Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1
← catalyst calendarSponsored by Gilead Sciences (industry) · GILD — their whole pipeline →. With Merck Sharp & Dohme LLC.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
609actual
Sites
106
Countries
Argentina, Australia, Canada +9
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 | 2024-10-09 | actual | When the study began enrolling |
| Primary completion | 2026-04-17 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2030 | estimated | The whole study's end, after follow-up |
| First posted | 2024-10-08 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-30 | 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: ISL/LEN
- Drug: B/F/TAF — also filed as Biktarvy®
- Drug: PTM B/F/TAF
- Drug: PTM ISL/LEN
Primary outcome
what the primary-completion date above is the date OFProportion of Participants with HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the United States (US) Food and Drug Administration (FDA)-Defined Snapshot Algorithm
measured Week 48
Publications
- PMID 42525925 — 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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