Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated
← catalyst calendarSponsored by Gilead Sciences (industry) · GILD — their whole pipeline →.
Phase
Phase 2/3
Status
Terminated
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
73actual
Sites
58
Countries
Canada, Germany, Poland +6
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
Why the sponsor stopped it
Sponsor decision to terminate study.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-10-21 | actual | When the study began enrolling |
| Primary completion | 2026-03-16 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-03-16 | actual | The whole study's end, after follow-up |
| First posted | 2024-09-26 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-15 | 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: Bictegravir/emtricitabine/tenofovir alafenamide — also filed as Biktarvy ®
- Drug: lepetegravir/lenacapavir pacfosacil FDC — also filed as GS-1720/GS-4182
- Drug: Placebo to Match BVY
- 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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