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

Last updated: February 3, 2012
Sponsor: Abbott
Overall Status: Completed

Phase

3

Condition

Hiv Infections

Aids And Aids Related Infections

Hiv/aids

Treatment

N/A

Clinical Study ID

NCT00262522
M05-730
2005-001430-32
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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 Design

Total Participants: 664
Study Start date:
November 01, 2005
Estimated Completion Date:
July 31, 2008

Connect with a study center

  • Site Reference ID/Investigator# 244

    Darlinghurst, 2010
    Australia

    Site Not Available

  • Site Reference ID/Investigator# 245

    Melbourne, 3004
    Australia

    Site Not Available

  • Site Reference ID/Investigator# 246

    South Yarra, 3141
    Australia

    Site Not Available

  • Site Reference ID/Investigator# 234

    Antwerp, 2000
    Belgium

    Site Not Available

  • Site Reference ID/Investigator# 235

    Brussels, 1200
    Belgium

    Site Not Available

  • Site Reference ID/Investigator# 233

    Ghent, 9000
    Belgium

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  • Site Reference ID/Investigator# 236

    Leuven, 3000
    Belgium

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  • Site Reference ID/Investigator# 225

    Liege 1, 4000
    Belgium

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  • Site Reference ID/Investigator# 175

    Calgary, T2R 0X7
    Canada

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  • Site Reference ID/Investigator# 184

    Hamilton, L8N 3Z5
    Canada

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  • Site Reference ID/Investigator# 176

    Montreal, H2L 5B1
    Canada

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  • Site Reference ID/Investigator# 177

    Montreal, H2L 4P9
    Canada

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  • Site Reference ID/Investigator# 179

    Montreal, H2X 2P4
    Canada

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  • Site Reference ID/Investigator# 173

    Ottawa, K1N 6N5
    Canada

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  • Site Reference ID/Investigator# 181

    Ottawa, K1H 8L6
    Canada

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  • Site Reference ID/Investigator# 178

    Ste-Foy, G1V 4G2
    Canada

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  • Site Reference ID/Investigator# 174

    Toronto, M5G 2C4
    Canada

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  • Site Reference ID/Investigator# 180

    Toronto, M4N 3M5
    Canada

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  • Site Reference ID/Investigator# 182

    Toronto, M5B 1L6
    Canada

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  • Site Reference ID/Investigator# 172

    Vancouver, V6Z 2T1
    Canada

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  • Site Reference ID/Investigator# 183

    Vancouver, V6Z 2C7
    Canada

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  • Site Reference ID/Investigator# 294

    Brno, 639 00
    Czech Republic

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    Plzen, 305 99
    Czech Republic

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  • Site Reference ID/Investigator# 286

    Aix en Provence, 13616
    France

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    Besancon, 25030
    France

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    Lyon, 69288
    France

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    Montpellier Cedex 5, 34295
    France

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    Paris, 75012
    France

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    Paris, 75877
    France

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    Paris, 75475
    France

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    Paris, 75014
    France

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    Paris, 75970
    France

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    Rennes, 35033
    France

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    Vandoeuvre les Nancy, 54511
    France

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    Berlin, 13353
    Germany

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    Berlin, D-10243
    Germany

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    Bochum, D-44791
    Germany

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    Bonn, 53127
    Germany

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    Cologne, 50931
    Germany

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    Frankfurt, 60590
    Germany

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    Fuerth, D-90762
    Germany

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    Hamburg, D-20099
    Germany

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    Hamburg, 20146
    Germany

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    Hannover, 30159
    Germany

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    Athens, 115 26
    Greece

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    Thessaloniki, 54636
    Greece

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    Dublin 7,
    Ireland

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    Dublin 8,
    Ireland

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    Brescia, 25123
    Italy

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    Florence, 50011
    Italy

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    Genoa, 16132
    Italy

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    Milan, 20157
    Italy

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    Milan, 20127
    Italy

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    Pavia, 27100
    Italy

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    Rome, 00184
    Italy

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    Rome, 00161
    Italy

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  • Site Reference ID/Investigator# 200

    Rome, 00149
    Italy

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    Turin, 10149
    Italy

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    Zwolle, 8025 AB
    Netherlands

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  • Site Reference ID/Investigator# 298

    Chorzow, 41-500
    Poland

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    Warsaw, 01-201
    Poland

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    Wroclaw, 51-149
    Poland

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  • Site Reference ID/Investigator# 185

    Ponce, 00717-1563
    Puerto Rico

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    Ponce, 00731
    Puerto Rico

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    San Juan, 00936-5067
    Puerto Rico

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  • Site Reference ID/Investigator# 186

    Moscow, 105275
    Russian Federation

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    Moscow, 105275
    Russian Federation

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  • Site Reference ID/Investigator# 188

    St. Petersburg, 190020
    Russian Federation

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  • Site Reference ID/Investigator# 5163

    Singapore, 308433
    Singapore

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    A Coruna, 15006
    Spain

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    Alicante, 03010
    Spain

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    Barakaldo, 48903
    Spain

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    Barcelona, 08035
    Spain

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    Barcelona, 08041
    Spain

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    Barcelona, 8907
    Spain

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    Barcelona, 08916
    Spain

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    Barcelona, 8036
    Spain

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  • Site Reference ID/Investigator# 191

    Madrid, 28034
    Spain

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    Madrid, 28029
    Spain

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    Madrid, 28041
    Spain

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    Madrid, 28040
    Spain

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    Madrid, 28046
    Spain

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    Madrid, 28007
    Spain

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  • Site Reference ID/Investigator# 213

    Santander, 39008
    Spain

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  • Site Reference ID/Investigator# 217

    Santiago de Compostela, 15705
    Spain

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  • Site Reference ID/Investigator# 220

    Seville, 41013
    Spain

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  • Site Reference ID/Investigator# 215

    Valencia, 46009
    Spain

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  • Site Reference ID/Investigator# 288

    Basel, 4031
    Switzerland

    Site Not Available

  • Site Reference ID/Investigator# 289

    Geneva 14, 1211
    Switzerland

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  • Site Reference ID/Investigator# 243

    Lausanne, 1011
    Switzerland

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  • Site Reference ID/Investigator# 254

    St. Gallen, 9007
    Switzerland

    Site Not Available

  • Site Reference ID/Investigator# 241

    Taipei City, 10016
    Taiwan

    Site Not Available

  • Site Reference ID/Investigator# 238

    Birmingham, B9 5SS
    United Kingdom

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  • Site Reference ID/Investigator# 232

    Brighton, BN2 1ES
    United Kingdom

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  • Site Reference ID/Investigator# 226

    London, N18 1QX
    United Kingdom

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    London, SW17 0QT
    United Kingdom

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    London, W2 1NY
    United Kingdom

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    London, NW3 2QG
    United Kingdom

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  • Site Reference ID/Investigator# 229

    Manchester, M8 5RB
    United Kingdom

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  • Site Reference ID/Investigator# 823

    Phoenix, Arizona 85006
    United States

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  • Site Reference ID/Investigator# 846

    Phoenix, Arizona 85012
    United States

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  • Site Reference ID/Investigator# 851

    Beverly Hills, California 90211
    United States

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  • Site Reference ID/Investigator# 872

    Fountain Valley, California 92708
    United States

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  • Site Reference ID/Investigator# 826

    Long Beach, California 90813
    United States

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  • Site Reference ID/Investigator# 876

    Newport Beach, California 92663
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  • Site Reference ID/Investigator# 875

    Washington, District of Columbia 20037
    United States

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  • Site Reference ID/Investigator# 870

    Atlantis, Florida 33462
    United States

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  • Site Reference ID/Investigator# 844

    Fort Lauderdale, Florida 33311
    United States

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  • Site Reference ID/Investigator# 874

    Miami, Florida 33136
    United States

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  • Site Reference ID/Investigator# 1153

    Orlando, Florida 32803
    United States

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  • Site Reference ID/Investigator# 827

    Orlando, Florida 32803
    United States

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  • Site Reference ID/Investigator# 783

    Plantation, Florida 33317
    United States

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  • Site Reference ID/Investigator# 877

    Port Saint Lucie, Florida 34952
    United States

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  • Site Reference ID/Investigator# 845

    Safety Harbor, Florida 34695
    United States

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  • Site Reference ID/Investigator# 849

    Sarasota, Florida 34243
    United States

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  • Site Reference ID/Investigator# 825

    Tampa, Florida 33614
    United States

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  • Site Reference ID/Investigator# 848

    Atlanta, Georgia 30309
    United States

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  • Site Reference ID/Investigator# 873

    Macon, Georgia 31201
    United States

    Site Not Available

  • Global Medical Information - Abbott

    Abbott Park, Illinois 60064
    United States

    Site Not Available

  • Site Reference ID/Investigator# 1154

    Chicago, Illinois 60612
    United States

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  • Site Reference ID/Investigator# 824

    Chicago, Illinois 60613
    United States

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  • Site Reference ID/Investigator# 792

    Wichita, Kansas 67214
    United States

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  • Site Reference ID/Investigator# 1157

    Minneapolis, Minnesota 55404
    United States

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  • Site Reference ID/Investigator# 871

    St. Louis, Missouri 63108
    United States

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  • Site Reference ID/Investigator# 2450

    Rochester, New York 14620
    United States

    Site Not Available

  • Site Reference ID/Investigator# 784

    Charlotte, North Carolina 28209
    United States

    Site Not Available

  • Site Reference ID/Investigator# 1155

    Dallas, Texas 75208
    United States

    Site Not Available

  • Site Reference ID/Investigator# 850

    Dallas, Texas 75246
    United States

    Site Not Available

  • Site Reference ID/Investigator# 843

    Houston, Texas 77004
    United States

    Site Not Available

  • Site Reference ID/Investigator# 1156

    Hampton, Virginia 23666
    United States

    Site Not Available

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