Study of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed
← catalyst calendarNCT06544733 · readout ≤ 530 d
Sponsored by Gilead Sciences (industry) · GILD — their whole pipeline →.
Phase
Phase 2/3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
675estimated
Sites
39
Countries
Puerto Rico, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-08-20 | actual | When the study began enrolling |
| Primary completion | Jan 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jun 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2024-08-09 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- HIV-1-Infection
Interventions
- Drug: Lepetegravir — also filed as GS-1720
- Drug: Lenacapavir pacfosacil — also filed as GS-4182
- Drug: Placebo to Match BVY
- Drug: Bictegravir/emtricitabine/tenofovir alafenamide — also filed as Biktarvy®
- Drug: Lepetegravir/Lenacapavir pacfosacil FDC — also filed as GS-1720/GS-4182 FDC
- Drug: Placebo to Match GS1720/GS-4182 FDC
Primary outcomes
what the primary-completion date above is the date OFPhase 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
measured 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
measured Week 48
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