Clinical trial 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
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Human Immunodeficiency Virus Infections
Keywords: Human Immunodeficiency Virus Infections
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-12-07
Enrollment: 664
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks
timeFrame: Week 8
measure: Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 48
timeFrame: Week 48
Secondary outcomes:
measure: Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 96
timeFrame: Week 96 (End of Study)
measure: Mean Change From Baseline to Week 96 in CD4+ T Cell Counts
timeFrame: Week 96 (End of Study)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Site Reference ID/Investigator# 823
state: Arizona
city: Phoenix
country: United States
facility: Site Reference ID/Investigator# 846
state: Arizona
city: Beverly Hills
country: United States
facility: Site Reference ID/Investigator# 851
state: California
city: Fountain Valley
country: United States
facility: Site Reference ID/Investigator# 872
state: California
city: Long Beach
country: United States
facility: Site Reference ID/Investigator# 826
state: California
city: Newport Beach
country: United States
facility: Site Reference ID/Investigator# 876
state: California
city: Washington
country: United States
facility: Site Reference ID/Investigator# 875
state: District of Columbia
city: Atlantis
country: United States
facility: Site Reference ID/Investigator# 870
state: Florida
city: Fort Lauderdale
country: United States
facility: Site Reference ID/Investigator# 844
state: Florida
city: Miami
country: United States
facility: Site Reference ID/Investigator# 874
state: Florida
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 1153
state: Florida
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 827
state: Florida
city: Plantation
country: United States
facility: Site Reference ID/Investigator# 783
state: Florida
city: Port Saint Lucie
country: United States
facility: Site Reference ID/Investigator# 877
state: Florida
city: Safety Harbor
country: United States
facility: Site Reference ID/Investigator# 845
state: Florida
city: Sarasota
country: United States
facility: Site Reference ID/Investigator# 849
state: Florida
city: Tampa
country: United States
facility: Site Reference ID/Investigator# 825
state: Florida
city: Atlanta
country: United States
facility: Site Reference ID/Investigator# 848
state: Georgia
city: Macon
country: United States
facility: Site Reference ID/Investigator# 873
state: Georgia
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 1154
state: Illinois
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 824
state: Illinois
city: Wichita
country: United States
facility: Site Reference ID/Investigator# 792
state: Kansas
city: Minneapolis
country: United States
facility: Site Reference ID/Investigator# 1157
state: Minnesota
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 871
state: Missouri
city: Rochester
country: United States
facility: Site Reference ID/Investigator# 2450
state: New York
city: Charlotte
country: United States
facility: Site Reference ID/Investigator# 784
state: North Carolina
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 1155
state: Texas
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 850
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 843
state: Texas
city: Hampton
country: United States
facility: Site Reference ID/Investigator# 1156
state: Virginia
city: Darlinghurst
country: Australia
facility: Site Reference ID/Investigator# 244
city: Melbourne
country: Australia
facility: Site Reference ID/Investigator# 245
city: South Yarra
country: Australia
facility: Site Reference ID/Investigator# 246
city: Antwerp
country: Belgium
facility: Site Reference ID/Investigator# 234
city: Brussels
country: Belgium
facility: Site Reference ID/Investigator# 235
city: Ghent
country: Belgium
facility: Site Reference ID/Investigator# 233
city: Leuven
country: Belgium
facility: Site Reference ID/Investigator# 236
city: Liege 1
country: Belgium
facility: Site Reference ID/Investigator# 225
city: Calgary
country: Canada
facility: Site Reference ID/Investigator# 175
city: Hamilton
country: Canada
facility: Site Reference ID/Investigator# 184
city: Montreal
country: Canada
facility: Site Reference ID/Investigator# 177
city: Montreal
country: Canada
facility: Site Reference ID/Investigator# 176
city: Montreal
country: Canada
facility: Site Reference ID/Investigator# 179
city: Ottawa
country: Canada
facility: Site Reference ID/Investigator# 181
city: Ottawa
country: Canada
facility: Site Reference ID/Investigator# 173
city: Ste-Foy
country: Canada
facility: Site Reference ID/Investigator# 178
city: Toronto
country: Canada
facility: Site Reference ID/Investigator# 180
city: Toronto
country: Canada
facility: Site Reference ID/Investigator# 182
city: Toronto
country: Canada
facility: Site Reference ID/Investigator# 174
city: Vancouver
country: Canada
facility: Site Reference ID/Investigator# 183
city: Vancouver
country: Canada
facility: Site Reference ID/Investigator# 172
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 294
city: Plzen
country: Czech Republic
facility: Site Reference ID/Investigator# 296
city: Aix en Provence
country: France
facility: Site Reference ID/Investigator# 286
city: Besancon
country: France
facility: Site Reference ID/Investigator# 275
city: Lyon
country: France
facility: Site Reference ID/Investigator# 256
city: Montpellier Cedex 5
country: France
facility: Site Reference ID/Investigator# 278
city: Paris
country: France
facility: Site Reference ID/Investigator# 257
city: Paris
country: France
facility: Site Reference ID/Investigator# 281
city: Paris
country: France
facility: Site Reference ID/Investigator# 280
city: Paris
country: France
facility: Site Reference ID/Investigator# 279
city: Paris
country: France
facility: Site Reference ID/Investigator# 284
city: Rennes
country: France
facility: Site Reference ID/Investigator# 274
city: Vandoeuvre les Nancy
country: France
facility: Site Reference ID/Investigator# 282
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 265
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 270
city: Bochum
country: Germany
facility: Site Reference ID/Investigator# 262
city: Bonn
country: Germany
facility: Site Reference ID/Investigator# 268
city: Cologne
country: Germany
facility: Site Reference ID/Investigator# 271
city: Frankfurt
country: Germany
facility: Site Reference ID/Investigator# 266
city: Fuerth
country: Germany
facility: Site Reference ID/Investigator# 264
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 273
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 267
city: Hannover
country: Germany
facility: Site Reference ID/Investigator# 263
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 211
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 207
city: Dublin 7
country: Ireland
facility: Site Reference ID/Investigator# 249
city: Dublin 8
country: Ireland
facility: Site Reference ID/Investigator# 237
city: Brescia
country: Italy
facility: Site Reference ID/Investigator# 203
city: Florence
country: Italy
facility: Site Reference ID/Investigator# 192
city: Genoa
country: Italy
facility: Site Reference ID/Investigator# 195
city: Milan
country: Italy
facility: Site Reference ID/Investigator# 201
city: Milan
country: Italy
facility: Site Reference ID/Investigator# 198
city: Pavia
country: Italy
facility: Site Reference ID/Investigator# 199
city: Rome
country: Italy
facility: Site Reference ID/Investigator# 200
city: Rome
country: Italy
facility: Site Reference ID/Investigator# 196
city: Rome
country: Italy
facility: Site Reference ID/Investigator# 194
city: Turin
country: Italy
facility: Site Reference ID/Investigator# 193
city: Zwolle
country: Netherlands
facility: Site Reference ID/Investigator# 290
city: Chorzow
country: Poland
facility: Site Reference ID/Investigator# 298
city: Warsaw
country: Poland
facility: Site Reference ID/Investigator# 299
city: Wroclaw
country: Poland
facility: Site Reference ID/Investigator# 297
city: Ponce
country: Puerto Rico
facility: Site Reference ID/Investigator# 185
city: Ponce
country: Puerto Rico
facility: Site Reference ID/Investigator# 208
city: San Juan
country: Puerto Rico
facility: Site Reference ID/Investigator# 206
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 186
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 189
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 188
city: Singapore
country: Singapore
facility: Site Reference ID/Investigator# 5163
city: A Coruna
country: Spain
facility: Site Reference ID/Investigator# 221
city: Alicante
country: Spain
facility: Site Reference ID/Investigator# 210
city: Barakaldo
country: Spain
facility: Site Reference ID/Investigator# 190
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 214
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 216
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 222
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 224
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 218
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 292
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 205
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 191
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 219
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 209
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 223
city: Santander
country: Spain
facility: Site Reference ID/Investigator# 213
city: Santiago de Compostela
country: Spain
facility: Site Reference ID/Investigator# 217
city: Seville
country: Spain
facility: Site Reference ID/Investigator# 220
city: Valencia
country: Spain
facility: Site Reference ID/Investigator# 215
city: Basel
country: Switzerland
facility: Site Reference ID/Investigator# 288
city: Geneva 14
country: Switzerland
facility: Site Reference ID/Investigator# 289
city: Lausanne
country: Switzerland
facility: Site Reference ID/Investigator# 243
city: St. Gallen
country: Switzerland
facility: Site Reference ID/Investigator# 254
city: Taipei City
country: Taiwan
facility: Site Reference ID/Investigator# 241
city: Birmingham
country: United Kingdom
facility: Site Reference ID/Investigator# 238
city: Brighton
country: United Kingdom
facility: Site Reference ID/Investigator# 232
city: London
country: United Kingdom
facility: Site Reference ID/Investigator# 226
city: London
country: United Kingdom
facility: Site Reference ID/Investigator# 231
city: London
country: United Kingdom
facility: Site Reference ID/Investigator# 227
city: London
country: United Kingdom
facility: Site Reference ID/Investigator# 228
city: Manchester
country: United Kingdom
facility: Site Reference ID/Investigator# 229
Study officials:
affiliation: Abbott
name: Daniel E Cohen, MD
role: STUDY_DIRECTOR
References: