Trial Profile

A Phase 1b, Open-label Study to Evaluate the PK, Safety and Efficacy of B/F/TAF in HIV-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 17 Jul 2024

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At a glance

26 Apr 2024 According to a Gilead Sciences media release, company announced the U.S. Food and Drug Administration (FDA) approved an updated label with additional data reinforcing the safety and efficacy profile of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to treat pregnant people with HIV-1 (PWH) with suppressed viral loads includes additional data from this study 5310.
14 Sep 2022 Status changed from active, no longer recruiting to completed.
24 Feb 2022 Planned End Date changed from 1 Feb 2023 to 1 Oct 2022.

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