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

February 3, 2012 updated by: Abbott

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

664

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Darlinghurst, Australia, 2010
        • Site Reference ID/Investigator# 244
      • Melbourne, Australia, 3004
        • Site Reference ID/Investigator# 245
      • South Yarra, Australia, 3141
        • Site Reference ID/Investigator# 246
  • Belgium
      • Antwerp, Belgium, 2000
        • Site Reference ID/Investigator# 234
      • Brussels, Belgium, 1200
        • Site Reference ID/Investigator# 235
      • Ghent, Belgium, 9000
        • Site Reference ID/Investigator# 233
      • Leuven, Belgium, 3000
        • Site Reference ID/Investigator# 236
      • Liege 1, Belgium, 4000
        • Site Reference ID/Investigator# 225
  • Canada
      • Calgary, Canada, T2R 0X7
        • Site Reference ID/Investigator# 175
      • Hamilton, Canada, L8N 3Z5
        • Site Reference ID/Investigator# 184
      • Montreal, Canada, H2L 4P9
        • Site Reference ID/Investigator# 177
      • Montreal, Canada, H2L 5B1
        • Site Reference ID/Investigator# 176
      • Montreal, Canada, H2X 2P4
        • Site Reference ID/Investigator# 179
      • Ottawa, Canada, K1H 8L6
        • Site Reference ID/Investigator# 181
      • Ottawa, Canada, K1N 6N5
        • Site Reference ID/Investigator# 173
      • Ste-Foy, Canada, G1V 4G2
        • Site Reference ID/Investigator# 178
      • Toronto, Canada, M4N 3M5
        • Site Reference ID/Investigator# 180
      • Toronto, Canada, M5B 1L6
        • Site Reference ID/Investigator# 182
      • Toronto, Canada, M5G 2C4
        • Site Reference ID/Investigator# 174
      • Vancouver, Canada, V6Z 2C7
        • Site Reference ID/Investigator# 183
      • Vancouver, Canada, V6Z 2T1
        • Site Reference ID/Investigator# 172
  • Czech Republic
      • Brno, Czech Republic, 639 00
        • Site Reference ID/Investigator# 294
      • Plzen, Czech Republic, 305 99
        • Site Reference ID/Investigator# 296
  • France
      • Aix en Provence, France, 13616
        • Site Reference ID/Investigator# 286
      • Besancon, France, 25030
        • Site Reference ID/Investigator# 275
      • Lyon, France, 69288
        • Site Reference ID/Investigator# 256
      • Montpellier Cedex 5, France, 34295
        • Site Reference ID/Investigator# 278
      • Paris, France, 75012
        • Site Reference ID/Investigator# 257
      • Paris, France, 75014
        • Site Reference ID/Investigator# 281
      • Paris, France, 75475
        • Site Reference ID/Investigator# 280
      • Paris, France, 75877
        • Site Reference ID/Investigator# 279
      • Paris, France, 75970
        • Site Reference ID/Investigator# 284
      • Rennes, France, 35033
        • Site Reference ID/Investigator# 274
      • Vandoeuvre les Nancy, France, 54511
        • Site Reference ID/Investigator# 282
  • Germany
      • Berlin, Germany, 13353
        • Site Reference ID/Investigator# 265
      • Berlin, Germany, D-10243
        • Site Reference ID/Investigator# 270
      • Bochum, Germany, D-44791
        • Site Reference ID/Investigator# 262
      • Bonn, Germany, 53127
        • Site Reference ID/Investigator# 268
      • Cologne, Germany, 50931
        • Site Reference ID/Investigator# 271
      • Frankfurt, Germany, 60590
        • Site Reference ID/Investigator# 266
      • Fuerth, Germany, D-90762
        • Site Reference ID/Investigator# 264
      • Hamburg, Germany, 20146
        • Site Reference ID/Investigator# 273
      • Hamburg, Germany, D-20099
        • Site Reference ID/Investigator# 267
      • Hannover, Germany, 30159
        • Site Reference ID/Investigator# 263
  • Greece
      • Athens, Greece, 115 26
        • Site Reference ID/Investigator# 211
      • Thessaloniki, Greece, 54636
        • Site Reference ID/Investigator# 207
  • Ireland
      • Dublin 7, Ireland
        • Site Reference ID/Investigator# 249
      • Dublin 8, Ireland
        • Site Reference ID/Investigator# 237
  • Italy
      • Brescia, Italy, 25123
        • Site Reference ID/Investigator# 203
      • Florence, Italy, 50011
        • Site Reference ID/Investigator# 192
      • Genoa, Italy, 16132
        • Site Reference ID/Investigator# 195
      • Milan, Italy, 20127
        • Site Reference ID/Investigator# 201
      • Milan, Italy, 20157
        • Site Reference ID/Investigator# 198
      • Pavia, Italy, 27100
        • Site Reference ID/Investigator# 199
      • Rome, Italy, 00149
        • Site Reference ID/Investigator# 200
      • Rome, Italy, 00161
        • Site Reference ID/Investigator# 196
      • Rome, Italy, 00184
        • Site Reference ID/Investigator# 194
      • Turin, Italy, 10149
        • Site Reference ID/Investigator# 193
  • Netherlands
      • Zwolle, Netherlands, 8025 AB
        • Site Reference ID/Investigator# 290
  • Poland
      • Chorzow, Poland, 41-500
        • Site Reference ID/Investigator# 298
      • Warsaw, Poland, 01-201
        • Site Reference ID/Investigator# 299
      • Wroclaw, Poland, 51-149
        • Site Reference ID/Investigator# 297
  • Puerto Rico
      • Ponce, Puerto Rico, 00717-1563
        • Site Reference ID/Investigator# 185
      • Ponce, Puerto Rico, 00731
        • Site Reference ID/Investigator# 208
      • San Juan, Puerto Rico, 00936-5067
        • Site Reference ID/Investigator# 206
  • Russian Federation
      • Moscow, Russian Federation, 105275
        • Site Reference ID/Investigator# 186
      • Moscow, Russian Federation, 105275
        • Site Reference ID/Investigator# 189
      • St. Petersburg, Russian Federation, 190020
        • Site Reference ID/Investigator# 188
  • Singapore
      • Singapore, Singapore, 308433
        • Site Reference ID/Investigator# 5163
  • Spain
      • A Coruna, Spain, 15006
        • Site Reference ID/Investigator# 221
      • Alicante, Spain, 03010
        • Site Reference ID/Investigator# 210
      • Barakaldo, Spain, 48903
        • Site Reference ID/Investigator# 190
      • Barcelona, Spain, 08035
        • Site Reference ID/Investigator# 214
      • Barcelona, Spain, 08041
        • Site Reference ID/Investigator# 216
      • Barcelona, Spain, 08916
        • Site Reference ID/Investigator# 222
      • Barcelona, Spain, 8036
        • Site Reference ID/Investigator# 224
      • Barcelona, Spain, 8907
        • Site Reference ID/Investigator# 218
      • Madrid, Spain, 28007
        • Site Reference ID/Investigator# 292
      • Madrid, Spain, 28029
        • Site Reference ID/Investigator# 205
      • Madrid, Spain, 28034
        • Site Reference ID/Investigator# 191
      • Madrid, Spain, 28040
        • Site Reference ID/Investigator# 219
      • Madrid, Spain, 28041
        • Site Reference ID/Investigator# 209
      • Madrid, Spain, 28046
        • Site Reference ID/Investigator# 223
      • Santander, Spain, 39008
        • Site Reference ID/Investigator# 213
      • Santiago de Compostela, Spain, 15705
        • Site Reference ID/Investigator# 217
      • Seville, Spain, 41013
        • Site Reference ID/Investigator# 220
      • Valencia, Spain, 46009
        • Site Reference ID/Investigator# 215
  • Switzerland
      • Basel, Switzerland, 4031
        • Site Reference ID/Investigator# 288
      • Geneva 14, Switzerland, 1211
        • Site Reference ID/Investigator# 289
      • Lausanne, Switzerland, 1011
        • Site Reference ID/Investigator# 243
      • St. Gallen, Switzerland, 9007
        • Site Reference ID/Investigator# 254
  • Taiwan
      • Taipei City, Taiwan, 10016
        • Site Reference ID/Investigator# 241
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Site Reference ID/Investigator# 238
      • Brighton, United Kingdom, BN2 1ES
        • Site Reference ID/Investigator# 232
      • London, United Kingdom, N18 1QX
        • Site Reference ID/Investigator# 226
      • London, United Kingdom, NW3 2QG
        • Site Reference ID/Investigator# 231
      • London, United Kingdom, SW17 0QT
        • Site Reference ID/Investigator# 227
      • London, United Kingdom, W2 1NY
        • Site Reference ID/Investigator# 228
      • Manchester, United Kingdom, M8 5RB
        • Site Reference ID/Investigator# 229
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Site Reference ID/Investigator# 823
      • Phoenix, Arizona, United States, 85012
        • Site Reference ID/Investigator# 846
    • California
      • Beverly Hills, California, United States, 90211
        • Site Reference ID/Investigator# 851
      • Fountain Valley, California, United States, 92708
        • Site Reference ID/Investigator# 872
      • Long Beach, California, United States, 90813
        • Site Reference ID/Investigator# 826
      • Newport Beach, California, United States, 92663
        • Site Reference ID/Investigator# 876
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Site Reference ID/Investigator# 875
    • Florida
      • Atlantis, Florida, United States, 33462
        • Site Reference ID/Investigator# 870
      • Fort Lauderdale, Florida, United States, 33311
        • Site Reference ID/Investigator# 844
      • Miami, Florida, United States, 33136
        • Site Reference ID/Investigator# 874
      • Orlando, Florida, United States, 32803
        • Site Reference ID/Investigator# 1153
      • Orlando, Florida, United States, 32803
        • Site Reference ID/Investigator# 827
      • Plantation, Florida, United States, 33317
        • Site Reference ID/Investigator# 783
      • Port Saint Lucie, Florida, United States, 34952
        • Site Reference ID/Investigator# 877
      • Safety Harbor, Florida, United States, 34695
        • Site Reference ID/Investigator# 845
      • Sarasota, Florida, United States, 34243
        • Site Reference ID/Investigator# 849
      • Tampa, Florida, United States, 33614
        • Site Reference ID/Investigator# 825
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Site Reference ID/Investigator# 848
      • Macon, Georgia, United States, 31201
        • Site Reference ID/Investigator# 873
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Site Reference ID/Investigator# 1154
      • Chicago, Illinois, United States, 60613
        • Site Reference ID/Investigator# 824
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Site Reference ID/Investigator# 792
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Site Reference ID/Investigator# 1157
    • Missouri
      • St. Louis, Missouri, United States, 63108
        • Site Reference ID/Investigator# 871
    • New York
      • Rochester, New York, United States, 14620
        • Site Reference ID/Investigator# 2450
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Site Reference ID/Investigator# 784
    • Texas
      • Dallas, Texas, United States, 75208
        • Site Reference ID/Investigator# 1155
      • Dallas, Texas, United States, 75246
        • Site Reference ID/Investigator# 850
      • Houston, Texas, United States, 77004
        • Site Reference ID/Investigator# 843
    • Virginia
      • Hampton, Virginia, United States, 23666
        • Site Reference ID/Investigator# 1156

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LPV/r 800/200 mg QD Tablet
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
Other Names:
  • ABT-378, Kaletra, lopinavir/ritonavir
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
Other Names:
  • ABT-378, Kaletra, lopinavir/ritonavir
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
Other Names:
  • ABT-378, Kaletra, lopinavir/ritonavir
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
Other Names:
  • ABT-378, Kaletra, lopinavir/ritonavir
Active Comparator: LPV/r 400/100 mg BID Tablet
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
Other Names:
  • ABT-378, Kaletra, lopinavir/ritonavir
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
Other Names:
  • ABT-378, Kaletra, lopinavir/ritonavir
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
Other Names:
  • ABT-378, Kaletra, lopinavir/ritonavir
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
Other Names:
  • ABT-378, Kaletra, lopinavir/ritonavir
Experimental: LPV/r 800/200 mg QD SGC (Through Week 8)
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
Other Names:
  • ABT-378, Kaletra, lopinavir/ritonavir
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
Other Names:
  • ABT-378, Kaletra, lopinavir/ritonavir
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
Other Names:
  • ABT-378, Kaletra, lopinavir/ritonavir
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
Other Names:
  • ABT-378, Kaletra, lopinavir/ritonavir
Active Comparator: LPV/r 400/100 mg BID SGC (Through Week 8)
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
Other Names:
  • ABT-378, Kaletra, lopinavir/ritonavir
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
Other Names:
  • ABT-378, Kaletra, lopinavir/ritonavir
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
Other Names:
  • ABT-378, Kaletra, lopinavir/ritonavir
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
Other Names:
  • ABT-378, Kaletra, lopinavir/ritonavir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks
Time Frame: Week 8
Week 8
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
Week 48

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Week 96 (End of Study)
Mean Change From Baseline to Week 96 in CD4+ T Cell Counts
Time Frame: Week 96 (End of Study)
Week 96 (End of Study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Daniel E Cohen, MD, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

December 5, 2005

First Submitted That Met QC Criteria

December 5, 2005

First Posted (Estimate)

December 7, 2005

Study Record Updates

Last Update Posted (Estimate)

February 6, 2012

Last Update Submitted That Met QC Criteria

February 3, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M05-730
  • 2005-001430-32 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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