Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children
← catalyst calendarNCT06749054 · readout ≤ 224 d
Sponsored by Gilead Sciences (industry) · GILD — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
12estimated
Sites
9
Countries
South Africa, 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 | 2025-03-26 | actual | When the study began enrolling |
| Primary completion | Mar 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Sep 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2024-12-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-24 | 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: Oral Lenacapavir — also filed as GS-6207, Sunlenca®
- Drug: Subcutaneous Lenacapavir — also filed as GS-6207, Sunlenca®
- Drug: Optimized Background Regimen (OBR)
Primary outcomes
what the primary-completion date above is the date OFPharmacokinetic (PK) Parameter: Ctrough, W26 of Lenacapavir (LEN)
measured Week 26
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 26
measured First dose date up to Week 26
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 26
measured First dose date up to Week 26
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