Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV
← catalyst calendarNCT07055451 · readout ≤ 590 d
Sponsored by Gilead Sciences (industry) · GILD — their whole pipeline →.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
16estimated
Sites
7
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 | 2025-08-12 | actual | When the study began enrolling |
| Primary completion | Mar 2028 | estimated | 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 | 2025-07-09 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-18 | 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
Intervention
- Drug: B/F/TAF
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants Experiencing Treatment-emergent Adverse Events (TEAs) Though Week 8 After Neonate Birth
measured First dose date up to 8 Weeks
Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 8 After Neonate Birth
measured First dose date up to 8 Weeks
Pharmacokinetic (PK) parameters for Bictegravir (BIC): AUCinf
measured Predose up to 72 hours postdose
PK parameters for BIC: AUClast
measured Predose up to 72 hours postdose
PK parameters for BIC: AUC0-24h
measured Predose up to 24 hours postdose
PK parameters for BIC: Cmax
measured Predose up to 72 hours postdose
PK parameters for BIC: Tmax
measured Predose up to 72 hours postdose
PK parameters for BIC: Cmin
measured Predose up to 72 hours postdose
PK parameters for BIC: C24h
measured At 24 hours postdose
PK parameters for BIC: t1/2
measured Predose up to 72 hours postdose
PK parameters for BIC: Apparent CL/F
measured Predose up to 72 hours postdose
PK parameters for BIC: Apparent Vz/F
measured Predose up to 72 hours postdose
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