CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,443 enrolled
Drug / intervention
E/C/F/TAF +6 moredrug
Likely dose
E/C/F/TAF 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01815736
NCT01815736Phase 3Completed
CompareCT.gov

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

Gilead Sciences·interventional·Posted Mar 21, 2013·Updated Apr 13, 2021

In Brief

A Phase 3 clinical trial evaluating E/C/F/TAF, E/C/F/TDF, and 5 other interventions for HIV and HIV Infections. Completed, enrolled 1,443 participants across 167 sites in 20 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV, HIV Infections
CountriesAustralia, Austria, Belgium, Brazil, Canada, Denmark, Dominican Republic, France, Germany, Italy, Mexico, Netherlands, Portugal, Puerto Rico, Spain, Sweden, Switzerland, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 21, 2013
Enrollment StartMar 27, 2013
Primary CompletionMar 16, 2015
Study CompletionApr 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 13.3 years ago

Interventions

E/C/F/TAFdrug

150/150/200/10 mg FDC tablet administered orally once daily

E/C/F/TDFdrug

150/150/200/300 mg FDC tablet administered orally once daily

EFV/FTC/TDFdrug

600/200/300 mg FDC tablet administered orally once daily

RTVdrug

100 mg tablet administered orally once daily

ATVdrug

300 mg capsule administered orally once daily

FTC/TDFdrug

200/300 mg tablet administered orally once daily

COBIdrug

150 mg tablet administered orally once daily