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

December 5, 2005
February 3, 2012
November 2005
July 2008   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00262522 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
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
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Human Immunodeficiency Virus Infections
  • 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
  • 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
  • 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
  • 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
  • Experimental: LPV/r 800/200 mg QD Tablet
    Intervention: Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
  • Experimental: LPV/r 800/200 mg QD SGC (Through Week 8)
    Intervention: Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
  • Active Comparator: LPV/r 400/100 mg BID Tablet
    Intervention: Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
  • Active Comparator: LPV/r 400/100 mg BID SGC (Through Week 8)
    Intervention: Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
664
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Greece,   Ireland,   Italy,   Netherlands,   Poland,   Puerto Rico,   Russian Federation,   Singapore,   Spain,   Switzerland,   Taiwan,   United Kingdom
 
NCT00262522
M05-730, 2005-001430-32
No
Abbott
Abbott
Not Provided
Study Director: Daniel E Cohen, MD Abbott
Abbott
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP