NCT01815736

Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,443 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA \< 50 copies/mL at Week 48.

Conditions

• HIV
• HIV Infections

Interventions

Type	Name	Description
DRUG	E/C/F/TAF	150/150/200/10 mg FDC tablet administered orally once daily
DRUG	E/C/F/TDF	150/150/200/300 mg FDC tablet administered orally once daily
DRUG	EFV/FTC/TDF	600/200/300 mg FDC tablet administered orally once daily
DRUG	RTV	100 mg tablet administered orally once daily
DRUG	ATV	300 mg capsule administered orally once daily
DRUG	FTC/TDF	200/300 mg tablet administered orally once daily
DRUG	COBI	150 mg tablet administered orally once daily

Timeline

• Start date: 2013-03-27
• Primary completion: 2015-03-16
• Completion: 2020-04-01
• First posted: 2013-03-21
• Last updated: 2021-04-13
• Results posted: 2016-04-14

Locations

167 sites across 20 countries: United States, Australia, Austria, Belgium, Brazil, Canada, Denmark, Dominican Republic, France, Germany, Italy, Mexico, Netherlands, Portugal, Puerto Rico, Spain, Sweden, Switzerland, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study