A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects

PHASE3CompletedINTERVENTIONAL
Enrollment

725

Participants

Timeline

Start Date

July 6, 2015

Primary Completion Date

March 2, 2017

Study Completion Date

September 30, 2020

Conditions
Immunodeficiency Virus Type 1, Human
Interventions
DRUG

Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC

A tablet containing DRV 800 mg, COBI 150 mg, FTC 200 mg and TAF) 10 mg will be administered once daily.

DRUG

DRV/COBI FDC

A tablet containing DRV 800 mg and COBI 150 mg will be administered once daily.

DRUG

FTC/TDF FDC

A tablet containing FTC 200 mg and TDF 300 mg will be administered once daily.

DRUG

D/C/F/TAF FDC - Matching Placebo

Matching placebo of D/C/F/TAF FDC will be administered once daily.

DRUG

FTC/TDF FDC Matching Placebo

Matching placebo of FTC/TDF FDC will be administered once daily.

DRUG

DRV/COBI FDC Matching Placebo

Matching placebo of DRV/COBI FDC will be administered once daily.

Trial Locations (80)

Unknown

Birmingham

Phoenix

Bakersfield

Long Beach

Los Angeles

North Hollywood

San Francisco

Washington D.C.

Ft. Pierce

Miami

Orlando

West Palm Beach

Savannah

Boston

Springfield

Berkley

Minneapolis

St Louis

Hillsborough

Newark

Somers Point

Santa Fe

Manhasset

Chapel Hill

Winston-Salem

Cincinnati

Fort Worth

Houston

Seattle

Antwerp

Brussels

Ghent

Toronto

Montreal

Clamart

Le Kremlin-Bicêtre

Lyon

Marseille

Montpellier

Nantes

Paris

Strasbourg

Tourcoing

Berlin

Bonn

Cologne

Essen

Frankfurt

Freiburg im Breisgau

Hamburg

Hanover

München

Bydgoszcz

Chorzów

Krakow

Lodz

Szczecin

Warsaw

Wroclaw

San Juan

Krasnodar

Oryol

Saint Petersburg

Saratov

Smolensk

Tolyatti

Voronezh

Yekaterinburg

Alicante

Badalona

Barcelona

Córdoba

Elche

Madrid

Santiago de Compostela

Seville

Valencia

Brighton

Bristol

London

All Listed Sponsors
lead

Janssen Sciences Ireland UC

INDUSTRY

NCT02431247 - A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects | Biotech Hunter | Biotech Hunter