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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00262522
First received: December 5, 2005
Last updated: February 3, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Human Immunodeficiency Virus Infections
Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

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 [ Time Frame: Week 96 (End of Study) ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 96 in CD4+ T Cell Counts [ Time Frame: Week 96 (End of Study) ] [ Designated as safety issue: No ]

Enrollment: 664
Study Start Date: November 2005
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 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 Name: 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 400/100 mg twice daily (BID) tablet + FTC 200 mg QD + TDF 300 mg QD
Other Name: 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 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 Name: ABT-378, Kaletra, lopinavir/ritonavir

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00262522

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

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00262522     History of Changes
Other Study ID Numbers: M05-730, 2005-001430-32
Study First Received: December 5, 2005
Results First Received: July 9, 2009
Last Updated: February 3, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Ministry of Social Affairs, Public Health and the Environment
Canada: Health Canada
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Ireland: Irish Medicines Board
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
Taiwan : Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Abbott:
Human Immunodeficiency Virus Infections

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Infection
Virus Diseases
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Lopinavir
Reverse Transcriptase Inhibitors
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014