy (BVY) in treatment-naive PWH at Week 24.
Phase 3: To evaluate the efficacy of oral weekly lepetegravir/lenacapavir pacfosacil fixed-dose combination (FDC) tablet regimen versus continuing BVY in treatment-naive PWH at Week 48.
Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Any of the following laboratory values at screening:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Participants will receive a 1-day loading dose of lepetegravir (1300 mg) and lenacapavir pacfosacil (600 mg) on Day 1.Thereafter, participants will take weekly doses of single agent lepetegravir (650 mg) and lenacapavir pacfosacil (300 mg) coadministered for at least 48 weeks.
Drug: lepetegravir · Drug: lenacapavir pacfosacil
Participants will receive B/F/TAF (50/200/25 mg) daily for at least 48 weeks.
Drug: Bictegravir/emtricitabine/tenofovir alafenamide
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 lepetegravir/lenacapavir pacfosacil FDC (650/300 mg) weekly. Phase 2 Treatment Group 2 will receive a loading dose of lepetegravir/lenacapavir pacfosacil FDC (1300 mg/600 mg) on Extension Phase Day 1, then lepetegravir/lenacapavir pacfosacil FDC (650/300 mg) weekly. Participants who choose to enter the Extension Phase will receive lepetegravir/lenacapavir pacfosacil FDC tablets until the product becomes available or until Gilead Sciences elects to discontinue the study, whichever occurs first.
Drug: lepetegravir/lenacapavir pacfosacil FDC
Participants will receive a 1-day loading dose of lepetegravir/lenacapavir pacfosacil FDC on Day 1. Thereafter, participants will receive lepetegravir/lenacapavir pacfosacil FDC tablets weekly + placebo to match (PTM) B/F/TAF once daily. Participants will receive treatment for at least 96 weeks.
Drug: lepetegravir/lenacapavir pacfosacil FDC · Drug: Placebo to Match BVY
Participants will receive oral B/F/TAF daily along with PTM lepetegravir/lenacapavir pacfosacil FDC weekly for at least 96 weeks. Additionally, participants will receive a 1-day loading dose of PTM lepetegravir/lenacapavir pacfosacil on Day 1.
Drug: Bictegravir/emtricitabine/tenofovir alafenamide · Drug: Placebo to Match GS1720/GS-4182 FDC
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 lepetegravir/lenacapavir pacfosacil FDC weekly while PTM B/F/TAF will be discontinued. Phase 3 Treatment Group 2 will switch to receive lepetegravir/lenacapavir pacfosacil FDC tablets weekly. Participants in Treatment Group 2 will also receive a 1-day loading dose of lepetegravir/lenacapavir pacfosacil FDC on Extension Phase Day 1. Participants who choose to enter the Phase 3 Extension Phase will receive lepetegravir/lenacapavir pacfosacil FDC tablets until the product becomes available or until Gilead Sciences elects to discontinue the study, whichever occurs first.
Drug: lepetegravir/lenacapavir pacfosacil FDC
Tablets administered orally without regard to food
Also known as: GS-1720
Tablets administered orally without regard to food
Also known as: GS-4182
Tablets administered orally without regard to food
Also known as: Biktarvy ®
Tablets administered orally without regard to food
Also known as: GS-1720/GS-4182
Tablets administered orally without regard to food
Tablets administered orally without regard to food
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 48
Phase 2: Change From Baseline in log10 HIV-1 RNA at Week 12
Time frame: Baseline, Week 12
Phase 2: Change From Baseline in log10 HIV-1 RNA at Week 24
Time frame: Baseline, Week 24
Phase 2: Change From Baseline in log10 HIV-1 RNA at Week 48
Time frame: Baseline, Week 48
Phase 2: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 12
Time frame: Baseline, Week 12
Phase 2: Change From Baseline in CD4 Cell Count at Week 24
Time frame: Baseline, Week 24
Phase 2: Change From Baseline in CD4 Cell Count at Week 48
Time frame: Baseline, Week 48
Phase 2: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) Through Week 12
Time frame: First dose date up to Week 12
Phase 2: Percentage of Participants Experiencing TEAEs Through Week 24
Time frame: First dose date up to Week 24
Phase 2: Percentage of Participants Experiencing TEAEs Through Week 48
Time frame: First dose date up to Week 48
Phase 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 12
Time frame: First dose date up to Week 12
Phase 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 24
Time frame: First dose date up to Week 24
Phase 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 48
Time frame: First dose date up to Week 48
Phase 2: Pharmacokinetic (PK) Parameter: Cmax of Lepetegravir and Lenacapavir (LEN), as Applicable
Cmax is defined as the maximum observed concentration of drug.
Time frame: Day 1 up to Week 24
Phase 2: PK Parameter: Tmax of Lepetegravir and LEN, as Applicable
Tmax is defined as the time (observed time point) of Cmax.
Time frame: Day 1 up to Week 24
Phase 2: PK Parameter: Ctau of Lepetegravir and LEN, as Applicable
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Time frame: Day 1 up to Week 24
Phase 2: PK Parameter: AUCtau of Lepetegravir and LEN, as Applicable
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Time frame: Day 1 up to Week 24
Phase 3: Proportion of Participants With HIV-1 RNA < 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 96
Phase 3: Change From Baseline in log10 HIV-1 RNA at Week 48
Time frame: Baseline, Week 48
Phase 3: Change From Baseline in log10 HIV-1 RNA at Week 96
Time frame: Baseline, Week 96
Phase 3: Change From Baseline in CD4 Cell Count at Week 48
Time frame: Baseline, Week 48
Phase 3: Change From Baseline in CD4 Cell Count at Week 96
Time frame: Baseline, Week 96
Phase 3: Percentage of Participants Experiencing TEAEs Through Week 48
Time frame: First dose date up to Week 48
Phase 3: Percentage of Participants Experiencing TEAEs Through Week 96
Time frame: First dose date up to Week 96
Phase 3: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 48
Time frame: First dose date up to Week 48
Phase 3: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 96
Time frame: First dose date up to Week 96
Plan to share: No
This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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