Trial Profile

A Phase 2/3, Multicenter, Open-label, Multicohort Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected, Virologically Suppressed Pediatric Participants

Status: Active, no longer recruiting

Phase of Trial: Phase II/III

Latest Information Update: 01 Jul 2025

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At a glance

Drugs Atazanavir (Primary) ; Atazanavir/cobicistat (Primary) ; Cobicistat (Primary) ; Cobicistat/darunavir (Primary) ; Darunavir (Primary) ; Emtricitabine/tenofovir alafenamide (Primary) ; Lopinavir/ritonavir (Primary) ; Nucleoside reverse transcriptase inhibitors
Indications HIV-1 infections
Focus Adverse reactions; Pharmacokinetics
Sponsors Gilead Sciences

22 Jan 2025 Status changed from recruiting to active, no longer recruiting.
22 Feb 2023 Results (n=9) assessing the pharmacokinetics, safety and efficacy in virologically supressed children greater than equal to 3y weighing 14 to less than 25kg taking the once-daily low dose tablet of F/TAF (120/15mg) and cobicistat-boosted darunavir, presented at the 30th Conference on Retroviruses and Opportunistic Infections 2023.
09 Jan 2023 Planned number of patients changed from 100 to 130.

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