A Phase 3, Open-Label Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects

Trial Profile

A Phase 3, Open-Label Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 20 May 2017

At a glance

  • Drugs Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide (Primary) ; Atazanavir; Cobicistat; Efavirenz/emtricitabine/tenofovir-disoproxil-fumarate; Elvitegravir/emtricitabine/tenofovir disoproxil fumarate/cobicistat; Emtricitabine/tenofovir disoproxil fumarate; Ritonavir
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms Study 109
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 20 May 2017 Results of post hoc analyses of predefined efficacy (HIV1 RNA<50c/mL), bone and renal safety markers and tolerability endpoints for subgroups (age less than 50 and more than or equal to 50 years), presented at the 2017 Annual Scientific Meeting of the American Geriatrics Society
    • 29 Mar 2017 Planned End Date changed from 1 Feb 2017 to 1 Jun 2017.
    • 16 Feb 2017 Results of pooled analysis of two phase III studies (109 and 112) assessing bone health (n=1117) presented at the 24th Conference on Retroviruses and Opportunistic Infections
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