Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants

PHASE3CompletedINTERVENTIONAL
Enrollment

1,149

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

February 28, 2017

Study Completion Date

October 31, 2020

Conditions
Human Immunodeficiency Virus Type 1
Interventions
DRUG

D/C/F/TAF

Once-daily single-tablet regimen containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg.

DRUG

Boosted Protease Inhibitor (bPI)

Boosted protease inhibitor (limited to darunavir \[DRV\] or atazanavir with low-dose ritonavir \[rtv\] or cobicistat \[COBI\], or lopinavir with rtv) as per current treatment regimen.

DRUG

FTC/TDF

Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).

Trial Locations (79)

Unknown

Phoenix

Bakersfield

Beverly Hills

Long Beach

Los Angeles

San Diego

San Francisco

Washington D.C.

Fort Lauderdale

Ft. Pierce

Orlando

West Palm Beach

Atlanta

Savannah

Chicago

Boston

Springfield

Berkley

Detroit

Minneapolis

Kansas City

St Louis

Hillsborough

Newark

Somers Point

Santa Fe

New York

Chapel Hill

Winston-Salem

Cincinnati

Philadelphia

Providence

Austin

Dallas

Fort Worth

Houston

Longview

Seattle

Antwerp

Brussels

Ghent

Leuven

Liège

Edmonton

Vancouver

Toronto

Montreal

Le Kremlin-Bicêtre

Lyon

Marseille

Montpellier

Nantes

Paris

Strasbourg

Tourcoing

Bydgoszcz

Chorzów

Lodz

Warsaw

Wroclaw

San Juan

Alicante

Badalona

Barcelona

Córdoba

Donostia / San Sebastian

Elche

Madrid

Seville

Valencia

Gothenburg

Malmo

Stockholm

Basel

Bern

Zurich

Brighton

London

Manchester

All Listed Sponsors
lead

Janssen R&D Ireland

INDUSTRY

NCT02269917 - Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants | Biotech Hunter | Biotech Hunter