Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen
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Phase
Phase 2/3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
689actual
Sites
94
Countries
Argentina, Australia, Canada +12
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 | 2022-08-16 | actual | When the study began enrolling |
| Primary completion | 2025-09-29 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2022-08-16 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-10 | 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: Bictegravir — also filed as GS-9883
- Drug: Lenacapavir — also filed as GS-6207
- Drug: BIC/LEN FDC
- Drug: Stable Baseline Regimen
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 US 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
Publications
- PMID 41763229 — linked by the registry
- PMID 41313173 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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