Trial Outcomes & Findings for Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use (NCT NCT01379703)

NCT ID: NCT01379703

Last Updated: 2011-10-17

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 2288 participants
• Primary outcome timeframe: Baseline, 9 months, 18 months
• Results posted on: 2011-10-17

Participant Flow

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.

Participant milestones

Measure	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.
Study Start Through 9 Months STARTED	66	1206	1016
Study Start Through 9 Months COMPLETED	62	1084	873
Study Start Through 9 Months NOT COMPLETED	4	122	143
9 Months Through 18 Months STARTED	0	1084	0
9 Months Through 18 Months COMPLETED	0	854	0
9 Months Through 18 Months NOT COMPLETED	0	230	0

Reasons for withdrawal

Measure	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.
Study Start Through 9 Months Lost to Follow-up	2	61	104
Study Start Through 9 Months Adverse Event	0	14	10
Study Start Through 9 Months Withdrawal by Subject	0	6	1
Study Start Through 9 Months Treatment Failure	0	2	2
Study Start Through 9 Months Patient Noncompliance	0	0	1
Study Start Through 9 Months Tuberculosis/TB treatment	0	4	0
Study Start Through 9 Months Medication not available	0	2	1
Study Start Through 9 Months Poor general condition	0	1	0
Study Start Through 9 Months Increased triglycerides	0	1	0
Study Start Through 9 Months Reason unknown	2	31	24
9 Months Through 18 Months Lost to Follow-up	0	178	0
9 Months Through 18 Months Withdrawal by Subject	0	11	0
9 Months Through 18 Months Adverse Event	0	6	0
9 Months Through 18 Months Treatment failure	0	5	0
9 Months Through 18 Months Patient Noncompliance	0	4	0
9 Months Through 18 Months Tuberculosis/TB treatment	0	2	0
9 Months Through 18 Months Fatigue	0	1	0
9 Months Through 18 Months Reason Unknown	0	23	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Total Study Population n=2288 Participants HIV-1 infected participants who received lopinavir/ritonavir (any formulation) during any part of the study.
Age Continuous	32.6 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex/Gender, Customized Female	867 Participants n=5 Participants
Sex/Gender, Customized Male	1419 Participants n=5 Participants
Sex/Gender, Customized Data not reported	2 Participants n=5 Participants
Region of Enrollment Serbia	149 participants n=5 Participants
Region of Enrollment Czech Republic	107 participants n=5 Participants
Region of Enrollment Slovenia	123 participants n=5 Participants
Region of Enrollment Slovakia	26 participants n=5 Participants
Region of Enrollment Poland	381 participants n=5 Participants
Region of Enrollment Ukraine	266 participants n=5 Participants
Region of Enrollment Romania	422 participants n=5 Participants
Region of Enrollment Lithuania	3 participants n=5 Participants
Region of Enrollment Russian Federation	644 participants n=5 Participants
Region of Enrollment Israel	139 participants n=5 Participants
Region of Enrollment Georgia	10 participants n=5 Participants
Region of Enrollment Latvia	18 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

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

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.

Outcome measures

Measure	Total Study Population n=2220 Participants 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 n=1165 Participants Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.	Tablet Formulation n=993 Participants Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
CD4 Count Mean CD4 count	229.9 cells per mm³ Standard Deviation 194.2	208.8 cells per mm³ Standard Deviation 187.2	246.8 cells per mm³ Standard Deviation 194.8

PRIMARY outcome

Timeframe: Baseline to 1 month

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

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.

Outcome measures

Measure	Total Study Population n=670 Participants 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 n=348 Participants Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.	Tablet Formulation n=293 Participants Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Changes in CD4 Count Mean CD4 count at 1 month	288.7 cells per mm³ Standard Deviation 185.1	277.1 cells per mm³ Standard Deviation 195.7	296.1 cells per mm³ Standard Deviation 172.1
Changes in CD4 Count Change in CD4 count	60.3 cells per mm³ Standard Deviation 137.4	54.9 cells per mm³ Standard Deviation 158.3	70.6 cells per mm³ Standard Deviation 113.8

PRIMARY outcome

Timeframe: Baseline to 3 months

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

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.

Outcome measures

Measure	Total Study Population n=1633 Participants 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 n=838 Participants Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.	Tablet Formulation n=738 Participants Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Changes in CD4 Count Mean CD4 count at 3 months	323.9 cells per mm³ Standard Deviation 219.3	310.1 cells per mm³ Standard Deviation 227.9	332.4 cells per mm³ Standard Deviation 206.7
Changes in CD4 Count Change in CD4 count	94.5 cells per mm³ Standard Deviation 162.9	97.7 cells per mm³ Standard Deviation 188.7	93.2 cells per mm³ Standard Deviation 123.9

PRIMARY outcome

Timeframe: Baseline to 6 months

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

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.

Outcome measures

Measure	Total Study Population n=1533 Participants 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 n=780 Participants Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.	Tablet Formulation n=699 Participants Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Changes in CD4 Count Mean CD4 count at 6 months	361.5 cells per mm³ Standard Deviation 248.9	333.4 cells per mm³ Standard Deviation 219.8	382.0 cells per mm³ Standard Deviation 271.7
Changes in CD4 Count Change in CD4 count	124.4 cells per mm³ Standard Deviation 197.6	117.1 cells per mm³ Standard Deviation 182.5	131.6 cells per mm³ Standard Deviation 216.0

PRIMARY outcome

Timeframe: Baseline to 9 months

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

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.

Outcome measures

Measure	Total Study Population n=1410 Participants 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 n=713 Participants Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.	Tablet Formulation n=645 Participants Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Changes in CD4 Count Mean CD4 count at 9 months	384.1 cells per mm³ Standard Deviation 221.4	363.5 cells per mm³ Standard Deviation 222.2	395.0 cells per mm³ Standard Deviation 209.0
Changes in CD4 Count Change in CD4 count	151.5 cells per mm³ Standard Deviation 174.4	144.8 cells per mm³ Standard Deviation 191.7	156.0 cells per mm³ Standard Deviation 151.5

PRIMARY outcome

Timeframe: Baseline to 12 months

Population: 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.

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.

Outcome measures

Measure	Total Study Population n=729 Participants 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.
Changes in CD4 Count Mean CD4 count at 12 months	392.0 cells per mm³ Standard Deviation 216.5	—	—
Changes in CD4 Count Change in CD4 count	170.4 cells per mm³ Standard Deviation 201.7	—	—

PRIMARY outcome

Timeframe: Baseline to 15 months

Population: 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.

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.

Outcome measures

Measure	Total Study Population n=701 Participants 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.
Changes in CD4 Count Mean CD4 count at 15 months	412.6 cells per mm³ Standard Deviation 240.5	—	—
Changes in CD4 Count Change in CD4 count	194.8 cells per mm³ Standard Deviation 228.5	—	—

PRIMARY outcome

Timeframe: Baseline to 18 months

Population: 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.

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.

Outcome measures

Measure	Total Study Population n=599 Participants 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.
Changes in CD4 Count Mean CD4 count at 18 months	429.7 cells per mm³ Standard Deviation 249.4	—	—
Changes in CD4 Count Change in CD4 count	222.2 cells per mm³ Standard Deviation 228.7	—	—

PRIMARY outcome

Timeframe: Baseline

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

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.

Outcome measures

Measure	Total Study Population n=1572 Participants 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 n=739 Participants Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.	Tablet Formulation n=781 Participants Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Viral Load Mean viral load	4.44 Log10 copies per ml Standard Deviation 1.26	4.49 Log10 copies per ml Standard Deviation 1.17	4.43 Log10 copies per ml Standard Deviation 1.31

PRIMARY outcome

Timeframe: 1 month

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.

Outcome measures

Measure	Total Study Population n=420 Participants 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 n=218 Participants Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.	Tablet Formulation n=175 Participants Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Viral Load	3.28 Log10 copies per ml Standard Deviation 1.08	3.42 Log10 copies per ml Standard Deviation 1.07	3.19 Log10 copies per ml Standard Deviation 1.04

PRIMARY outcome

Timeframe: 3 months

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.

Outcome measures

Measure	Total Study Population n=995 Participants 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 n=469 Participants Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.	Tablet Formulation n=478 Participants Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Viral Load	2.69 Log10 copies per ml Standard Deviation 1.00	2.86 Log10 copies per ml Standard Deviation 0.97	2.54 Log10 copies per ml Standard Deviation 1.00

PRIMARY outcome

Timeframe: 6 months

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.

Outcome measures

Measure	Total Study Population n=1093 Participants 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 n=506 Participants Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.	Tablet Formulation n=544 Participants Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Viral Load	2.40 Log10 copies per ml Standard Deviation 0.89	2.62 Log10 copies per ml Standard Deviation 0.88	2.21 Log10 copies per ml Standard Deviation 0.84

PRIMARY outcome

Timeframe: 9 months

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

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.

Outcome measures

Measure	Total Study Population n=918 Participants 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 n=406 Participants Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.	Tablet Formulation n=471 Participants Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Viral Load Mean viral load at 9 months	2.41 Log10 copies per ml Standard Deviation 0.96	2.65 Log10 copies per ml Standard Deviation 1.02	2.24 Log10 copies per ml Standard Deviation 0.88
Viral Load Change in viral load	-2.05 Log10 copies per ml Standard Deviation 1.42	NA Log10 copies per ml Standard Deviation NA Change from baseline LOCF analysis for participants receiving capsule formulation was performed at 18 months.	-2.21 Log10 copies per ml Standard Deviation 1.44

PRIMARY outcome

Timeframe: 12 months

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

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.

Outcome measures

Measure	Total Study Population n=444 Participants 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.
Viral Load	2.54 Log10 copies per ml Standard Deviation 0.92	—	—

PRIMARY outcome

Timeframe: 15 months

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

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.

Outcome measures

Measure	Total Study Population n=432 Participants 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.
Viral Load	2.49 Log10 copies per ml Standard Deviation 0.92	—	—

PRIMARY outcome

Timeframe: 18 months

Population: 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).

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.

Outcome measures

Measure	Total Study Population n=413 Participants 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.
Viral Load Mean viral load at 18 months	2.35 Log10 copies per ml Standard Deviation 0.84	—	—
Viral Load Change in viral load	-1.95 Log10 copies per ml Standard Deviation 1.42	—	—

PRIMARY outcome

Timeframe: Baseline, 9 months, 18 months

Population: 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.

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.

Outcome measures

Measure	Total Study Population n=1831 Participants 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 n=875 Participants Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.	Tablet Formulation n=899 Participants Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Laboratory Parameter Blood Glucose Baseline	4.87 millimoles per liter Standard Deviation 2.05	4.89 millimoles per liter Standard Deviation 2.83	4.85 millimoles per liter Standard Deviation 0.86
Laboratory Parameter Blood Glucose 9 months	4.92 millimoles per liter Standard Deviation 1.42	4.87 millimoles per liter Standard Deviation 1.38	4.99 millimoles per liter Standard Deviation 1.49
Laboratory Parameter Blood Glucose 18 months	NA millimoles per liter Standard Deviation NA Only participants who received lopinavir/ritonavir capsules were planned to be followed past 9 months.	5.07 millimoles per liter Standard Deviation 2.64	NA millimoles per liter Standard Deviation NA Only participants who received lopinavir/ritonavir capsules were planned to be followed past 9 months.

PRIMARY outcome

Timeframe: Baseline, 9 months, 18 months

Population: 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.

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.

Outcome measures

Measure	Total Study Population n=2288 Participants 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 n=1206 Participants Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.	Tablet Formulation n=1016 Participants Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Laboratory Parameter Transaminases AST - Baseline	38.9 international units per liter Standard Deviation 37.1	36.8 international units per liter Standard Deviation 32.1	41.4 international units per liter Standard Deviation 42.4
Laboratory Parameter Transaminases AST - 9 months	35.2 international units per liter Standard Deviation 33.0	34.8 international units per liter Standard Deviation 29.6	36.0 international units per liter Standard Deviation 36.9
Laboratory Parameter Transaminases AST - 18 months	NA international units per liter Standard Deviation NA Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.	36.4 international units per liter Standard Deviation 30.8	NA international units per liter Standard Deviation NA Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.
Laboratory Parameter Transaminases ALT - Baseline	41.0 international units per liter Standard Deviation 40.3	39.6 international units per liter Standard Deviation 38.7	42.6 international units per liter Standard Deviation 42.6
Laboratory Parameter Transaminases ALT - 9 months	39.8 international units per liter Standard Deviation 52.5	40.8 international units per liter Standard Deviation 44.8	39.0 international units per liter Standard Deviation 60.3
Laboratory Parameter Transaminases ALT - 18 months	NA international units per liter Standard Deviation NA Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.	42.0 international units per liter Standard Deviation 44.8	NA international units per liter Standard Deviation NA Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.

PRIMARY outcome

Timeframe: Baseline, 9 months, 18 months

Population: 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.

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.

Outcome measures

Measure	Total Study Population n=2288 Participants 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 n=1206 Participants Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.	Tablet Formulation n=1016 Participants Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Laboratory Parameter Lipids Total Cholesterol - Baseline	4.37 millimoles per liter Standard Deviation 1.50	4.48 millimoles per liter Standard Deviation 1.68	4.28 millimoles per liter Standard Deviation 1.35
Laboratory Parameter Lipids Total Cholesterol - 9 months	4.96 millimoles per liter Standard Deviation 1.81	5.07 millimoles per liter Standard Deviation 2.36	4.89 millimoles per liter Standard Deviation 1.25
Laboratory Parameter Lipids Total Cholesterol - 18 Months	NA millimoles per liter Standard Deviation NA Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.	5.01 millimoles per liter Standard Deviation 1.29	NA millimoles per liter Standard Deviation NA Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.
Laboratory Parameter Lipids HDL Cholesterol - Baseline	1.39 millimoles per liter Standard Deviation 0.84	2.17 millimoles per liter Standard Deviation 1.45	1.19 millimoles per liter Standard Deviation 0.44
Laboratory Parameter Lipids HDL Cholesterol - 9 months	1.53 millimoles per liter Standard Deviation 0.98	2.08 millimoles per liter Standard Deviation 1.64	1.32 millimoles per liter Standard Deviation 0.53
Laboratory Parameter Lipids HDL Cholesterol - 18 months	NA millimoles per liter Standard Deviation NA Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.	2.04 millimoles per liter Standard Deviation 1.94	NA millimoles per liter Standard Deviation NA Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.
Laboratory Parameter Lipids LDL Cholesterol - Baseline	2.50 millimoles per liter Standard Deviation 1.07	2.87 millimoles per liter Standard Deviation 1.10	2.29 millimoles per liter Standard Deviation 1.02
Laboratory Parameter Lipids LDL Cholesterol - 9 months	2.73 millimoles per liter Standard Deviation 1.07	3.11 millimoles per liter Standard Deviation 1.18	2.51 millimoles per liter Standard Deviation 0.95
Laboratory Parameter Lipids LDL Cholesterol - 18 months	NA millimoles per liter Standard Deviation NA Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.	3.09 millimoles per liter Standard Deviation 1.14	NA millimoles per liter Standard Deviation NA Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.
Laboratory Parameter Lipids Triglycerides - Baseline	1.65 millimoles per liter Standard Deviation 1.06	1.66 millimoles per liter Standard Deviation 1.11	1.64 millimoles per liter Standard Deviation 1.04
Laboratory Parameter Lipids Triglycerides - 9 months	2.20 millimoles per liter Standard Deviation 1.46	2.21 millimoles per liter Standard Deviation 1.49	2.17 millimoles per liter Standard Deviation 1.44
Laboratory Parameter Lipids Triglycerides - 18 months	NA millimoles per liter Standard Deviation NA Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.	2.13 millimoles per liter Standard Deviation 1.35	NA millimoles per liter Standard Deviation NA Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.

SECONDARY outcome

Timeframe: 9 months

For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.

Outcome measures

Measure	Total Study Population n=2288 Participants 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 n=1206 Participants Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.	Tablet Formulation n=1016 Participants Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Reasons for Discontinuation of Lopinavir/Ritonavir Number of participants discontinued	269 Participants	122 Participants	143 Participants
Reasons for Discontinuation of Lopinavir/Ritonavir Lost to Follow-up	167 Participants	61 Participants	104 Participants
Reasons for Discontinuation of Lopinavir/Ritonavir Adverse Event	24 Participants	14 Participants	10 Participants
Reasons for Discontinuation of Lopinavir/Ritonavir Withdrawal by Subject	7 Participants	6 Participants	1 Participants
Reasons for Discontinuation of Lopinavir/Ritonavir Treatment failure	4 Participants	2 Participants	2 Participants
Reasons for Discontinuation of Lopinavir/Ritonavir Other - Tuberculosis/TB treatment	4 Participants	4 Participants	0 Participants
Reasons for Discontinuation of Lopinavir/Ritonavir Other - Medication not available	3 Participants	2 Participants	1 Participants
Reasons for Discontinuation of Lopinavir/Ritonavir Other - Poor general condition	1 Participants	1 Participants	0 Participants
Reasons for Discontinuation of Lopinavir/Ritonavir Other - Increased triglycerides	1 Participants	1 Participants	0 Participants
Reasons for Discontinuation of Lopinavir/Ritonavir Patient Noncompliance	1 Participants	0 Participants	1 Participants
Reasons for Discontinuation of Lopinavir/Ritonavir Reason unknown	57 Participants	31 Participants	24 Participants

SECONDARY outcome

Timeframe: 18 months

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

For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.

Outcome measures

Measure	Total Study Population n=1206 Participants 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.
Reasons for Discontinuation of Lopinavir/Ritonavir Number of participants discontinued	352 Participants	—	—
Reasons for Discontinuation of Lopinavir/Ritonavir Lost to Follow-up	239 Participants	—	—
Reasons for Discontinuation of Lopinavir/Ritonavir Adverse Event	20 Participants	—	—
Reasons for Discontinuation of Lopinavir/Ritonavir Withdrawal by Subject	17 Participants	—	—
Reasons for Discontinuation of Lopinavir/Ritonavir Treatment failure	7 Participants	—	—
Reasons for Discontinuation of Lopinavir/Ritonavir Other - Tuberculosis/TB treatment	6 Participants	—	—
Reasons for Discontinuation of Lopinavir/Ritonavir Patient Noncompliance	4 Participants	—	—
Reasons for Discontinuation of Lopinavir/Ritonavir Other - Medication not available	3 Participants	—	—
Reasons for Discontinuation of Lopinavir/Ritonavir Other - Fatigue	1 Participants	—	—
Reasons for Discontinuation of Lopinavir/Ritonavir Other - Increased triglycerides	1 Participants	—	—
Reasons for Discontinuation of Lopinavir/Ritonavir Reason unknown	54 Participants	—	—

SECONDARY outcome

Timeframe: 9 months

Participants reported whether they had missed doses of their antiretroviral treatment.

Outcome measures

Measure	Total Study Population n=2288 Participants 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 n=1206 Participants Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.	Tablet Formulation n=1016 Participants Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Compliance With Lopinavir/Ritonavir Reported never missing a dose	1377 Participants	729 Participants	616 Participants
Compliance With Lopinavir/Ritonavir Reported missing one or more doses	853 Participants	459 Participants	361 Participants
Compliance With Lopinavir/Ritonavir Information not reported	58 Participants	18 Participants	39 Participants

SECONDARY outcome

Timeframe: 18 months

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

Participants reported whether they had missed any doses of their antiretroviral treatment.

Outcome measures

Measure	Total Study Population n=1206 Participants 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.
Compliance With Lopinavir/Ritonavir Reported never missing a dose	616 Participants	—	—
Compliance With Lopinavir/Ritonavir Reported missing one or more doses	578 Participants	—	—
Compliance With Lopinavir/Ritonavir Information not reported	12 Participants	—	—

SECONDARY outcome

Timeframe: 18 months

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.

Outcome measures

Measure	Total Study Population n=2288 Participants 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 n=1206 Participants Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.	Tablet Formulation n=1016 Participants Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Adverse Events Observed on Treatment With Lopinavir/Ritonavir. Total number of AEs with causal relationship	260 Events	175 Events	78 Events

Adverse Events

Total Study Population

Serious events: 46 serious events

Other events: 109 other events

Deaths: 0 deaths

Capsule Formulation

Serious events: 22 serious events

Other events: 77 other events

Deaths: 0 deaths

Tablet Formulation

Serious events: 22 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Measure	Total Study Population n=2288 participants at risk 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 n=1206 participants at risk Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.	Tablet Formulation n=1016 participants at risk Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Blood and lymphatic system disorders Anaemia	0.13% 3/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.17% 2/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Blood and lymphatic system disorders Haemolytic anaemia	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Blood and lymphatic system disorders Lymphadenopathy	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Blood and lymphatic system disorders Thrombocytopenia	0.09% 2/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Eye disorders Exophthalmos	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Eye disorders Iridocyclitis	0.09% 2/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.20% 2/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Eye disorders Mydriasis	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Gastrointestinal disorders Abdominal pain	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Gastrointestinal disorders Diarrhoea	0.17% 4/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.30% 3/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Gastrointestinal disorders Vomiting	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
General disorders Asthenia	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
General disorders Chest pain	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
General disorders Death	0.31% 7/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.17% 2/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.49% 5/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
General disorders Fatigue	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
General disorders Pyrexia	0.13% 3/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.25% 3/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Infections and infestations Acquired immunodeficiency syndrome	0.09% 2/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.17% 2/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Infections and infestations Acute sinusitis	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Infections and infestations Bronchitis	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Infections and infestations Cellulitis	0.09% 2/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Infections and infestations Cerebral toxoplasmosis	0.09% 2/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.20% 2/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Infections and infestations Encephalitis cytomegalovirus	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Infections and infestations Hepatitis C	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Infections and infestations Meningitis cryptococcal	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Infections and infestations Mycobacterium avium complex infection	0.09% 2/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.20% 2/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Infections and infestations Pharyngitis	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Infections and infestations Pneumocystis jiroveci pneumonia	0.09% 2/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.17% 2/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Infections and infestations Pneumonia	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Infections and infestations Septic shock	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Infections and infestations Tuberculosis	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Investigations Mycobacteria test	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Metabolism and nutrition disorders Cachexiae	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Metabolism and nutrition disorders Diabetes mellitus	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Musculoskeletal and connective tissue disorders Synovitis	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Nervous system disorders Cerebral haemorrhage	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Nervous system disorders Headache	0.09% 2/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.17% 2/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Nervous system disorders Hypoaesthesia	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Nervous system disorders Neuralgia	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Psychiatric disorders Completed suicide	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Psychiatric disorders Depression	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Psychiatric disorders Disorientation	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Renal and urinary disorders Renal failure	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Renal and urinary disorders Renal failure acute	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.09% 2/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Surgical and medical procedures Hospitalisation	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Surgical and medical procedures Thrombectomy	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Vascular disorders Deep vein thrombosis	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Vascular disorders Venous thrombosis	0.04% 1/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.

Other adverse events

Measure	Total Study Population n=2288 participants at risk 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 n=1206 participants at risk Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.	Tablet Formulation n=1016 participants at risk Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
Blood and lymphatic system disorders Anaemia	0.17% 4/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.25% 3/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Gastrointestinal disorders Abdominal pain	0.22% 5/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.17% 2/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.30% 3/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Gastrointestinal disorders Abdominal pain upper	0.35% 8/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.50% 6/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.20% 2/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Gastrointestinal disorders Diarrhoea	2.9% 67/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	3.6% 43/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	2.1% 21/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Gastrointestinal disorders Flatulence	0.13% 3/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.25% 3/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Gastrointestinal disorders Gastrointestinal disorder	0.17% 4/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.08% 1/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.30% 3/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Gastrointestinal disorders Nausea	1.7% 38/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	2.5% 30/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.69% 7/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Gastrointestinal disorders Vomiting	1.0% 24/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	1.4% 17/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.59% 6/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
General disorders Asthenia	0.44% 10/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.50% 6/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.39% 4/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
General disorders Fatigue	0.26% 6/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.33% 4/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Immune system disorders Drug hypersensitivity	0.13% 3/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.25% 3/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Investigations Weight decreased	0.13% 3/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.25% 3/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Metabolism and nutrition disorders Decreased appetite	0.17% 4/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.25% 3/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.26% 6/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.41% 5/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Nervous system disorders Headache	0.26% 6/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.41% 5/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Psychiatric disorders Depression	0.13% 3/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.25% 3/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Skin and subcutaneous tissue disorders Pruritus	0.22% 5/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.33% 4/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.10% 1/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.
Skin and subcutaneous tissue disorders Rash	0.13% 3/2288 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.25% 3/1206 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.	0.00% 0/1016 • Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules. 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.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER