Tenofovir Disoproxil Fumarate (Tenofovir DF) Versus Emtricitabine/Tenofovir DF in Subjects Resistant to Lamivudine

PHASE3CompletedINTERVENTIONAL
Enrollment

280

Participants

Timeline

Start Date

September 30, 2008

Primary Completion Date

November 30, 2011

Study Completion Date

February 28, 2015

Conditions
Hepatitis B
Interventions
DRUG

TDF

Tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg tablet administered orally once daily

DRUG

FTC/TDF

Emtricitabine (FTC)/TDF 200/300 mg fixed-dose combination tablet administered orally once daily

DRUG

TDF Placebo

TDF placebo tablet administered orally once daily

DRUG

FTC/TDF Placebo

FTC/TDF placebo tablet administered orally once daily

Trial Locations (69)

1126

Budapest

1407

Sofia

1527

Sofia

1606

Sofia

4032

Debrecen

4103

Seville

6035

Wellington

9010

Varna

11000

Belgrade

11355

Flushing

13353

Berlin

14021

Prague

16059

Bursa

18000

Niš

19107

Philadelphia

20099

Hamburg

21000

Novi Sad

25404

Pátrai

30625

Hanover

34000

Kragujevac

34205

Bradenton

34668

Üsküdar

35100

Izmir

40001

Ústí nad Labem

40225

Düsseldorf

41110

Larissa

45122

Essen

54642

Thessaloniki

55139

Samsun

60590

Frankfurt

61080

Trabzon

89081

Ulm

300736

Timișoara

400158

Cluj-Napoca

700111

Lasi

900708

Constanța

A-6020

Innsbruck

A-1090

Vienna

A-1130

Vienna

V5Z

Vancouver

V6AB46

Vancouver

V6Z 2K5

Vancouver

R3E 3P4

Winnepeg

M5G 1X5

Toronto

M5G 2C4

Toronto

M5T 2S8

Toronto

M6H 3M1

Toronto

625 00

Brno

304 60

Pilsen

160 00

Prague

Unknown

Stuttgart

Auckland

Hamilton

H5700

Gyula

H7400

Kasposvar

15-540

Bialystok

85-030

Bydgoszcz

41-500

Chorzów

31-351

Krakow

91-347

Lodz

71-455

Szczecin

01-201

Warsaw

02-507

Warsaw

50-220

Wroclaw

020125

Bucharest

021105

Bucharest

022328

Bucharest

030303

Bucharest

06100

Ankara

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT00737568 - Tenofovir Disoproxil Fumarate (Tenofovir DF) Versus Emtricitabine/Tenofovir DF in Subjects Resistant to Lamivudine | Biotech Hunter | Biotech Hunter