Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

5,399

Participants

Timeline

Start Date

September 2, 2016

Primary Completion Date

January 31, 2019

Study Completion Date

September 30, 2027

Conditions
Pre-Exposure Prophylaxis of HIV-1 Infection
Interventions
DRUG

F/TAF

200/25 mg tablet administered orally once daily

DRUG

F/TDF

200/300 mg tablet administered orally once daily

DRUG

F/TAF Placebo

Tablet administered orally once daily

DRUG

F/TDF Placebo

Tablet administered orally once daily

Trial Locations (93)

8

Dublin

1090

Vienna

2100

Copenhagen

2650

Hvidovre

5000

Odense

6202

Nice

8051

Graz

8200

Aarhus N

10029

New York

10032

New York

10037

New York

10439

Berlin

10467

The Bronx

10777

Berlin

13006

Marseille

19107

Philadelphia

20009

Washington D.C.

20036

Washington D.C.

20127

Milan

28010

Madrid

28078

Huntersville

30308

Atlanta

30309

Atlanta

30312

Atlanta

31201

Macon

32504

Pensacola

32803

Orlando

33136

Miami

33308

Fort Lauderdale

33316

Fort Lauderdale

33407

West Palm Beach

34982

Ft. Pierce

36312

Vigo

44109

Cleveland

48072

Berkley

48202

Detroit

53226

Milwaukee

55415

Minneapolis

60596

Frankfurt

60612

Chicago

60613

Chicago

70119

New Orleans

75020

Paris

75208

Dallas

75246

Dallas

75475

Paris

77098

Houston

78705

Austin

80045

Aurora

80209

Denver

81675

Munich

87505

Santa Fe

89104

Las Vegas

90036

Los Angeles

90069

Los Angeles

90211

Beverly Hills

90502

Torrance

92103

San Diego

92663

Newport Beach

94102

San Francisco

94103

San Francisco

94118

San Francisco

94609

Oakland

95817

Sacramento

95825

Sacramento

98101

Seattle

98104

Seattle

06510

New Haven

02215

Boston

01105

Springfield

08244

Somers Point

27599-7215

Chapel Hill

V6Z 2T1

Vancouver

M5G 1K2

Toronto

H2l 4P9

Montreal

H2L5B1

Montreal

H2W 1T8

Montreal

D07 A8NN

Dublin

00149

Roma

Unknown

Amsterdam

08907

Badalona

08015

Barcelona

W1D 6AQ

Soho

E1 1BB

Whitechapel

EH3 9HA

Edinburgh

BN2 1ES

Brighton

B9 5SS

Birmingham

E9 6SR

London

SE18 4QH

London

SE5 9RJ

London

W2 1NY

London

WC1E 6JB

London

M13 0FH

Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY