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

This randomized, open-label, active-controlled study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-Containing Combination single tablet regimen (STR) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically-suppressed HIV-1 positive subjects as determined by having HIV-1 RNA < 50 copies/mL at Week 48 following the switch.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label Study to Evaluate Switching From a TDF-containing Combination Regimens to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-suppressed, HIV-1 Positive Subjects
Enrollment: 1439
Study Start Date: April 2013
Estimated Study Completion Date: February 2016
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Arms:
- Experimental: E/C/F/TAF switch
- Active Comparator: Maintain pre-existing regimen