NCT02345226

Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Adults

A Phase 3b, Randomized, Double-Blind Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/ Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 881 (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 emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) as compared to continuing the non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen of efavirenz /FTC/tenofovir disoproxil fumarate (EFV/FTC/TDF) FDC in virologically-suppressed HIV-1 infected participants.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	FTC/RPV/TAF	200/25/25 mg FDC tablets administered orally once daily
DRUG	EFV/FTC/TDF Placebo	Tablets administered orally once daily
DRUG	EFV/FTC/TDF	600/200/300 mg FDC tablets administered orally once daily
DRUG	FTC/RPV/TAF Placebo	Tablets administered orally once daily

Timeline

• Start date: 2015-01-26
• Primary completion: 2016-06-29
• Completion: 2019-01-02
• First posted: 2015-01-26
• Last updated: 2020-01-02
• Results posted: 2017-10-19

Locations

117 sites across 9 countries: United States, Belgium, Canada, France, Germany, Puerto Rico, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study