NCT02607956 - Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults | Biotech Hunter

Enrollment

657

Participants

Timeline

Start Date

November 11, 2015

Primary Completion Date

May 12, 2017

Study Completion Date

July 5, 2021

Conditions

HIV-1 Infection

Interventions

DRUG

DTG

50 mg tablets administered orally, once daily

DRUG

F/TAF

200/25 mg tablets administered orally, once daily

DRUG

B/F/TAF

50/200/25 milligrams (mg) FDC tablets administered orally, once daily

DRUG

DTG Placebo

Tablets administered orally, once daily

DRUG

F/TAF Placebo

Tablets administered orally, once daily

DRUG

B/F/TAF Placebo

Tablets administered orally, once daily

Trial Locations (125)

2000

Antwerp

3004

Melbourne

3010

Alicante

3053

Carlton

3068

Prahran

3168

Clayton

3181

Prahran Market Clinic, Prahran

10011

New York

10103

Santo Domingo

10461

The Bronx

11030

Manhasset

12157

Berlin

12208

Albany

15212

Allegheny Health Network, Pittsburgh

19104

Philadelphia

19107

Philadelphia

20009

Washington D.C.

20036

Washington D.C.

20037

Washington D.C.

20127

Milan

20146

Hamburg

21215

Sinai Hospital of Baltimore, Baltimore

24127

Bergamo

27157

Winston-Salem

27401

Cone Health Regional Center for Infectious Disease, Greensboro

27514

Chapel Hill

28007

Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

Madrid

28046

Madrid

28078

Huntersville

28207

Charlotte

29010

Málaga

30033

Decatur

30308

Atlanta

30312

Atlanta

31201

Macon

31405

Savannah

32504

Pensacola

32720

DeLand

32803

Orlando

33133

Miami

33136

Miami

33139

Miami Beach

33306

Oakland Park

33316

Fort Lauderdale

33407

West Palm Beach

33614

Tampa

34295

Montpellier

34982

Ft. Pierce

36312

Vigo

40237

Düsseldorf

45122

Essen

45267

Cincinnati

46202

Indianapolis

48072

Berkley

48202

Detroit

50924

Uniklinik Köln, Cologne

59200

Tourcoing

59208

Tourcoing

60311

Frankfurt

60590

Frankfurt

60613

Chicago

60657

Chicago

63108

St Louis

63139

St Louis

64111

Kansas City

75202

Dallas

75215

AIDS Arms Inc, Dallas

75235

Dallas

75246

North Texas Infectious Diseases Consultants PA, Dallas

75605

Longview

76104

Fort Worth

77004

Houston

77098

Houston

77401

Bellaire

78705

Austin

80205

Denver

80335

München

85012

Phoenix

85025

Phoenix

90027

Los Angeles

90036

Los Angeles

90059

Los Angeles

90069

Los Angeles

90211

Beverly Hills

94102

Optimus Medical - ClinEdge - PPDS, San Francisco

94577

Kaiser Permanente, San Leandro

95817

Sacramento

95825

Sacramento

98104

Seattle

99204

Spokane

02129

Boston

02215

Boston

01105

Springfield

08844

Hillsborough

07102

Newark

10011-4121

New York

27858-4354

Greenville

29203-6840

Columbia

22003-7313

Annandale

2010 NSW

Sydney

B-9000

Ghent

H4A 3J1

McGill University Health Center, Montreal

K1H 8L6

Ottawa

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M5G 1K2

Toronto

M5G2N2

Toronto

R3A 1R9

Winnipeg

06200

CHU de Nice Archet I, Nice

Unknown

Roma

00909-1711

San Juan

00909

San Juan

08907

Badalona

B4 6DH

Birmingham

B9 5SS

Birmingham

E1 1BB.

London

NW3 2QG

London

SE19 3ST

London

SE5 9RJ

London

SW10 9NH

Chelsea and Westminster NHS Trust, London

SW17 0QT

St George's Healthcare NHS Trust, London

WC1E 6JB

London

M13 0FH

Manchester

M8 5RB

Manchester