Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV
← catalyst calendarSponsored by Gilead Sciences (industry) · GILD — their whole pipeline →. With Merck Sharp & Dohme LLC.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
142actual
Sites
44
Country
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 | 2021-10-05 | actual | When the study began enrolling |
| Primary completion | 2023-12-19 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2021-09-22 | actual | When this record first appeared on the registry |
| Results posted | 2025-01-14 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-02-04 | 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
- Drug: LEN — also filed as GS-6207
- Drug: B/F/TAF — also filed as Biktarvy®
- Drug: ISL/LEN FDC
Primary outcome
what the primary-completion date above is the date OFPercentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by the US Food and Drug Administration (FDA)-Defined Snapshot Algorithm
measured Week 24
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol: Protocol Amendment 6posted 2025-12-02 · 2.7 MB · Prot_002.pdf
Study Protocol: Protocol Amendment 5posted 2024-11-19 · 3.8 MB · Prot_003.pdf
Statistical Analysis Planposted 2024-07-31 · 1.6 MB · SAP_001.pdf
Publications
- PMID 41429026 — 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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