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

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ClinicalTrials.gov Identifier: NCT01379703
Recruitment Status : Completed
First Posted : June 23, 2011
Results First Posted : September 12, 2011
Last Update Posted : October 17, 2011
Sponsor:
Information provided by (Responsible Party):
Abbott

Study Type Observational
Study Design Time Perspective: Prospective
Condition HIV-1 Patients
Enrollment 2288
Recruitment Details 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  
Arm/Group Title Tablets and Capsules or Oral Solution Capsule Formulation Tablet Formulation
Hide Arm/Group Description HIV-1 infected participants who received both tablet and capsule formulations or oral solution. Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study. Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Period Title: Study Start Through 9 Months
Started 66 [1] 1206 [2] 1016 [3]
Completed 62 1084 [4] 873
Not Completed 4 122 143
Reason Not Completed
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 Title: 9 Months Through 18 Months
Started 0 [1] 1084 [2] 0 [1]
Completed 0 854 0
Not Completed 0 230 0
Reason Not Completed
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).
Arm/Group Title Total Study Population
Hide Arm/Group Description HIV-1 infected participants who received lopinavir/ritonavir (any formulation) during any part of the study.
Overall Number of Baseline Participants 2288
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2288 participants
32.6  (11.0)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2288 participants
Female 867
Male 1419
Data not reported 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2288 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
1.Primary Outcome
Title CD4 Count
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Mean CD4 count is based on number of participants in each group who had CD4 count results at Baseline.
Arm/Group Title Total Study Population Capsule Formulation Tablet Formulation
Hide Arm/Group Description:
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).
Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Overall Number of Participants Analyzed 2220 1165 993
Mean (Standard Deviation)
Unit of Measure: cells per mm³
Mean CD4 count 229.9  (194.2) 208.8  (187.2) 246.8  (194.8)
2.Primary Outcome
Title Changes in CD4 Count
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Change from baseline analysis is based on participants with CD4 count results available at 1 month.
Arm/Group Title Total Study Population Capsule Formulation Tablet Formulation
Hide Arm/Group Description:
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).
Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Overall Number of Participants Analyzed 670 348 293
Mean (Standard Deviation)
Unit of Measure: cells per mm³
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)
3.Primary Outcome
Title Changes in CD4 Count
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Change from baseline analysis is based on participants with CD4 count results available at 3 months.
Arm/Group Title Total Study Population Capsule Formulation Tablet Formulation
Hide Arm/Group Description:
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).
Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Overall Number of Participants Analyzed 1633 838 738
Mean (Standard Deviation)
Unit of Measure: cells per mm³
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)
4.Primary Outcome
Title Changes in CD4 Count
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Change from baseline analysis is based on participants with CD4 count results available at 6 months.
Arm/Group Title Total Study Population Capsule Formulation Tablet Formulation
Hide Arm/Group Description:
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).
Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Overall Number of Participants Analyzed 1533 780 699
Mean (Standard Deviation)
Unit of Measure: cells per mm³
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)
5.Primary Outcome
Title Changes in CD4 Count
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Change from baseline analysis is based on participants with CD4 count results available at 9 months.
Arm/Group Title Total Study Population Capsule Formulation Tablet Formulation
Hide Arm/Group Description:
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).
Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Overall Number of Participants Analyzed 1410 713 645
Mean (Standard Deviation)
Unit of Measure: cells per mm³
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)
6.Primary Outcome
Title Changes in CD4 Count
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Capsule Formulation
Hide Arm/Group Description:
Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
Overall Number of Participants Analyzed 729
Mean (Standard Deviation)
Unit of Measure: cells per mm³
Mean CD4 count at 12 months 392.0  (216.5)
Change in CD4 count 170.4  (201.7)
7.Primary Outcome
Title Changes in CD4 Count
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Capsule Formulation
Hide Arm/Group Description:
Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
Overall Number of Participants Analyzed 701
Mean (Standard Deviation)
Unit of Measure: cells per mm³
Mean CD4 count at 15 months 412.6  (240.5)
Change in CD4 count 194.8  (228.5)
8.Primary Outcome
Title Changes in CD4 Count
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Capsule Formulation
Hide Arm/Group Description:
Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
Overall Number of Participants Analyzed 599
Mean (Standard Deviation)
Unit of Measure: cells per mm³
Mean CD4 count at 18 months 429.7  (249.4)
Change in CD4 count 222.2  (228.7)
9.Primary Outcome
Title Viral Load
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Mean viral load is based on number of participants in each group who had laboratory results for viral load at baseline.
Arm/Group Title Total Study Population Capsule Formulation Tablet Formulation
Hide Arm/Group Description:
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).
Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Overall Number of Participants Analyzed 1572 739 781
Mean (Standard Deviation)
Unit of Measure: Log10 copies per ml
Mean viral load 4.44  (1.26) 4.49  (1.17) 4.43  (1.31)
10.Primary Outcome
Title Viral Load
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Study Population Capsule Formulation Tablet Formulation
Hide Arm/Group Description:
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).
Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Overall Number of Participants Analyzed 420 218 175
Mean (Standard Deviation)
Unit of Measure: Log10 copies per ml
3.28  (1.08) 3.42  (1.07) 3.19  (1.04)
11.Primary Outcome
Title Viral Load
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Study Population Capsule Formulation Tablet Formulation
Hide Arm/Group Description:
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).
Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Overall Number of Participants Analyzed 995 469 478
Mean (Standard Deviation)
Unit of Measure: Log10 copies per ml
2.69  (1.00) 2.86  (0.97) 2.54  (1.00)
12.Primary Outcome
Title Viral Load
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Study Population Capsule Formulation Tablet Formulation
Hide Arm/Group Description:
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).
Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Overall Number of Participants Analyzed 1093 506 544
Mean (Standard Deviation)
Unit of Measure: Log10 copies per ml
2.40  (0.89) 2.62  (0.88) 2.21  (0.84)
13.Primary Outcome
Title Viral Load
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Change from baseline analysis is based on last observation carried forward for total study population (N=1341) and tablet formulation group (N=677).
Arm/Group Title Total Study Population Capsule Formulation Tablet Formulation
Hide Arm/Group Description:
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).
Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Overall Number of Participants Analyzed 918 406 471
Mean (Standard Deviation)
Unit of Measure: Log10 copies per ml
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 [1]   (NA) -2.21  (1.44)
[1]
Change from baseline LOCF analysis for participants receiving capsule formulation was performed at 18 months.
14.Primary Outcome
Title Viral Load
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.
Arm/Group Title Capsule Formulation
Hide Arm/Group Description:
Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
Overall Number of Participants Analyzed 444
Mean (Standard Deviation)
Unit of Measure: Log10 copies per ml
2.54  (0.92)
15.Primary Outcome
Title Viral Load
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.
Arm/Group Title Capsule Formulation
Hide Arm/Group Description:
Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
Overall Number of Participants Analyzed 432
Mean (Standard Deviation)
Unit of Measure: Log10 copies per ml
2.49  (0.92)
16.Primary Outcome
Title Viral Load
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Capsule Formulation
Hide Arm/Group Description:
Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
Overall Number of Participants Analyzed 413
Mean (Standard Deviation)
Unit of Measure: Log10 copies per ml
Mean viral load at 18 months 2.35  (0.84)
Change in viral load -1.95  (1.42)
17.Primary Outcome
Title Laboratory Parameter Blood Glucose
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Total Study Population Capsule Formulation Tablet Formulation
Hide Arm/Group Description:
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).
Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Overall Number of Participants Analyzed 1831 875 899
Mean (Standard Deviation)
Unit of Measure: millimoles per liter
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 [1]   (NA) 5.07  (2.64) NA [1]   (NA)
[1]
Only participants who received lopinavir/ritonavir capsules were planned to be followed past 9 months.
18.Primary Outcome
Title Laboratory Parameter Transaminases
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Total Study Population Capsule Formulation Tablet Formulation
Hide Arm/Group Description:
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).
Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Overall Number of Participants Analyzed 2288 1206 1016
Mean (Standard Deviation)
Unit of Measure: international units per liter
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 [1]   (NA) 36.4  (30.8) NA [1]   (NA)
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 [1]   (NA) 42.0  (44.8) NA [1]   (NA)
[1]
Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.
19.Primary Outcome
Title Laboratory Parameter Lipids
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Total Study Population Capsule Formulation Tablet Formulation
Hide Arm/Group Description:
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).
Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Overall Number of Participants Analyzed 2288 1206 1016
Mean (Standard Deviation)
Unit of Measure: millimoles per liter
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 [1]   (NA) 5.01  (1.29) NA [1]   (NA)
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 [1]   (NA) 2.04  (1.94) NA [1]   (NA)
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 [1]   (NA) 3.09  (1.14) NA [1]   (NA)
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 [1]   (NA) 2.13  (1.35) NA [1]   (NA)
[1]
Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.
20.Secondary Outcome
Title Reasons for Discontinuation of Lopinavir/Ritonavir
Hide Description For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
Time Frame 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Study Population Capsule Formulation Tablet Formulation
Hide Arm/Group Description:
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).
Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Overall Number of Participants Analyzed 2288 1206 1016
Measure Type: Number
Unit of Measure: 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
21.Secondary Outcome
Title Reasons for Discontinuation of Lopinavir/Ritonavir
Hide Description For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.
Arm/Group Title Capsule Formulation
Hide Arm/Group Description:
Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
Overall Number of Participants Analyzed 1206
Measure Type: Number
Unit of Measure: 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
22.Secondary Outcome
Title Compliance With Lopinavir/Ritonavir
Hide Description Participants reported whether they had missed doses of their antiretroviral treatment.
Time Frame 9 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Study Population Capsule Formulation Tablet Formulation
Hide Arm/Group Description:
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).
Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Overall Number of Participants Analyzed 2288 1206 1016
Measure Type: Number
Unit of Measure: Participants
Reported never missing a dose 1377 729 616
Reported missing one or more doses 853 459 361
Information not reported 58 18 39
23.Secondary Outcome
Title Compliance With Lopinavir/Ritonavir
Hide Description Participants reported whether they had missed any doses of their antiretroviral treatment.
Time Frame 18 months
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Hide Analysis Population Description
Only participants receiving lopinavir/ritonavir capsules for followed for up to 18 months.
Arm/Group Title Capsule Formulation
Hide Arm/Group Description:
Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
Overall Number of Participants Analyzed 1206
Measure Type: Number
Unit of Measure: Participants
Reported never missing a dose 616
Reported missing one or more doses 578
Information not reported 12
24.Secondary Outcome
Title Adverse Events Observed on Treatment With Lopinavir/Ritonavir.
Hide 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
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Study Population Capsule Formulation Tablet Formulation
Hide Arm/Group Description:
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).
Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Overall Number of Participants Analyzed 2288 1206 1016
Measure Type: Number
Unit of Measure: Events
Total number of AEs with causal relationship 260 175 78
Time Frame Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules.
Adverse Event Reporting Description Adverse events (AEs) and Serious AEs occurring during the study were recorded. Serious AEs were reported from the time the physician obtained the patient's authorization to use and disclose information (or the patient's informed consent) until 30 days following intake of the last dose of the physician-prescribed lopinavir/ritonavir treatment.
 
Arm/Group Title Total Study Population Capsule Formulation Tablet Formulation
Hide Arm/Group Description 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). Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study. Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
All-Cause Mortality
Total Study Population Capsule Formulation Tablet Formulation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Total Study Population Capsule Formulation Tablet Formulation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   46/2288 (2.01%)   22/1206 (1.82%)   22/1016 (2.17%) 
Blood and lymphatic system disorders       
Anaemia  1  3/2288 (0.13%)  2/1206 (0.17%)  1/1016 (0.10%) 
Haemolytic anaemia  1  1/2288 (0.04%)  0/1206 (0.00%)  1/1016 (0.10%) 
Lymphadenopathy  1  1/2288 (0.04%)  1/1206 (0.08%)  0/1016 (0.00%) 
Thrombocytopenia  1  2/2288 (0.09%)  1/1206 (0.08%)  1/1016 (0.10%) 
Eye disorders       
Exophthalmos  1  1/2288 (0.04%)  1/1206 (0.08%)  0/1016 (0.00%) 
Iridocyclitis  1  2/2288 (0.09%)  0/1206 (0.00%)  2/1016 (0.20%) 
Mydriasis  1  1/2288 (0.04%)  1/1206 (0.08%)  0/1016 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  1/2288 (0.04%)  1/1206 (0.08%)  0/1016 (0.00%) 
Diarrhoea  1  4/2288 (0.17%)  1/1206 (0.08%)  3/1016 (0.30%) 
Vomiting  1  1/2288 (0.04%)  0/1206 (0.00%)  1/1016 (0.10%) 
General disorders       
Asthenia  1  1/2288 (0.04%)  1/1206 (0.08%)  0/1016 (0.00%) 
Chest pain  1  1/2288 (0.04%)  0/1206 (0.00%)  1/1016 (0.10%) 
Death  1  7/2288 (0.31%)  2/1206 (0.17%)  5/1016 (0.49%) 
Fatigue  1  1/2288 (0.04%)  1/1206 (0.08%)  0/1016 (0.00%) 
Pyrexia  1  3/2288 (0.13%)  3/1206 (0.25%)  0/1016 (0.00%) 
Infections and infestations       
Acquired immunodeficiency syndrome  1  2/2288 (0.09%)  2/1206 (0.17%)  0/1016 (0.00%) 
Acute sinusitis  1  1/2288 (0.04%)  1/1206 (0.08%)  0/1016 (0.00%) 
Bronchitis  1  1/2288 (0.04%)  0/1206 (0.00%)  1/1016 (0.10%) 
Cellulitis  1  2/2288 (0.09%)  1/1206 (0.08%)  1/1016 (0.10%) 
Cerebral toxoplasmosis  1  2/2288 (0.09%)  0/1206 (0.00%)  2/1016 (0.20%) 
Encephalitis cytomegalovirus  1  1/2288 (0.04%)  0/1206 (0.00%)  1/1016 (0.10%) 
Hepatitis C  1  1/2288 (0.04%)  1/1206 (0.08%)  0/1016 (0.00%) 
Meningitis cryptococcal  1  1/2288 (0.04%)  1/1206 (0.08%)  0/1016 (0.00%) 
Mycobacterium avium complex infection  1  2/2288 (0.09%)  0/1206 (0.00%)  2/1016 (0.20%) 
Pharyngitis  1  1/2288 (0.04%)  1/1206 (0.08%)  0/1016 (0.00%) 
Pneumocystis jiroveci pneumonia  1  2/2288 (0.09%)  2/1206 (0.17%)  0/1016 (0.00%) 
Pneumonia  1  1/2288 (0.04%)  0/1206 (0.00%)  1/1016 (0.10%) 
Septic shock  1  1/2288 (0.04%)  0/1206 (0.00%)  1/1016 (0.10%) 
Tuberculosis  1  1/2288 (0.04%)  0/1206 (0.00%)  1/1016 (0.10%) 
Investigations       
Mycobacteria test  1  1/2288 (0.04%)  1/1206 (0.08%)  0/1016 (0.00%) 
Metabolism and nutrition disorders       
Cachexiae  1  1/2288 (0.04%)  1/1206 (0.08%)  0/1016 (0.00%) 
Diabetes mellitus  1  1/2288 (0.04%)  0/1206 (0.00%)  1/1016 (0.10%) 
Musculoskeletal and connective tissue disorders       
Musculoskeletal stiffness  1  1/2288 (0.04%)  1/1206 (0.08%)  0/1016 (0.00%) 
Synovitis  1  1/2288 (0.04%)  0/1206 (0.00%)  1/1016 (0.10%) 
Nervous system disorders       
Cerebral haemorrhage  1 [1]  1/2288 (0.04%)  0/1206 (0.00%)  0/1016 (0.00%) 
Headache  1  2/2288 (0.09%)  2/1206 (0.17%)  0/1016 (0.00%) 
Hypoaesthesia  1  1/2288 (0.04%)  1/1206 (0.08%)  0/1016 (0.00%) 
Neuralgia  1  1/2288 (0.04%)  0/1206 (0.00%)  1/1016 (0.10%) 
Psychiatric disorders       
Completed suicide  1  1/2288 (0.04%)  1/1206 (0.08%)  0/1016 (0.00%) 
Depression  1  1/2288 (0.04%)  1/1206 (0.08%)  0/1016 (0.00%) 
Disorientation  1  1/2288 (0.04%)  1/1206 (0.08%)  0/1016 (0.00%) 
Renal and urinary disorders       
Renal failure  1  1/2288 (0.04%)  0/1206 (0.00%)  1/1016 (0.10%) 
Renal failure acute  1  1/2288 (0.04%)  1/1206 (0.08%)  0/1016 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary oedema  1 [2]  2/2288 (0.09%)  0/1206 (0.00%)  1/1016 (0.10%) 
Skin and subcutaneous tissue disorders       
Toxic skin eruption  1  1/2288 (0.04%)  1/1206 (0.08%)  0/1016 (0.00%) 
Surgical and medical procedures       
Hospitalisation  1  1/2288 (0.04%)  0/1206 (0.00%)  1/1016 (0.10%) 
Thrombectomy  1  1/2288 (0.04%)  0/1206 (0.00%)  1/1016 (0.10%) 
Vascular disorders       
Deep vein thrombosis  1  1/2288 (0.04%)  0/1206 (0.00%)  1/1016 (0.10%) 
Venous thrombosis  1  1/2288 (0.04%)  1/1206 (0.08%)  0/1016 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
[1]
Adverse event occurred in one of the 66 participants receiving both capsules and tablets, or oral solution.
[2]
One of the two adverse events occurred in one of the 66 participants receiving both capsules and tablets, or oral solution.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.2%
Total Study Population Capsule Formulation Tablet Formulation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   109/2288 (4.76%)   77/1206 (6.38%)   34/1016 (3.35%) 
Blood and lymphatic system disorders       
Anaemia  1  4/2288 (0.17%)  3/1206 (0.25%)  1/1016 (0.10%) 
Gastrointestinal disorders       
Abdominal pain  1  5/2288 (0.22%)  2/1206 (0.17%)  3/1016 (0.30%) 
Abdominal pain upper  1  8/2288 (0.35%)  6/1206 (0.50%)  2/1016 (0.20%) 
Diarrhoea  1 [1]  67/2288 (2.93%)  43/1206 (3.57%)  21/1016 (2.07%) 
Flatulence  1  3/2288 (0.13%)  3/1206 (0.25%)  0/1016 (0.00%) 
Gastrointestinal disorder  1  4/2288 (0.17%)  1/1206 (0.08%)  3/1016 (0.30%) 
Nausea  1 [1]  38/2288 (1.66%)  30/1206 (2.49%)  7/1016 (0.69%) 
Vomiting  1 [1]  24/2288 (1.05%)  17/1206 (1.41%)  6/1016 (0.59%) 
General disorders       
Asthenia  1  10/2288 (0.44%)  6/1206 (0.50%)  4/1016 (0.39%) 
Fatigue  1 [1]  6/2288 (0.26%)  4/1206 (0.33%)  1/1016 (0.10%) 
Immune system disorders       
Drug hypersensitivity  1  3/2288 (0.13%)  3/1206 (0.25%)  0/1016 (0.00%) 
Investigations       
Weight decreased  1  3/2288 (0.13%)  3/1206 (0.25%)  0/1016 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite  1  4/2288 (0.17%)  3/1206 (0.25%)  1/1016 (0.10%) 
Hypertriglyceridaemia  1  6/2288 (0.26%)  5/1206 (0.41%)  1/1016 (0.10%) 
Nervous system disorders       
Headache  1  6/2288 (0.26%)  5/1206 (0.41%)  1/1016 (0.10%) 
Psychiatric disorders       
Depression  1  3/2288 (0.13%)  3/1206 (0.25%)  0/1016 (0.00%) 
Skin and subcutaneous tissue disorders       
Pruritus  1  5/2288 (0.22%)  4/1206 (0.33%)  1/1016 (0.10%) 
Rash  1  3/2288 (0.13%)  3/1206 (0.25%)  0/1016 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
[1]
One or more adverse events occurred in the 66 participants receiving both capsules and tablets, or oral solution.
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.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: Abbott
Phone: 1-800-633-9110
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01379703     History of Changes
Other Study ID Numbers: PMOS-EAST-04-1
First Submitted: June 22, 2011
First Posted: June 23, 2011
Results First Submitted: August 9, 2011
Results First Posted: September 12, 2011
Last Update Posted: October 17, 2011