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A Phase 2/3, Multicenter, Open-label, Multicohort, Two-Part Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co), Administered With Background Regimen (BR) in HIV-1 Infected, Treatment-Experienced, Virologically Suppressed Pediatric Subjects

Trial Profile

A Phase 2/3, Multicenter, Open-label, Multicohort, Two-Part Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co), Administered With Background Regimen (BR) in HIV-1 Infected, Treatment-Experienced, Virologically Suppressed Pediatric Subjects

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 08 Nov 2019

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At a glance

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

    • 31 Aug 2018 Biomarkers information updated
    • 16 Feb 2017 Results (n=22) from Part A portion of the study presented at the 24th Conference on Retroviruses and Opportunistic Infections.
    • 11 Feb 2016 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
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