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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:
ClinicalTrials.gov Identifier:
NCT00262522
First Posted: December 7, 2005
Last Update Posted: February 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Abbott
Results First Submitted: July 9, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Human Immunodeficiency Virus Infections
Intervention: Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled at 131 sites in 19 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 672 subjects randomized, 8 discontinued from the study prior to receiving study drug due to withdrawal of consent (3), acute illness (2), lost to follow-up (1), other (1), and required prohibited medication (1).

Reporting Groups
  Description
LPV/r 800/200 mg QD Tablet lopinavir/ritonavir 800/200 mg once daily (QD) tablet
LPV/r 800/200 mg QD SGC (Through Week 8) lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
LPV/r 400/100 mg BID Tablet lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
LPV/r 400/100 mg BID SGC (Through Week 8) lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)

Participant Flow for 3 periods

 Period 1:   Study Start Through 8 Weeks
    LPV/r 800/200 mg QD Tablet   LPV/r 800/200 mg QD SGC (Through Week 8)   LPV/r 400/100 mg BID Tablet   LPV/r 400/100 mg BID SGC (Through Week 8)
STARTED   167   166   166   165 
COMPLETED   163   161   155   160 
NOT COMPLETED   4   5   11   5 
Adverse Event                1                2                3                1 
Withdrawal by Subject                1                1                3                0 
Lost to Follow-up                1                2                3                2 
Noncompliance                0                0                2                2 
Death                1                0                0                0 

Period 2:   Study Start Through 48 Weeks
    LPV/r 800/200 mg QD Tablet   LPV/r 800/200 mg QD SGC (Through Week 8)   LPV/r 400/100 mg BID Tablet   LPV/r 400/100 mg BID SGC (Through Week 8)
STARTED   333 [1]   0 [2]   331 [1]   0 [3] 
COMPLETED   284   0   276   0 
NOT COMPLETED   49   0   55   0 
Adverse Event                16                0                10                0 
Withdrawal by Subject                10                0                11                0 
Lost to Follow-up                8                0                14                0 
Noncompliance                3                0                8                0 
Death                2                0                1                0 
Virologic failure                2                0                4                0 
Relocated, Needed to take twice daily                8                0                7                0 
[1] Number of subjects who started the study, not the number who completed the first 8 weeks.
[2] After Week 8, these subjects received the tablet formulation once daily through the end of study.
[3] After Week 8, these subjects received the tablet formulation twice daily through the end of study.

Period 3:   Study Start Through 96 Weeks
    LPV/r 800/200 mg QD Tablet   LPV/r 800/200 mg QD SGC (Through Week 8)   LPV/r 400/100 mg BID Tablet   LPV/r 400/100 mg BID SGC (Through Week 8)
STARTED   333 [1]   0 [2]   331 [1]   0 [3] 
COMPLETED   256   0   254   0 
NOT COMPLETED   77   0   77   0 
Adverse Event                20                0                16                0 
Withdrawal by Subject                15                0                13                0 
Lost to Follow-up                19                0                18                0 
Noncompliance                6                0                11                0 
Death                2                0                2                0 
Virologic failure                5                0                8                0 
Relocated, Needed to take twice daily                10                0                9                0 
[1] Number of subjects who started the study, not the number who completed the first 48 weeks.
[2] After Week 8, these subjects received the tablet formulation once daily through the end of study.
[3] After Week 8, these subjects received the tablet formulation twice daily through the end of study.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
LPV/r 800/200 mg QD Tablet lopinavir/ritonavir 800/200 mg once daily (QD) tablet
LPV/r 800/200 mg QD SGC (Through Week 8) lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
LPV/r 400/100 mg BID Tablet lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
LPV/r 400/100 mg BID SGC (Through Week 8) lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
Total Total of all reporting groups

Baseline Measures
   LPV/r 800/200 mg QD Tablet   LPV/r 800/200 mg QD SGC (Through Week 8)   LPV/r 400/100 mg BID Tablet   LPV/r 400/100 mg BID SGC (Through Week 8)   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 167   166   166   165   664 
Age 
[Units: Years]
Mean (Standard Deviation) 		 38.7  (9.80)   38.2  (9.63)   38.3  (9.69)   39.5  (10.31)   38.7  (9.85) 
Gender 
[Units: Participants]
 		         
Female   36   31   39   38   144 
Male   131   135   127   127   520 
CD4+ T Cell Count [1] 
[Units: Cells/mm3]
Mean (Standard Deviation) 		 209.9  (125.10)   222.6  (127.37)   226.4  (136.64)   202.9  (139.57)   215.5  (132.34) 
[1] For once daily (QD) soft gel capsule (SGC), N=165.
Plasma HIV-1 RNA Level 
[Units: Log10 copies/mL]
Mean (Standard Deviation) 		 4.92  (0.64)   4.94  (0.67)   5.04  (0.68)   5.06  (0.64)   4.99  (0.66) 


  Outcome Measures
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1.  Primary:   Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks   [ Time Frame: Week 8 ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks
Measure Description No text entered.
Time Frame Week 8  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized subjects who received at least 1 dose of study drug.

Reporting Groups
  Description
LPV/r 800/200 mg QD Tablet lopinavir/ritonavir 800/200 mg once daily (QD) tablet
LPV/r 800/200 mg QD SGC (Through Week 8) lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
LPV/r 400/100 mg BID Tablet lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
LPV/r 400/100 mg BID SGC (Through Week 8) lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)

Measured Values
   LPV/r 800/200 mg QD Tablet   LPV/r 800/200 mg QD SGC (Through Week 8)   LPV/r 400/100 mg BID Tablet   LPV/r 400/100 mg BID SGC (Through Week 8) 
Participants Analyzed 
[Units: Participants]
 		 167   166   166   165 
Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks 
[Units: Percentage of Subjects]
 		 49.1   54.8   44.6   49.7 


Statistical Analysis 1 for Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Cochran-Mantel-Haenszel
P Value [4] >0.100
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Cochran-Mantel-Haenszel (CMH) test stratified by dosing regimen was used to assess the null hypothesis of no difference between the tablet and soft gel capsule (SGC). Sample size was 600 subjects (150 each in the 4 groups). Based on a projected 48% reporting treatment-emergent diarrhea in the QD arm and 32% in the BID arm within the SGC group, with a 12% reduction in the corresponding tablet groups, this sample size provided 80% power to determine a difference between the tablet and SGC.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



2.  Primary:   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 ]
  Show Outcome Measure 2

3.  Secondary:   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) ]
  Show Outcome Measure 3

4.  Secondary:   Mean Change From Baseline to Week 96 in CD4+ T Cell Counts   [ Time Frame: Week 96 (End of Study) ]
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  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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