NCT00262522 - Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, When Coadministered With Nucleoside Reverse Transcriptase Inhibitors in Antiretroviral Naive Human Immunodeficiency Virus Type 1 Infected Subjects | Biotech Hunter

Enrollment

664

Participants

Timeline

Start Date

November 30, 2005

Primary Completion Date

July 31, 2008

Study Completion Date

July 31, 2008

Conditions

Human Immunodeficiency Virus Infections

Interventions

DRUG

lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)

LPV/r 800/200 mg once daily (QD) tablet + emtricitabine (FTC) 200 mg QD + tenofovir disoproxil fumarate (TDF) 300 mg QD

DRUG

lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)

LPV/r 800/200 mg QD soft gel capsule (SGC) + FTC 200 mg QD + TDF 300 mg QD (8 weeks) followed by LPV/r 800/200 mg QD Tablet + FTC 200 mg QD + TDF 300 mg QD

DRUG

lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)

LPV/r 400/100 mg twice daily (BID) tablet + FTC 200 mg QD + TDF 300 mg QD

DRUG

lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)

LPV/r 400/100 mg BID SGC + FTC 200 mg QD + TDF 300 mg QD (8 weeks) followed by LPV/r 400/100 mg BID Tablet + FTC 200 mg QD + TDF 300 mg QD

Trial Locations (129)

1011

Site Reference ID/Investigator# 243, Lausanne

1200

Site Reference ID/Investigator# 235, Brussels

1211

Site Reference ID/Investigator# 289, Geneva

2000

Site Reference ID/Investigator# 234, Antwerp

2010

Site Reference ID/Investigator# 244, Darlinghurst

3000

Site Reference ID/Investigator# 236, Leuven

3004

Site Reference ID/Investigator# 245, Melbourne

3141

Site Reference ID/Investigator# 246, South Yarra

4000

Site Reference ID/Investigator# 225, Liège

4031

Site Reference ID/Investigator# 288, Basel

8036

Site Reference ID/Investigator# 224, Barcelona

8907

Site Reference ID/Investigator# 218, Barcelona

9000

Site Reference ID/Investigator# 233, Ghent

9007

Site Reference ID/Investigator# 254, Sankt Gallen

10016

Site Reference ID/Investigator# 241, Taipei

10149

Site Reference ID/Investigator# 193, Turin

13353

Site Reference ID/Investigator# 265, Berlin

13616

Site Reference ID/Investigator# 286, Aix-en-Provence

14620

Site Reference ID/Investigator# 2450, Rochester

15006

Site Reference ID/Investigator# 221, A Coruña

15705

Site Reference ID/Investigator# 217, Santiago de Compostela

16132

Site Reference ID/Investigator# 195, Genoa

20037

Site Reference ID/Investigator# 875, Washington D.C.

20127

Site Reference ID/Investigator# 201, Milan

20146

Site Reference ID/Investigator# 273, Hamburg

20157

Site Reference ID/Investigator# 198, Milan

23666

Site Reference ID/Investigator# 1156, Hampton

25030

Site Reference ID/Investigator# 275, Besançon

25123

Site Reference ID/Investigator# 203, Brescia

27100

Site Reference ID/Investigator# 199, Pavia

28007

Site Reference ID/Investigator# 292, Madrid

28029

Site Reference ID/Investigator# 205, Madrid

28034

Site Reference ID/Investigator# 191, Madrid

28040

Site Reference ID/Investigator# 219, Madrid

28041

Site Reference ID/Investigator# 209, Madrid

28046

Site Reference ID/Investigator# 223, Madrid

28209

Site Reference ID/Investigator# 784, Charlotte

30159

Site Reference ID/Investigator# 263, Hanover

30309

Site Reference ID/Investigator# 848, Atlanta

31201

Site Reference ID/Investigator# 873, Macon

32803

Site Reference ID/Investigator# 1153, Orlando

Site Reference ID/Investigator# 827, Orlando

33136

Site Reference ID/Investigator# 874, Miami

33311

Site Reference ID/Investigator# 844, Fort Lauderdale

33317

Site Reference ID/Investigator# 783, Plantation

33462

Site Reference ID/Investigator# 870, Atlantis

33614

Site Reference ID/Investigator# 825, Tampa

34243

Site Reference ID/Investigator# 849, Sarasota

34295

Site Reference ID/Investigator# 278, Montpellier

34695

Site Reference ID/Investigator# 845, Safety Harbor

34952

Site Reference ID/Investigator# 877, Port Saint Lucie

35033

Site Reference ID/Investigator# 274, Rennes

39008

Site Reference ID/Investigator# 213, Santander

41013

Site Reference ID/Investigator# 220, Seville

46009

Site Reference ID/Investigator# 215, Valencia

48903

Site Reference ID/Investigator# 190, Barakaldo

50011

Site Reference ID/Investigator# 192, Florence

50931

Site Reference ID/Investigator# 271, Cologne

53127

Site Reference ID/Investigator# 268, Bonn

54511

Site Reference ID/Investigator# 282, Vandœuvre-lès-Nancy

54636

Site Reference ID/Investigator# 207, Thessaloniki

55404

Site Reference ID/Investigator# 1157, Minneapolis

60590

Site Reference ID/Investigator# 266, Frankfurt

60612

Site Reference ID/Investigator# 1154, Chicago

60613

Site Reference ID/Investigator# 824, Chicago

63108

Site Reference ID/Investigator# 871, St Louis

67214

Site Reference ID/Investigator# 792, Wichita

69288

Site Reference ID/Investigator# 256, Lyon

75012

Site Reference ID/Investigator# 257, Paris

75014

Site Reference ID/Investigator# 281, Paris

75208

Site Reference ID/Investigator# 1155, Dallas

75246

Site Reference ID/Investigator# 850, Dallas

75475

Site Reference ID/Investigator# 280, Paris

75877

Site Reference ID/Investigator# 279, Paris

75970

Site Reference ID/Investigator# 284, Paris

77004

Site Reference ID/Investigator# 843, Houston

85006

Site Reference ID/Investigator# 823, Phoenix

85012

Site Reference ID/Investigator# 846, Phoenix

90211

Site Reference ID/Investigator# 851, Beverly Hills

90813

Site Reference ID/Investigator# 826, Long Beach

92663

Site Reference ID/Investigator# 876, Newport Beach

92708

Site Reference ID/Investigator# 872, Fountain Valley

105275

Site Reference ID/Investigator# 186, Moscow

Site Reference ID/Investigator# 189, Moscow

190020

Site Reference ID/Investigator# 188, Saint Petersburg

308433

Site Reference ID/Investigator# 5163, Singapore

T2R 0X7

Site Reference ID/Investigator# 175, Calgary

L8N 3Z5

Site Reference ID/Investigator# 184, Hamilton

H2L 4P9

Site Reference ID/Investigator# 177, Montreal

H2L 5B1

Site Reference ID/Investigator# 176, Montreal

H2X 2P4

Site Reference ID/Investigator# 179, Montreal

K1H 8L6

Site Reference ID/Investigator# 181, Ottawa

K1N 6N5

Site Reference ID/Investigator# 173, Ottawa

G1V 4G2

Site Reference ID/Investigator# 178, Ste-Foy

M4N 3M5

Site Reference ID/Investigator# 180, Toronto

M5B 1L6

Site Reference ID/Investigator# 182, Toronto

M5G 2C4

Site Reference ID/Investigator# 174, Toronto

V6Z 2C7

Site Reference ID/Investigator# 183, Vancouver

V6Z 2T1

Site Reference ID/Investigator# 172, Vancouver

639 00

Site Reference ID/Investigator# 294, Brno

305 99

Site Reference ID/Investigator# 296, Pilsen

D-10243

Site Reference ID/Investigator# 270, Berlin

D-44791

Site Reference ID/Investigator# 262, Bochum

D-90762

Site Reference ID/Investigator# 264, Fürth

D-20099

Site Reference ID/Investigator# 267, Hamburg

115 26

Site Reference ID/Investigator# 211, Athens

Unknown

Site Reference ID/Investigator# 237, Dublin

Site Reference ID/Investigator# 249, Dublin

00149

Site Reference ID/Investigator# 200, Rome

00161

Site Reference ID/Investigator# 196, Rome

00184

Site Reference ID/Investigator# 194, Rome

8025 AB

Site Reference ID/Investigator# 290, Zwolle

41-500

Site Reference ID/Investigator# 298, Chorzów

01-201

Site Reference ID/Investigator# 299, Warsaw

51-149

Site Reference ID/Investigator# 297, Wroclaw

00717-1563

Site Reference ID/Investigator# 185, Ponce

00731

Site Reference ID/Investigator# 208, Ponce

00936-5067

Site Reference ID/Investigator# 206, San Juan

03010

Site Reference ID/Investigator# 210, Alicante

08035

Site Reference ID/Investigator# 214, Barcelona

08041

Site Reference ID/Investigator# 216, Barcelona

08916

Site Reference ID/Investigator# 222, Barcelona

B9 5SS

Site Reference ID/Investigator# 238, Birmingham

BN2 1ES

Site Reference ID/Investigator# 232, Brighton

N18 1QX

Site Reference ID/Investigator# 226, London

NW3 2QG

Site Reference ID/Investigator# 231, London

SW17 0QT

Site Reference ID/Investigator# 227, London

W2 1NY

Site Reference ID/Investigator# 228, London

M8 5RB

Site Reference ID/Investigator# 229, Manchester