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
- Conditions
- Human Immunodeficiency Virus Infections
- Interventions
- Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
- Registration Number
- NCT00262522
- Lead Sponsor
- Abbott
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 664
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LPV/r 800/200 mg QD Tablet lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs) - LPV/r 800/200 mg QD SGC (Through Week 8) lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs) - LPV/r 400/100 mg BID Tablet lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs) - LPV/r 400/100 mg BID SGC (Through Week 8) lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs) -
- Primary Outcome Measures
Name Time Method Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks Week 8 Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 48 Week 48
- Secondary Outcome Measures
Name Time Method Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 96 Week 96 (End of Study) Mean Change From Baseline to Week 96 in CD4+ T Cell Counts Week 96 (End of Study)
Trial Locations
- Locations (129)
Site Reference ID/Investigator# 872
🇺🇸Fountain Valley, California, United States
Site Reference ID/Investigator# 845
🇺🇸Safety Harbor, Florida, United States
Site Reference ID/Investigator# 1155
🇺🇸Dallas, Texas, United States
Site Reference ID/Investigator# 1154
🇺🇸Chicago, Illinois, United States
Site Reference ID/Investigator# 249
🇮🇪Dublin 7, Ireland
Site Reference ID/Investigator# 237
🇮🇪Dublin 8, Ireland
Site Reference ID/Investigator# 296
🇨🇿Plzen, Czech Republic
Site Reference ID/Investigator# 874
🇺🇸Miami, Florida, United States
Site Reference ID/Investigator# 1157
🇺🇸Minneapolis, Minnesota, United States
Site Reference ID/Investigator# 843
🇺🇸Houston, Texas, United States
Site Reference ID/Investigator# 223
🇪🇸Madrid, Spain
Site Reference ID/Investigator# 213
🇪🇸Santander, Spain
Site Reference ID/Investigator# 217
🇪🇸Santiago de Compostela, Spain
Site Reference ID/Investigator# 877
🇺🇸Port Saint Lucie, Florida, United States
Site Reference ID/Investigator# 875
🇺🇸Washington, District of Columbia, United States
Site Reference ID/Investigator# 844
🇺🇸Fort Lauderdale, Florida, United States
Site Reference ID/Investigator# 824
🇺🇸Chicago, Illinois, United States
Site Reference ID/Investigator# 871
🇺🇸St. Louis, Missouri, United States
Site Reference ID/Investigator# 792
🇺🇸Wichita, Kansas, United States
Site Reference ID/Investigator# 2450
🇺🇸Rochester, New York, United States
Site Reference ID/Investigator# 850
🇺🇸Dallas, Texas, United States
Site Reference ID/Investigator# 784
🇺🇸Charlotte, North Carolina, United States
Site Reference ID/Investigator# 1156
🇺🇸Hampton, Virginia, United States
Site Reference ID/Investigator# 184
🇨🇦Hamilton, Canada
Site Reference ID/Investigator# 235
🇧🇪Brussels, Belgium
Site Reference ID/Investigator# 176
🇨🇦Montreal, Canada
Site Reference ID/Investigator# 233
🇧🇪Ghent, Belgium
Site Reference ID/Investigator# 172
🇨🇦Vancouver, Canada
Site Reference ID/Investigator# 294
🇨🇿Brno, Czech Republic
Site Reference ID/Investigator# 236
🇧🇪Leuven, Belgium
Site Reference ID/Investigator# 225
🇧🇪Liege 1, Belgium
Site Reference ID/Investigator# 183
🇨🇦Vancouver, Canada
Site Reference ID/Investigator# 257
🇫🇷Paris, France
Site Reference ID/Investigator# 275
🇫🇷Besancon, France
Site Reference ID/Investigator# 256
🇫🇷Lyon, France
Site Reference ID/Investigator# 278
🇫🇷Montpellier Cedex 5, France
Site Reference ID/Investigator# 280
🇫🇷Paris, France
Site Reference ID/Investigator# 279
🇫🇷Paris, France
Site Reference ID/Investigator# 284
🇫🇷Paris, France
Site Reference ID/Investigator# 268
🇩🇪Bonn, Germany
Site Reference ID/Investigator# 266
🇩🇪Frankfurt, Germany
Site Reference ID/Investigator# 264
🇩🇪Fuerth, Germany
Site Reference ID/Investigator# 282
🇫🇷Vandoeuvre les Nancy, France
Site Reference ID/Investigator# 262
🇩🇪Bochum, Germany
Site Reference ID/Investigator# 273
🇩🇪Hamburg, Germany
Site Reference ID/Investigator# 263
🇩🇪Hannover, Germany
Site Reference ID/Investigator# 267
🇩🇪Hamburg, Germany
Site Reference ID/Investigator# 207
🇬🇷Thessaloniki, Greece
Site Reference ID/Investigator# 195
🇮🇹Genoa, Italy
Site Reference ID/Investigator# 194
🇮🇹Rome, Italy
Site Reference ID/Investigator# 299
🇵🇱Warsaw, Poland
Site Reference ID/Investigator# 193
🇮🇹Turin, Italy
Site Reference ID/Investigator# 198
🇮🇹Milan, Italy
Site Reference ID/Investigator# 199
🇮🇹Pavia, Italy
Site Reference ID/Investigator# 200
🇮🇹Rome, Italy
Site Reference ID/Investigator# 196
🇮🇹Rome, Italy
Site Reference ID/Investigator# 218
🇪🇸Barcelona, Spain
Site Reference ID/Investigator# 292
🇪🇸Madrid, Spain
Site Reference ID/Investigator# 241
🇨🇳Taipei City, Taiwan
Site Reference ID/Investigator# 221
🇪🇸A Coruna, Spain
Site Reference ID/Investigator# 210
🇪🇸Alicante, Spain
Site Reference ID/Investigator# 205
🇪🇸Madrid, Spain
Site Reference ID/Investigator# 209
🇪🇸Madrid, Spain
Site Reference ID/Investigator# 219
🇪🇸Madrid, Spain
Site Reference ID/Investigator# 191
🇪🇸Madrid, Spain
Site Reference ID/Investigator# 288
🇨ðŸ‡Basel, Switzerland
Site Reference ID/Investigator# 254
🇨ðŸ‡St. Gallen, Switzerland
Site Reference ID/Investigator# 289
🇨ðŸ‡Geneva 14, Switzerland
Site Reference ID/Investigator# 238
🇬🇧Birmingham, United Kingdom
Site Reference ID/Investigator# 243
🇨ðŸ‡Lausanne, Switzerland
Site Reference ID/Investigator# 227
🇬🇧London, United Kingdom
Site Reference ID/Investigator# 228
🇬🇧London, United Kingdom
Site Reference ID/Investigator# 823
🇺🇸Phoenix, Arizona, United States
Site Reference ID/Investigator# 281
🇫🇷Paris, France
Site Reference ID/Investigator# 246
🇦🇺South Yarra, Australia
Site Reference ID/Investigator# 876
🇺🇸Newport Beach, California, United States
Site Reference ID/Investigator# 244
🇦🇺Darlinghurst, Australia
Site Reference ID/Investigator# 846
🇺🇸Phoenix, Arizona, United States
Site Reference ID/Investigator# 848
🇺🇸Atlanta, Georgia, United States
Site Reference ID/Investigator# 825
🇺🇸Tampa, Florida, United States
Site Reference ID/Investigator# 826
🇺🇸Long Beach, California, United States
Site Reference ID/Investigator# 851
🇺🇸Beverly Hills, California, United States
Site Reference ID/Investigator# 849
🇺🇸Sarasota, Florida, United States
Site Reference ID/Investigator# 783
🇺🇸Plantation, Florida, United States
Site Reference ID/Investigator# 870
🇺🇸Atlantis, Florida, United States
Site Reference ID/Investigator# 1153
🇺🇸Orlando, Florida, United States
Site Reference ID/Investigator# 873
🇺🇸Macon, Georgia, United States
Site Reference ID/Investigator# 827
🇺🇸Orlando, Florida, United States
Site Reference ID/Investigator# 245
🇦🇺Melbourne, Australia
Site Reference ID/Investigator# 175
🇨🇦Calgary, Canada
Site Reference ID/Investigator# 177
🇨🇦Montreal, Canada
Site Reference ID/Investigator# 179
🇨🇦Montreal, Canada
Site Reference ID/Investigator# 173
🇨🇦Ottawa, Canada
Site Reference ID/Investigator# 181
🇨🇦Ottawa, Canada
Site Reference ID/Investigator# 178
🇨🇦Ste-Foy, Canada
Site Reference ID/Investigator# 180
🇨🇦Toronto, Canada
Site Reference ID/Investigator# 182
🇨🇦Toronto, Canada
Site Reference ID/Investigator# 174
🇨🇦Toronto, Canada
Site Reference ID/Investigator# 286
🇫🇷Aix en Provence, France
Site Reference ID/Investigator# 274
🇫🇷Rennes, France
Site Reference ID/Investigator# 265
🇩🇪Berlin, Germany
Site Reference ID/Investigator# 270
🇩🇪Berlin, Germany
Site Reference ID/Investigator# 271
🇩🇪Cologne, Germany
Site Reference ID/Investigator# 211
🇬🇷Athens, Greece
Site Reference ID/Investigator# 192
🇮🇹Florence, Italy
Site Reference ID/Investigator# 203
🇮🇹Brescia, Italy
Site Reference ID/Investigator# 201
🇮🇹Milan, Italy
Site Reference ID/Investigator# 298
🇵🇱Chorzow, Poland
Site Reference ID/Investigator# 186
🇷🇺Moscow, Russian Federation
Site Reference ID/Investigator# 290
🇳🇱Zwolle, Netherlands
Site Reference ID/Investigator# 297
🇵🇱Wroclaw, Poland
Site Reference ID/Investigator# 185
🇵🇷Ponce, Puerto Rico
Site Reference ID/Investigator# 206
🇵🇷San Juan, Puerto Rico
Site Reference ID/Investigator# 208
🇵🇷Ponce, Puerto Rico
Site Reference ID/Investigator# 5163
🇸🇬Singapore, Singapore
Site Reference ID/Investigator# 188
🇷🇺St. Petersburg, Russian Federation
Site Reference ID/Investigator# 189
🇷🇺Moscow, Russian Federation
Site Reference ID/Investigator# 214
🇪🇸Barcelona, Spain
Site Reference ID/Investigator# 190
🇪🇸Barakaldo, Spain
Site Reference ID/Investigator# 222
🇪🇸Barcelona, Spain
Site Reference ID/Investigator# 216
🇪🇸Barcelona, Spain
Site Reference ID/Investigator# 224
🇪🇸Barcelona, Spain
Site Reference ID/Investigator# 220
🇪🇸Seville, Spain
Site Reference ID/Investigator# 215
🇪🇸Valencia, Spain
Site Reference ID/Investigator# 232
🇬🇧Brighton, United Kingdom
Site Reference ID/Investigator# 226
🇬🇧London, United Kingdom
Site Reference ID/Investigator# 231
🇬🇧London, United Kingdom
Site Reference ID/Investigator# 229
🇬🇧Manchester, United Kingdom
Site Reference ID/Investigator# 234
🇧🇪Antwerp, Belgium