Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use (KaleEAST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01379703
First received: June 22, 2011
Last updated: October 10, 2011
Last verified: October 2011
Results First Received: August 9, 2011  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: HIV-1 Patients

  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
The study was carried out in two parts. The first part was initiated in 2004 with the lopinavir/ritonavir capsule formulation (Part I) and the second part (Part II) started in 2006 after the tablet formulation became available in participating countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tablets and Capsules or Oral Solution HIV-1 infected participants who received both tablet and capsule formulations or oral solution.
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Participant Flow for 2 periods

Period 1:   Study Start Through 9 Months
    Tablets and Capsules or Oral Solution     Capsule Formulation     Tablet Formulation  
STARTED     66 [1]   1206 [2]   1016 [3]
COMPLETED     62     1084 [4]   873  
NOT COMPLETED     4     122     143  
Lost to Follow-up                 2                 61                 104  
Adverse Event                 0                 14                 10  
Withdrawal by Subject                 0                 6                 1  
Treatment Failure                 0                 2                 2  
Patient Noncompliance                 0                 0                 1  
Tuberculosis/TB treatment                 0                 4                 0  
Medication not available                 0                 2                 1  
Poor general condition                 0                 1                 0  
Increased triglycerides                 0                 1                 0  
Reason unknown                 2                 31                 24  
[1] Participants taking lopinavir/ritonavir tablets/capsules or oral solution during the study (66/2288)
[2] Participants taking the lopinavir/ritonavir capsule formulation (only) during study (1206/2288)
[3] Participants taking the lopinavir/ritonavir tablet formulation (only) during study (1016/2288)
[4] Participants taking the capsule formulation were followed for an additional 9 months (up to 18 mos).

Period 2:   9 Months Through 18 Months
    Tablets and Capsules or Oral Solution     Capsule Formulation     Tablet Formulation  
STARTED     0 [1]   1084 [2]   0 [1]
COMPLETED     0     854     0  
NOT COMPLETED     0     230     0  
Lost to Follow-up                 0                 178                 0  
Withdrawal by Subject                 0                 11                 0  
Adverse Event                 0                 6                 0  
Treatment failure                 0                 5                 0  
Patient Noncompliance                 0                 4                 0  
Tuberculosis/TB treatment                 0                 2                 0  
Fatigue                 0                 1                 0  
Reason Unknown                 0                 23                 0  
[1] Participants in this subgroup were followed for 9 months.
[2] Participants taking the capsule formulation were followed for an additional 9 months (up to 18 mos).



  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
Total Study Population HIV-1 infected participants who received lopinavir/ritonavir (any formulation) during any part of the study.

Baseline Measures
    Total Study Population  
Number of Participants  
[units: participants]
  2288  
Age  
[units: years]
Mean ± Standard Deviation
  32.6  ± 11.0  
Gender, Customized  
[units: Participants]
 
Female     867  
Male     1419  
Data not reported     2  
Region of Enrollment  
[units: participants]
 
Serbia     149  
Czech Republic     107  
Slovenia     123  
Slovakia     26  
Poland     381  
Ukraine     266  
Romania     422  
Lithuania     3  
Russian Federation     644  
Israel     139  
Georgia     10  
Latvia     18  



  Outcome Measures
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1.  Primary:   CD4 Count   [ Time Frame: Baseline ]

Measure Type Primary
Measure Title CD4 Count
Measure Description CD4 lymphocyte count is a measure of a participant's immunologic health. Participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the number of CD4+ cells at baseline.
Time Frame Baseline  
Safety Issue No  

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.
Mean CD4 count is based on number of participants in each group who had CD4 count results at Baseline.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
    Total Study Population     Capsule Formulation     Tablet Formulation  
Number of Participants Analyzed  
[units: participants]
  2220     1165     993  
CD4 Count  
[units: cells per mm³]
Mean ± Standard Deviation
     
Mean CD4 count     229.9  ± 194.2     208.8  ± 187.2     246.8  ± 194.8  

No statistical analysis provided for CD4 Count



2.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 1 month ]

Measure Type Primary
Measure Title Changes in CD4 Count
Measure Description Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Time Frame Baseline to 1 month  
Safety Issue No  

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.
Change from baseline analysis is based on participants with CD4 count results available at 1 month.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
    Total Study Population     Capsule Formulation     Tablet Formulation  
Number of Participants Analyzed  
[units: participants]
  670     348     293  
Changes in CD4 Count  
[units: cells per mm³]
Mean ± Standard Deviation
     
Mean CD4 count at 1 month     288.7  ± 185.1     277.1  ± 195.7     296.1  ± 172.1  
Change in CD4 count     60.3  ± 137.4     54.9  ± 158.3     70.6  ± 113.8  

No statistical analysis provided for Changes in CD4 Count



3.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 3 months ]

Measure Type Primary
Measure Title Changes in CD4 Count
Measure Description Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Time Frame Baseline to 3 months  
Safety Issue No  

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.
Change from baseline analysis is based on participants with CD4 count results available at 3 months.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
    Total Study Population     Capsule Formulation     Tablet Formulation  
Number of Participants Analyzed  
[units: participants]
  1633     838     738  
Changes in CD4 Count  
[units: cells per mm³]
Mean ± Standard Deviation
     
Mean CD4 count at 3 months     323.9  ± 219.3     310.1  ± 227.9     332.4  ± 206.7  
Change in CD4 count     94.5  ± 162.9     97.7  ± 188.7     93.2  ± 123.9  

No statistical analysis provided for Changes in CD4 Count



4.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 6 months ]

Measure Type Primary
Measure Title Changes in CD4 Count
Measure Description Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Time Frame Baseline to 6 months  
Safety Issue No  

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.
Change from baseline analysis is based on participants with CD4 count results available at 6 months.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
    Total Study Population     Capsule Formulation     Tablet Formulation  
Number of Participants Analyzed  
[units: participants]
  1533     780     699  
Changes in CD4 Count  
[units: cells per mm³]
Mean ± Standard Deviation
     
Mean CD4 count at 6 months     361.5  ± 248.9     333.4  ± 219.8     382.0  ± 271.7  
Change in CD4 count     124.4  ± 197.6     117.1  ± 182.5     131.6  ± 216.0  

No statistical analysis provided for Changes in CD4 Count



5.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 9 months ]

Measure Type Primary
Measure Title Changes in CD4 Count
Measure Description Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Time Frame Baseline to 9 months  
Safety Issue No  

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.
Change from baseline analysis is based on participants with CD4 count results available at 9 months.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
    Total Study Population     Capsule Formulation     Tablet Formulation  
Number of Participants Analyzed  
[units: participants]
  1410     713     645  
Changes in CD4 Count  
[units: cells per mm³]
Mean ± Standard Deviation
     
Mean CD4 count at 9 months     384.1  ± 221.4     363.5  ± 222.2     395.0  ± 209.0  
Change in CD4 count     151.5  ± 174.4     144.8  ± 191.7     156.0  ± 151.5  

No statistical analysis provided for Changes in CD4 Count



6.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 12 months ]

Measure Type Primary
Measure Title Changes in CD4 Count
Measure Description Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Time Frame Baseline to 12 months  
Safety Issue No  

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.
Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on participants receiving capsule formulation with CD4 count results available at 12 months.

Reporting Groups
  Description
Capsule Formulation Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.

Measured Values
    Capsule Formulation  
Number of Participants Analyzed  
[units: participants]
  729  
Changes in CD4 Count  
[units: cells per mm³]
Mean ± Standard Deviation
 
Mean CD4 count at 12 months     392.0  ± 216.5  
Change in CD4 count     170.4  ± 201.7  

No statistical analysis provided for Changes in CD4 Count



7.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 15 months ]

Measure Type Primary
Measure Title Changes in CD4 Count
Measure Description Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Time Frame Baseline to 15 months  
Safety Issue No  

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.
Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on participants receiving capsule formulation with CD4 count results available at 15 months.

Reporting Groups
  Description
Capsule Formulation Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.

Measured Values
    Capsule Formulation  
Number of Participants Analyzed  
[units: participants]
  701  
Changes in CD4 Count  
[units: cells per mm³]
Mean ± Standard Deviation
 
Mean CD4 count at 15 months     412.6  ± 240.5  
Change in CD4 count     194.8  ± 228.5  

No statistical analysis provided for Changes in CD4 Count



8.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 18 months ]

Measure Type Primary
Measure Title Changes in CD4 Count
Measure Description Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Time Frame Baseline to 18 months  
Safety Issue No  

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.
Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on participants receiving capsule formulation with CD4 count results available at 18 months.

Reporting Groups
  Description
Capsule Formulation Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.

Measured Values
    Capsule Formulation  
Number of Participants Analyzed  
[units: participants]
  599  
Changes in CD4 Count  
[units: cells per mm³]
Mean ± Standard Deviation
 
Mean CD4 count at 18 months     429.7  ± 249.4  
Change in CD4 count     222.2  ± 228.7  

No statistical analysis provided for Changes in CD4 Count



9.  Primary:   Viral Load   [ Time Frame: Baseline ]

Measure Type Primary
Measure Title Viral Load
Measure Description Viral load is a direct measure of the viral burden by providing a count of the number of HIV-RNA copies in blood (plasma). The number of HIV-RNA copies in the blood was measured at baseline.
Time Frame Baseline  
Safety Issue No  

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.
Mean viral load is based on number of participants in each group who had laboratory results for viral load at baseline.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
    Total Study Population     Capsule Formulation     Tablet Formulation  
Number of Participants Analyzed  
[units: participants]
  1572     739     781  
Viral Load  
[units: Log10 copies per ml]
Mean ± Standard Deviation
     
Mean viral load     4.44  ± 1.26     4.49  ± 1.17     4.43  ± 1.31  

No statistical analysis provided for Viral Load



10.  Primary:   Viral Load   [ Time Frame: 1 month ]

Measure Type Primary
Measure Title Viral Load
Measure Description Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Time Frame 1 month  
Safety Issue No  

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
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
    Total Study Population     Capsule Formulation     Tablet Formulation  
Number of Participants Analyzed  
[units: participants]
  420     218     175  
Viral Load  
[units: Log10 copies per ml]
Mean ± Standard Deviation
  3.28  ± 1.08     3.42  ± 1.07     3.19  ± 1.04  

No statistical analysis provided for Viral Load



11.  Primary:   Viral Load   [ Time Frame: 3 months ]

Measure Type Primary
Measure Title Viral Load
Measure Description Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Time Frame 3 months  
Safety Issue No  

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
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
    Total Study Population     Capsule Formulation     Tablet Formulation  
Number of Participants Analyzed  
[units: participants]
  995     469     478  
Viral Load  
[units: Log10 copies per ml]
Mean ± Standard Deviation
  2.69  ± 1.00     2.86  ± 0.97     2.54  ± 1.00  

No statistical analysis provided for Viral Load



12.  Primary:   Viral Load   [ Time Frame: 6 months ]

Measure Type Primary
Measure Title Viral Load
Measure Description Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Time Frame 6 months  
Safety Issue No  

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
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
    Total Study Population     Capsule Formulation     Tablet Formulation  
Number of Participants Analyzed  
[units: participants]
  1093     506     544  
Viral Load  
[units: Log10 copies per ml]
Mean ± Standard Deviation
  2.40  ± 0.89     2.62  ± 0.88     2.21  ± 0.84  

No statistical analysis provided for Viral Load



13.  Primary:   Viral Load   [ Time Frame: 9 months ]

Measure Type Primary
Measure Title Viral Load
Measure Description Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Time Frame 9 months  
Safety Issue No  

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.
Change from baseline analysis is based on last observation carried forward for total study population (N=1341) and tablet formulation group (N=677).

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
    Total Study Population     Capsule Formulation     Tablet Formulation  
Number of Participants Analyzed  
[units: participants]
  918     406     471  
Viral Load  
[units: Log10 copies per ml]
Mean ± Standard Deviation
     
Mean viral load at 9 months     2.41  ± 0.96     2.65  ± 1.02     2.24  ± 0.88  
Change in viral load     -2.05  ± 1.42     NA  ± NA [1]   -2.21  ± 1.44  
[1] Change from baseline LOCF analysis for participants receiving capsule formulation was performed at 18 months.

No statistical analysis provided for Viral Load



14.  Primary:   Viral Load   [ Time Frame: 12 months ]

Measure Type Primary
Measure Title Viral Load
Measure Description Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Time Frame 12 months  
Safety Issue No  

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.
Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.

Reporting Groups
  Description
Capsule Formulation Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.

Measured Values
    Capsule Formulation  
Number of Participants Analyzed  
[units: participants]
  444  
Viral Load  
[units: Log10 copies per ml]
Mean ± Standard Deviation
  2.54  ± 0.92  

No statistical analysis provided for Viral Load



15.  Primary:   Viral Load   [ Time Frame: 15 months ]

Measure Type Primary
Measure Title Viral Load
Measure Description Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Time Frame 15 months  
Safety Issue No  

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.
Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.

Reporting Groups
  Description
Capsule Formulation Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.

Measured Values
    Capsule Formulation  
Number of Participants Analyzed  
[units: participants]
  432  
Viral Load  
[units: Log10 copies per ml]
Mean ± Standard Deviation
  2.49  ± 0.92  

No statistical analysis provided for Viral Load



16.  Primary:   Viral Load   [ Time Frame: 18 months ]

Measure Type Primary
Measure Title Viral Load
Measure Description Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Time Frame 18 months  
Safety Issue No  

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.
Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on last observation carried forward (N=660).

Reporting Groups
  Description
Capsule Formulation Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.

Measured Values
    Capsule Formulation  
Number of Participants Analyzed  
[units: participants]
  413  
Viral Load  
[units: Log10 copies per ml]
Mean ± Standard Deviation
 
Mean viral load at 18 months     2.35  ± 0.84  
Change in viral load     -1.95  ± 1.42  

No statistical analysis provided for Viral Load



17.  Primary:   Laboratory Parameter Blood Glucose   [ Time Frame: Baseline, 9 months, 18 months ]

Measure Type Primary
Measure Title Laboratory Parameter Blood Glucose
Measure Description Blood glucose laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.
Time Frame Baseline, 9 months, 18 months  
Safety Issue No  

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.
Analysis was based on participants with laboratory values at each time point. Only participants receiving lopinavir/ritonavir capsules were planned to be followed after 9 months.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
    Total Study Population     Capsule Formulation     Tablet Formulation  
Number of Participants Analyzed  
[units: participants]
  1831     875     899  
Laboratory Parameter Blood Glucose  
[units: millimoles per liter]
Mean ± Standard Deviation
     
Baseline     4.87  ± 2.05     4.89  ± 2.83     4.85  ± 0.86  
9 months     4.92  ± 1.42     4.87  ± 1.38     4.99  ± 1.49  
18 months     NA  ± NA [1]   5.07  ± 2.64     NA  ± NA [1]
[1] Only participants who received lopinavir/ritonavir capsules were planned to be followed past 9 months.

No statistical analysis provided for Laboratory Parameter Blood Glucose



18.  Primary:   Laboratory Parameter Transaminases   [ Time Frame: Baseline, 9 months, 18 months ]

Measure Type Primary
Measure Title Laboratory Parameter Transaminases
Measure Description Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.
Time Frame Baseline, 9 months, 18 months  
Safety Issue No  

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.
Analysis was based on participants with laboratory values at each time point. Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
    Total Study Population     Capsule Formulation     Tablet Formulation  
Number of Participants Analyzed  
[units: participants]
  2288     1206     1016  
Laboratory Parameter Transaminases  
[units: international units per liter]
Mean ± Standard Deviation
     
AST - Baseline     38.9  ± 37.1     36.8  ± 32.1     41.4  ± 42.4  
AST - 9 months     35.2  ± 33.0     34.8  ± 29.6     36.0  ± 36.9  
AST - 18 months     NA  ± NA [1]   36.4  ± 30.8     NA  ± NA [1]
ALT - Baseline     41.0  ± 40.3     39.6  ± 38.7     42.6  ± 42.6  
ALT - 9 months     39.8  ± 52.5     40.8  ± 44.8     39.0  ± 60.3  
ALT - 18 months     NA  ± NA [1]   42.0  ± 44.8     NA  ± NA [1]
[1] Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.

No statistical analysis provided for Laboratory Parameter Transaminases



19.  Primary:   Laboratory Parameter Lipids   [ Time Frame: Baseline, 9 months, 18 months ]

Measure Type Primary
Measure Title Laboratory Parameter Lipids
Measure Description A blood lipid panel consisting of total cholesterol, triglyceride, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) levels was performed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.
Time Frame Baseline, 9 months, 18 months  
Safety Issue No  

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.
Analysis was based on participants with laboratory values at each time point. Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
    Total Study Population     Capsule Formulation     Tablet Formulation  
Number of Participants Analyzed  
[units: participants]
  2288     1206     1016  
Laboratory Parameter Lipids  
[units: millimoles per liter]
Mean ± Standard Deviation
     
Total Cholesterol - Baseline     4.37  ± 1.50     4.48  ± 1.68     4.28  ± 1.35  
Total Cholesterol - 9 months     4.96  ± 1.81     5.07  ± 2.36     4.89  ± 1.25  
Total Cholesterol - 18 Months     NA  ± NA [1]   5.01  ± 1.29     NA  ± NA [1]
HDL Cholesterol - Baseline     1.39  ± 0.84     2.17  ± 1.45     1.19  ± 0.44  
HDL Cholesterol - 9 months     1.53  ± 0.98     2.08  ± 1.64     1.32  ± 0.53  
HDL Cholesterol - 18 months     NA  ± NA [1]   2.04  ± 1.94     NA  ± NA [1]
LDL Cholesterol - Baseline     2.50  ± 1.07     2.87  ± 1.10     2.29  ± 1.02  
LDL Cholesterol - 9 months     2.73  ± 1.07     3.11  ± 1.18     2.51  ± 0.95  
LDL Cholesterol - 18 months     NA  ± NA [1]   3.09  ± 1.14     NA  ± NA [1]
Triglycerides - Baseline     1.65  ± 1.06     1.66  ± 1.11     1.64  ± 1.04  
Triglycerides - 9 months     2.20  ± 1.46     2.21  ± 1.49     2.17  ± 1.44  
Triglycerides - 18 months     NA  ± NA [1]   2.13  ± 1.35     NA  ± NA [1]
[1] Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.

No statistical analysis provided for Laboratory Parameter Lipids



20.  Secondary:   Reasons for Discontinuation of Lopinavir/Ritonavir   [ Time Frame: 9 months ]

Measure Type Secondary
Measure Title Reasons for Discontinuation of Lopinavir/Ritonavir
Measure Description For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
Time Frame 9 months  
Safety Issue No  

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
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
    Total Study Population     Capsule Formulation     Tablet Formulation  
Number of Participants Analyzed  
[units: participants]
  2288     1206     1016  
Reasons for Discontinuation of Lopinavir/Ritonavir  
[units: Participants]
     
Number of participants discontinued     269     122     143  
Lost to Follow-up     167     61     104  
Adverse Event     24     14     10  
Withdrawal by Subject     7     6     1  
Treatment failure     4     2     2  
Other - Tuberculosis/TB treatment     4     4     0  
Other - Medication not available     3     2     1  
Other - Poor general condition     1     1     0  
Other - Increased triglycerides     1     1     0  
Patient Noncompliance     1     0     1  
Reason unknown     57     31     24  

No statistical analysis provided for Reasons for Discontinuation of Lopinavir/Ritonavir



21.  Secondary:   Reasons for Discontinuation of Lopinavir/Ritonavir   [ Time Frame: 18 months ]

Measure Type Secondary
Measure Title Reasons for Discontinuation of Lopinavir/Ritonavir
Measure Description For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
Time Frame 18 months  
Safety Issue No  

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.
Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.

Reporting Groups
  Description
Capsule Formulation Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.

Measured Values
    Capsule Formulation  
Number of Participants Analyzed  
[units: participants]
  1206  
Reasons for Discontinuation of Lopinavir/Ritonavir  
[units: Participants]
 
Number of participants discontinued     352  
Lost to Follow-up     239  
Adverse Event     20  
Withdrawal by Subject     17  
Treatment failure     7  
Other - Tuberculosis/TB treatment     6  
Patient Noncompliance     4  
Other - Medication not available     3  
Other - Fatigue     1  
Other - Increased triglycerides     1  
Reason unknown     54  

No statistical analysis provided for Reasons for Discontinuation of Lopinavir/Ritonavir



22.  Secondary:   Compliance With Lopinavir/Ritonavir   [ Time Frame: 9 months ]

Measure Type Secondary
Measure Title Compliance With Lopinavir/Ritonavir
Measure Description Participants reported whether they had missed doses of their antiretroviral treatment.
Time Frame 9 months  
Safety Issue No  

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
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
    Total Study Population     Capsule Formulation     Tablet Formulation  
Number of Participants Analyzed  
[units: participants]
  2288     1206     1016  
Compliance With Lopinavir/Ritonavir  
[units: Participants]
     
Reported never missing a dose     1377     729     616  
Reported missing one or more doses     853     459     361  
Information not reported     58     18     39  

No statistical analysis provided for Compliance With Lopinavir/Ritonavir



23.  Secondary:   Compliance With Lopinavir/Ritonavir   [ Time Frame: 18 months ]

Measure Type Secondary
Measure Title Compliance With Lopinavir/Ritonavir
Measure Description Participants reported whether they had missed any doses of their antiretroviral treatment.
Time Frame 18 months  
Safety Issue No  

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.
Only participants receiving lopinavir/ritonavir capsules for followed for up to 18 months.

Reporting Groups
  Description
Capsule Formulation Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.

Measured Values
    Capsule Formulation  
Number of Participants Analyzed  
[units: participants]
  1206  
Compliance With Lopinavir/Ritonavir  
[units: Participants]
 
Reported never missing a dose     616  
Reported missing one or more doses     578  
Information not reported     12  

No statistical analysis provided for Compliance With Lopinavir/Ritonavir



24.  Secondary:   Adverse Events Observed on Treatment With Lopinavir/Ritonavir.   [ Time Frame: 18 months ]

Measure Type Secondary
Measure Title Adverse Events Observed on Treatment With Lopinavir/Ritonavir.
Measure Description

Total number of adverse events with causal relationship (rated by Investigator as probably or possibly related) to lopinavir/ritonavir treatment.

All serious adverse events and non serious adverse events (0.2% or greater frequency) are summarized in the "Reported Adverse Events" section of this record.

Time Frame 18 months  
Safety Issue No  

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
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
    Total Study Population     Capsule Formulation     Tablet Formulation  
Number of Participants Analyzed  
[units: participants]
  2288     1206     1016  
Adverse Events Observed on Treatment With Lopinavir/Ritonavir.  
[units: Events]
     
Total number of AEs with causal relationship     260     175     78  

No statistical analysis provided for Adverse Events Observed on Treatment With Lopinavir/Ritonavir.




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: Abbott
phone: 1-800-633-9110


No publications provided


Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01379703     History of Changes
Other Study ID Numbers: PMOS-EAST-04-1
Study First Received: June 22, 2011
Results First Received: August 9, 2011
Last Updated: October 10, 2011
Health Authority: Romania: Ethics Committee
Romania: National Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Serbia: Ethics Committee
Israel: Ethics Commission
Israel: Ministry of Health
Slovenia: Ethics Committee
Slovak Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Latvia: Institutional Review Board
Latvia: State Agency of Medicines
Lithuania: Bioethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health