A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children

Trial Profile

A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children

Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 16 Jun 2017

At a glance

  • Drugs Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide (Primary)
  • Indications HIV-1 infections
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 10 Jun 2017 Biomarkers information updated
    • 28 Apr 2017 Planned primary completion date changed from 1 Oct 2017 to 1 Jun 2018.
    • 16 Feb 2017 Results (n=23) reporting intensive pharmacokinetic data and follow up data through week 24 for cohort 2, presented at the 24th Conference on Retroviruses and Opportunistic Infections.
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