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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

Primary Purpose

Human Immunodeficiency Virus Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus Infections focused on measuring Human Immunodeficiency Virus Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria Subjects were human immunodeficiency virus type 1 (HIV-1) positive, antiretroviral naïve adults at least 18 years of age with < 7 days of prior antiretroviral therapy. Subjects had plasma HIV-1 ribonucleic acid (RNA) levels >= 1,000 copies/mL at screening and were not acutely ill. Female subjects were nonpregnant and nonlactating. Exclusion Criteria Subjects were excluded if screening laboratory analyses showed any of the following abnormal laboratory results: Presence of hepatitis B surface antigen (HBsAg) Hemoglobin <= 8.0 g/dL Absolute neutrophil count <= 750 cells/microliter Platelet count <= 50,000 per mL Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 3.0 x Upper Limit of Normal (ULN) Calculated creatinine clearance < 50 mL/min

Sites / Locations

  • Site Reference ID/Investigator# 823
  • Site Reference ID/Investigator# 846
  • Site Reference ID/Investigator# 851
  • Site Reference ID/Investigator# 872
  • Site Reference ID/Investigator# 826
  • Site Reference ID/Investigator# 876
  • Site Reference ID/Investigator# 875
  • Site Reference ID/Investigator# 870
  • Site Reference ID/Investigator# 844
  • Site Reference ID/Investigator# 874
  • Site Reference ID/Investigator# 1153
  • Site Reference ID/Investigator# 827
  • Site Reference ID/Investigator# 783
  • Site Reference ID/Investigator# 877
  • Site Reference ID/Investigator# 845
  • Site Reference ID/Investigator# 849
  • Site Reference ID/Investigator# 825
  • Site Reference ID/Investigator# 848
  • Site Reference ID/Investigator# 873
  • Site Reference ID/Investigator# 1154
  • Site Reference ID/Investigator# 824
  • Site Reference ID/Investigator# 792
  • Site Reference ID/Investigator# 1157
  • Site Reference ID/Investigator# 871
  • Site Reference ID/Investigator# 2450
  • Site Reference ID/Investigator# 784
  • Site Reference ID/Investigator# 1155
  • Site Reference ID/Investigator# 850
  • Site Reference ID/Investigator# 843
  • Site Reference ID/Investigator# 1156
  • Site Reference ID/Investigator# 244
  • Site Reference ID/Investigator# 245
  • Site Reference ID/Investigator# 246
  • Site Reference ID/Investigator# 234
  • Site Reference ID/Investigator# 235
  • Site Reference ID/Investigator# 233
  • Site Reference ID/Investigator# 236
  • Site Reference ID/Investigator# 225
  • Site Reference ID/Investigator# 175
  • Site Reference ID/Investigator# 184
  • Site Reference ID/Investigator# 177
  • Site Reference ID/Investigator# 176
  • Site Reference ID/Investigator# 179
  • Site Reference ID/Investigator# 181
  • Site Reference ID/Investigator# 173
  • Site Reference ID/Investigator# 178
  • Site Reference ID/Investigator# 180
  • Site Reference ID/Investigator# 182
  • Site Reference ID/Investigator# 174
  • Site Reference ID/Investigator# 183
  • Site Reference ID/Investigator# 172
  • Site Reference ID/Investigator# 294
  • Site Reference ID/Investigator# 296
  • Site Reference ID/Investigator# 286
  • Site Reference ID/Investigator# 275
  • Site Reference ID/Investigator# 256
  • Site Reference ID/Investigator# 278
  • Site Reference ID/Investigator# 257
  • Site Reference ID/Investigator# 281
  • Site Reference ID/Investigator# 280
  • Site Reference ID/Investigator# 279
  • Site Reference ID/Investigator# 284
  • Site Reference ID/Investigator# 274
  • Site Reference ID/Investigator# 282
  • Site Reference ID/Investigator# 265
  • Site Reference ID/Investigator# 270
  • Site Reference ID/Investigator# 262
  • Site Reference ID/Investigator# 268
  • Site Reference ID/Investigator# 271
  • Site Reference ID/Investigator# 266
  • Site Reference ID/Investigator# 264
  • Site Reference ID/Investigator# 273
  • Site Reference ID/Investigator# 267
  • Site Reference ID/Investigator# 263
  • Site Reference ID/Investigator# 211
  • Site Reference ID/Investigator# 207
  • Site Reference ID/Investigator# 249
  • Site Reference ID/Investigator# 237
  • Site Reference ID/Investigator# 203
  • Site Reference ID/Investigator# 192
  • Site Reference ID/Investigator# 195
  • Site Reference ID/Investigator# 201
  • Site Reference ID/Investigator# 198
  • Site Reference ID/Investigator# 199
  • Site Reference ID/Investigator# 200
  • Site Reference ID/Investigator# 196
  • Site Reference ID/Investigator# 194
  • Site Reference ID/Investigator# 193
  • Site Reference ID/Investigator# 290
  • Site Reference ID/Investigator# 298
  • Site Reference ID/Investigator# 299
  • Site Reference ID/Investigator# 297
  • Site Reference ID/Investigator# 185
  • Site Reference ID/Investigator# 208
  • Site Reference ID/Investigator# 206
  • Site Reference ID/Investigator# 186
  • Site Reference ID/Investigator# 189
  • Site Reference ID/Investigator# 188
  • Site Reference ID/Investigator# 5163
  • Site Reference ID/Investigator# 221
  • Site Reference ID/Investigator# 210
  • Site Reference ID/Investigator# 190
  • Site Reference ID/Investigator# 214
  • Site Reference ID/Investigator# 216
  • Site Reference ID/Investigator# 222
  • Site Reference ID/Investigator# 224
  • Site Reference ID/Investigator# 218
  • Site Reference ID/Investigator# 292
  • Site Reference ID/Investigator# 205
  • Site Reference ID/Investigator# 191
  • Site Reference ID/Investigator# 219
  • Site Reference ID/Investigator# 209
  • Site Reference ID/Investigator# 223
  • Site Reference ID/Investigator# 213
  • Site Reference ID/Investigator# 217
  • Site Reference ID/Investigator# 220
  • Site Reference ID/Investigator# 215
  • Site Reference ID/Investigator# 288
  • Site Reference ID/Investigator# 289
  • Site Reference ID/Investigator# 243
  • Site Reference ID/Investigator# 254
  • Site Reference ID/Investigator# 241
  • Site Reference ID/Investigator# 238
  • Site Reference ID/Investigator# 232
  • Site Reference ID/Investigator# 226
  • Site Reference ID/Investigator# 231
  • Site Reference ID/Investigator# 227
  • Site Reference ID/Investigator# 228
  • Site Reference ID/Investigator# 229

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

LPV/r 800/200 mg QD Tablet

LPV/r 800/200 mg QD SGC (Through Week 8)

LPV/r 400/100 mg BID Tablet

LPV/r 400/100 mg BID SGC (Through Week 8)

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks
Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 48

Secondary Outcome Measures

Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 96
Mean Change From Baseline to Week 96 in CD4+ T Cell Counts

Full Information

First Posted
December 5, 2005
Last Updated
February 3, 2012
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00262522
Brief Title
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
Official Title
A Phase 3, Randomized, Open-label, Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, When Coadministered With NRTIs in Antiretroviral Naive HIV-1 Infected Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to compare the safety and tolerability of the to-be-marketed lopinavir/ritonavir (LPV/r) tablet formulation with the marketed soft gel capsule (SGC) formulation and to compare the safety, tolerability, and antiviral activity of once daily (QD) and twice daily (BID) dosing of the LPV/r tablet formulation in combination with select nucleoside reverse transcriptase inhibitors (NRTIs) in patients who have not previously received antiretroviral treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus Infections
Keywords
Human Immunodeficiency Virus Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
664 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LPV/r 800/200 mg QD Tablet
Arm Type
Experimental
Arm Title
LPV/r 800/200 mg QD SGC (Through Week 8)
Arm Type
Experimental
Arm Title
LPV/r 400/100 mg BID Tablet
Arm Type
Active Comparator
Arm Title
LPV/r 400/100 mg BID SGC (Through Week 8)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
Other Intervention Name(s)
ABT-378, Kaletra, lopinavir/ritonavir
Intervention Description
LPV/r 800/200 mg once daily (QD) tablet + emtricitabine (FTC) 200 mg QD + tenofovir disoproxil fumarate (TDF) 300 mg QD
Intervention Type
Drug
Intervention Name(s)
lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
Other Intervention Name(s)
ABT-378, Kaletra, lopinavir/ritonavir
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
Other Intervention Name(s)
ABT-378, Kaletra, lopinavir/ritonavir
Intervention Description
LPV/r 400/100 mg twice daily (BID) tablet + FTC 200 mg QD + TDF 300 mg QD
Intervention Type
Drug
Intervention Name(s)
lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
Other Intervention Name(s)
ABT-378, Kaletra, lopinavir/ritonavir
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks
Time Frame
Week 8
Title
Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 48
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 96
Time Frame
Week 96 (End of Study)
Title
Mean Change From Baseline to Week 96 in CD4+ T Cell Counts
Time Frame
Week 96 (End of Study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Subjects were human immunodeficiency virus type 1 (HIV-1) positive, antiretroviral naïve adults at least 18 years of age with < 7 days of prior antiretroviral therapy. Subjects had plasma HIV-1 ribonucleic acid (RNA) levels >= 1,000 copies/mL at screening and were not acutely ill. Female subjects were nonpregnant and nonlactating. Exclusion Criteria Subjects were excluded if screening laboratory analyses showed any of the following abnormal laboratory results: Presence of hepatitis B surface antigen (HBsAg) Hemoglobin <= 8.0 g/dL Absolute neutrophil count <= 750 cells/microliter Platelet count <= 50,000 per mL Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 3.0 x Upper Limit of Normal (ULN) Calculated creatinine clearance < 50 mL/min
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel E Cohen, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 823
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Site Reference ID/Investigator# 846
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Site Reference ID/Investigator# 851
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Site Reference ID/Investigator# 872
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Site Reference ID/Investigator# 826
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Site Reference ID/Investigator# 876
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Site Reference ID/Investigator# 875
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Site Reference ID/Investigator# 870
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Site Reference ID/Investigator# 844
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33311
Country
United States
Facility Name
Site Reference ID/Investigator# 874
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Site Reference ID/Investigator# 1153
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Site Reference ID/Investigator# 827
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Site Reference ID/Investigator# 783
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
Site Reference ID/Investigator# 877
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Site Reference ID/Investigator# 845
City
Safety Harbor
State/Province
Florida
ZIP/Postal Code
34695
Country
United States
Facility Name
Site Reference ID/Investigator# 849
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
Site Reference ID/Investigator# 825
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Site Reference ID/Investigator# 848
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Site Reference ID/Investigator# 873
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Site Reference ID/Investigator# 1154
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Site Reference ID/Investigator# 824
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60613
Country
United States
Facility Name
Site Reference ID/Investigator# 792
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Site Reference ID/Investigator# 1157
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Site Reference ID/Investigator# 871
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Site Reference ID/Investigator# 2450
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Site Reference ID/Investigator# 784
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Site Reference ID/Investigator# 1155
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Facility Name
Site Reference ID/Investigator# 850
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Site Reference ID/Investigator# 843
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Site Reference ID/Investigator# 1156
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
Site Reference ID/Investigator# 244
City
Darlinghurst
ZIP/Postal Code
2010
Country
Australia
Facility Name
Site Reference ID/Investigator# 245
City
Melbourne
ZIP/Postal Code
3004
Country
Australia
Facility Name
Site Reference ID/Investigator# 246
City
South Yarra
ZIP/Postal Code
3141
Country
Australia
Facility Name
Site Reference ID/Investigator# 234
City
Antwerp
ZIP/Postal Code
2000
Country
Belgium
Facility Name
Site Reference ID/Investigator# 235
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Site Reference ID/Investigator# 233
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Site Reference ID/Investigator# 236
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Site Reference ID/Investigator# 225
City
Liege 1
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Site Reference ID/Investigator# 175
City
Calgary
ZIP/Postal Code
T2R 0X7
Country
Canada
Facility Name
Site Reference ID/Investigator# 184
City
Hamilton
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Site Reference ID/Investigator# 177
City
Montreal
ZIP/Postal Code
H2L 4P9
Country
Canada
Facility Name
Site Reference ID/Investigator# 176
City
Montreal
ZIP/Postal Code
H2L 5B1
Country
Canada
Facility Name
Site Reference ID/Investigator# 179
City
Montreal
ZIP/Postal Code
H2X 2P4
Country
Canada
Facility Name
Site Reference ID/Investigator# 181
City
Ottawa
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Site Reference ID/Investigator# 173
City
Ottawa
ZIP/Postal Code
K1N 6N5
Country
Canada
Facility Name
Site Reference ID/Investigator# 178
City
Ste-Foy
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Site Reference ID/Investigator# 180
City
Toronto
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Site Reference ID/Investigator# 182
City
Toronto
ZIP/Postal Code
M5B 1L6
Country
Canada
Facility Name
Site Reference ID/Investigator# 174
City
Toronto
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Site Reference ID/Investigator# 183
City
Vancouver
ZIP/Postal Code
V6Z 2C7
Country
Canada
Facility Name
Site Reference ID/Investigator# 172
City
Vancouver
ZIP/Postal Code
V6Z 2T1
Country
Canada
Facility Name
Site Reference ID/Investigator# 294
City
Brno
ZIP/Postal Code
639 00
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 296
City
Plzen
ZIP/Postal Code
305 99
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 286
City
Aix en Provence
ZIP/Postal Code
13616
Country
France
Facility Name
Site Reference ID/Investigator# 275
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Site Reference ID/Investigator# 256
City
Lyon
ZIP/Postal Code
69288
Country
France
Facility Name
Site Reference ID/Investigator# 278
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Site Reference ID/Investigator# 257
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Site Reference ID/Investigator# 281
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Site Reference ID/Investigator# 280
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Site Reference ID/Investigator# 279
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
Site Reference ID/Investigator# 284
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Site Reference ID/Investigator# 274
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Site Reference ID/Investigator# 282
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Site Reference ID/Investigator# 265
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Site Reference ID/Investigator# 270
City
Berlin
ZIP/Postal Code
D-10243
Country
Germany
Facility Name
Site Reference ID/Investigator# 262
City
Bochum
ZIP/Postal Code
D-44791
Country
Germany
Facility Name
Site Reference ID/Investigator# 268
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Site Reference ID/Investigator# 271
City
Cologne
ZIP/Postal Code
50931
Country
Germany
Facility Name
Site Reference ID/Investigator# 266
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Site Reference ID/Investigator# 264
City
Fuerth
ZIP/Postal Code
D-90762
Country
Germany
Facility Name
Site Reference ID/Investigator# 273
City
Hamburg
ZIP/Postal Code
20146
Country
Germany
Facility Name
Site Reference ID/Investigator# 267
City
Hamburg
ZIP/Postal Code
D-20099
Country
Germany
Facility Name
Site Reference ID/Investigator# 263
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Site Reference ID/Investigator# 211
City
Athens
ZIP/Postal Code
115 26
Country
Greece
Facility Name
Site Reference ID/Investigator# 207
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
Site Reference ID/Investigator# 249
City
Dublin 7
Country
Ireland
Facility Name
Site Reference ID/Investigator# 237
City
Dublin 8
Country
Ireland
Facility Name
Site Reference ID/Investigator# 203
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Site Reference ID/Investigator# 192
City
Florence
ZIP/Postal Code
50011
Country
Italy
Facility Name
Site Reference ID/Investigator# 195
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Site Reference ID/Investigator# 201
City
Milan
ZIP/Postal Code
20127
Country
Italy
Facility Name
Site Reference ID/Investigator# 198
City
Milan
ZIP/Postal Code
20157
Country
Italy
Facility Name
Site Reference ID/Investigator# 199
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Site Reference ID/Investigator# 200
City
Rome
ZIP/Postal Code
00149
Country
Italy
Facility Name
Site Reference ID/Investigator# 196
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Site Reference ID/Investigator# 194
City
Rome
ZIP/Postal Code
00184
Country
Italy
Facility Name
Site Reference ID/Investigator# 193
City
Turin
ZIP/Postal Code
10149
Country
Italy
Facility Name
Site Reference ID/Investigator# 290
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Site Reference ID/Investigator# 298
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Site Reference ID/Investigator# 299
City
Warsaw
ZIP/Postal Code
01-201
Country
Poland
Facility Name
Site Reference ID/Investigator# 297
City
Wroclaw
ZIP/Postal Code
51-149
Country
Poland
Facility Name
Site Reference ID/Investigator# 185
City
Ponce
ZIP/Postal Code
00717-1563
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 208
City
Ponce
ZIP/Postal Code
00731
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 206
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 186
City
Moscow
ZIP/Postal Code
105275
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 189
City
Moscow
ZIP/Postal Code
105275
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 188
City
St. Petersburg
ZIP/Postal Code
190020
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 5163
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Site Reference ID/Investigator# 221
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Site Reference ID/Investigator# 210
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Site Reference ID/Investigator# 190
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Site Reference ID/Investigator# 214
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Site Reference ID/Investigator# 216
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Site Reference ID/Investigator# 222
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Site Reference ID/Investigator# 224
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Site Reference ID/Investigator# 218
City
Barcelona
ZIP/Postal Code
8907
Country
Spain
Facility Name
Site Reference ID/Investigator# 292
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Site Reference ID/Investigator# 205
City
Madrid
ZIP/Postal Code
28029
Country
Spain
Facility Name
Site Reference ID/Investigator# 191
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Site Reference ID/Investigator# 219
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Site Reference ID/Investigator# 209
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Site Reference ID/Investigator# 223
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Site Reference ID/Investigator# 213
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Site Reference ID/Investigator# 217
City
Santiago de Compostela
ZIP/Postal Code
15705
Country
Spain
Facility Name
Site Reference ID/Investigator# 220
City
Seville
ZIP/Postal Code
41013
Country
Spain
Facility Name
Site Reference ID/Investigator# 215
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Site Reference ID/Investigator# 288
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Site Reference ID/Investigator# 289
City
Geneva 14
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Site Reference ID/Investigator# 243
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Site Reference ID/Investigator# 254
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Site Reference ID/Investigator# 241
City
Taipei City
ZIP/Postal Code
10016
Country
Taiwan
Facility Name
Site Reference ID/Investigator# 238
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 232
City
Brighton
ZIP/Postal Code
BN2 1ES
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 226
City
London
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 231
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 227
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 228
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 229
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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