Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1
← catalyst calendarNCT06532656 · readout ≤ 1,442 d
Sponsored by Gilead Sciences (industry) · GILD — their whole pipeline →.
Phase
Phase 2/3
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
75estimated
Sites
21
Countries
Argentina, Italy, South Africa +2
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 | 2024-11-20 | actual | When the study began enrolling |
| Primary completion | Jul 2030 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2030 | estimated | The whole study's end, after follow-up |
| First posted | 2024-08-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-04 | 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: Lenacapavir — also filed as GS-6207
- Drug: BIC/LEN FDC
Primary outcomes
what the primary-completion date above is the date OFPK Parameter: Cmax of BIC and LEN at Steady State
measured Day 1 up to Week 24, as appropriate
PK Parameter: AUCtau of BIC and LEN at Steady State
measured Day 1 up to Week 24, as appropriate
PK Parameter: Ctrough of BIC and LEN at Steady State
measured Day 1 up to Week 24, as appropriate
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) Through Week 24
measured First dose date up to Week 24
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 24
measured First dose date up to Week 24
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