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KaleEAST is a non-interventional, post-marketing observational study (PMOS) in which lopinavir/ritonavir is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No additional procedures (other than the standard of care) are to be applied to the patients.
The KaleEAST PMOS was conducted in a prospective, single-arm, multicountry, multicenter format. The study was carried out in two (2) parts: the first part was initiated in 2004 with the lopinavir/ritonavir capsule formulation, the second part started in 2006 after the lopinavir/ritonavir tablets had become available in the participating countries.
The aim of this post-marketing observational study was to obtain further data on clinical, biological, and virological outcomes, compliance and tolerability of Kaletra®-containing regimen during routine clinical use in the participating countries.
As this study is observational in nature, subject follow-up was not specified by the protocol but was left to the judgment of each physician within the 18 months period, which defines the survey for each participant. For indicative purposes, follow-up of each participant should enable approximately 7 visits during this period. These visits will take place at average intervals of 3 months, apart from the first visit following inclusion (usually at the end of the first treatment month) and apart from visits required because of intercurrent events. Participant visits were assigned as follows: Baseline/Day 0 (start of lopinavir/ritonavir treatment), Month 1 (day 1 to day 45), Month 3 (day 46 to day 136), Month 6 (day 137 to day 228), Month 9 (day 229 to day 319), Month 12 (day 320 to day 410), Month 15 (day 411 to day 501), Month 18 (day 502 to day 593). Each participant is planned to be observed during his/her lopinavir/ritonavir capsule containing treatment regimen for a maximum period of 18 months, and each participant is planned to be observed during his/her lopinavir/ritonavir tablet containing treatment regimen for a maximum period of 9 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single patients group | Single HIV-1 infected patients group |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| CD4 Count | 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. | Baseline |
| Changes in CD4 Count | 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. | Baseline to 1 month |
| Changes in CD4 Count | 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. | Baseline to 3 months |
| Changes in CD4 Count | 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. | Baseline to 6 months |
| Changes in CD4 Count | 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. | Baseline to 9 months |
| Changes in CD4 Count |
| Measure | Description | Time Frame |
|---|---|---|
| Reasons for Discontinuation of Lopinavir/Ritonavir | For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided. | 9 months |
| Reasons for Discontinuation of Lopinavir/Ritonavir |
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Inclusion Criteria:
Patients infected by HIV-1 infection who are either:
A ritonavir-boosted Protease inhibitor PI is considered as treatment with one Protease inhibitor PI.
Exclusion Criteria:
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KaleEAST is non-interventional, observational study in which Kaletra® is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regard to dose, population and indication.
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| Name | Affiliation | Role |
|---|---|---|
| Maja Hojnik, MD, PhD | Abbott International | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Ref # / Investigator 57102 | Brno | 639 00 | Czechia | |||
| Site Ref # / Investigator 57054 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tablets and Capsules or Oral Solution | HIV-1 infected participants who received both tablet and capsule formulations or oral solution. |
| FG001 | Capsule Formulation | Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Study Start Through 9 Months |
|
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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. |
| Baseline to 12 months |
| Changes in CD4 Count | 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. | Baseline to 15 months |
| Changes in CD4 Count | 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. | Baseline to 18 months |
| Viral Load | 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. | Baseline |
| Viral Load | 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. | 1 month |
| Viral Load | 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. | 3 months |
| Viral Load | 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. | 6 months |
| Viral Load | 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. | 9 months |
| Viral Load | 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. | 12 months |
| Viral Load | 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. | 15 months |
| Viral Load | 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. | 18 months |
| Laboratory Parameter Blood Glucose | 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. | Baseline, 9 months, 18 months |
| Laboratory Parameter Transaminases | 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. | Baseline, 9 months, 18 months |
| Laboratory Parameter Lipids | 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. | Baseline, 9 months, 18 months |
For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
| 18 months |
| Compliance With Lopinavir/Ritonavir | Participants reported whether they had missed doses of their antiretroviral treatment. | 9 months |
| Compliance With Lopinavir/Ritonavir | Participants reported whether they had missed any doses of their antiretroviral treatment. | 18 months |
| Adverse Events Observed on Treatment With Lopinavir/Ritonavir. | 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. | 18 months |
| České Budějovice |
| 370 87 |
| Czechia |
| Site Ref # / Investigator 57055 | Hradec Králové | 50005 | Czechia |
| Site Ref # / Investigator 57056 | Ostrava | 708 52 | Czechia |
| Site Ref # / Investigator 57052 | Pilsen | 305 99 | Czechia |
| Site Ref # / Investigator 5344 | Prague | 180 01 | Czechia |
| Site Ref # / Investigator 57053 | Ústà nad Labem | 40011 | Czechia |
| Site Ref # / Investigator 7576 | Tbilisi | Georgia |
| Site Ref # / Investigator 57050 | Beersheba | 84101 | Israel |
| Site Ref # / Investigator 57048 | Haifa | 31096 | Israel |
| Site Ref # / Investigator 57049 | Jerusalem | 91120 | Israel |
| Site Ref # / Investigator 6124 | Kfar Saba | 44281 | Israel |
| Site Ref # / Investigator 57047 | Rehovot | 76100 | Israel |
| Site Ref # / Investigator 57051 | Tel Litwinsky | Israel |
| Site Ref # / Investigator 7578 | Riga | Latvia |
| Site Ref # / Investigator 6127 | Vilnius | LT-10105 | Lithuania |
| Site Ref # / Investigator 6190 | Bialystok | 15540 | Poland |
| Site Ref # / Investigator 56885 | Bydgoszcz | 85-030 | Poland |
| Site Ref # / Investigator 56887 | Chorzów | 41-500 | Poland |
| Site Ref # / Investigator 56883 | Gdansk | 80-214 | Poland |
| Site Ref # / Investigator 56888 | Krakow | 31-531 | Poland |
| Site Ref # / Investigator 56889 | Lodz | 91-347 | Poland |
| Site Ref # / Investigator 56884 | Poznan | 61-285 | Poland |
| Site Ref # / Investigator 56886 | Szczecin | 71-455 | Poland |
| Site Ref # / Investigator 56882 | Warsaw | 01-201 | Poland |
| Site Ref # / Investigator 56890 | Wroclaw | 51-149 | Poland |
| Site Ref # / Investigator 57064 | Brasov | 500174 | Romania |
| Site Ref # / Investigator 6194 | Bucharest | 021105 | Romania |
| Site Ref # / Investigator 57062 | Bucharest | 030303 | Romania |
| Site Ref # / Investigator 57063 | Constanța | 900708 | Romania |
| Site Ref # / Investigator 57067 | Craiova | 200515 | Romania |
| Site Ref # / Investigator 57068 | Iași | 700116 | Romania |
| Site Ref # / Investigator 57065 | Târgu Mureş | 540394 | Romania |
| Site Ref # / Investigator 57066 | Timișoara | 300310 | Romania |
| Site Ref # / Investigator 57022 | Barnaul | 658610 | Russia |
| Site Ref # / Investigator 56918 | Chelyabinsk | 454052 | Russia |
| Site Ref # / Investigator 56963 | Chita | 672000 | Russia |
| Site Ref # / Investigator 56921 | Irkutsk | 664043 | Russia |
| Site Ref #/Investigator 57104 | Irkutsk | 664043 | Russia |
| Site Ref # / Investigator 57028 | Ivanovo | 153000 | Russia |
| Site Ref # / Investigator 57036 | Izhevsk | 426067 | Russia |
| Site Ref # / Investigator 56945 | Kaliningrad | 2360000 | Russia |
| Site Ref # / Investigator 56909 | Kazan' | 420000 | Russia |
| Site Ref # / Investigator 57037 | Kemerovo | 650056 | Russia |
| Site Ref #/Investigator 57105 | Kemerovo | 650056 | Russia |
| Site Ref # / Investigator 56948 | Khabarovsk | 680029 | Russia |
| Site Ref # / Investigator 56932 | Khanty-Mansiysk | 628002 | Russia |
| Site Ref #/Investigator 57107 | Kirov | 57107 | Russia |
| Site Ref # / Investigator 57030 | Kostroma | 156007 | Russia |
| Site Ref # / Investigator 56943 | Krasnodar | 350015 | Russia |
| Site Ref # / Investigator 56928 | Krasnoyarsk | 660049 | Russia |
| Site Ref #/Investigator 57106 | Krasnoyarsk | 660049 | Russia |
| Site Ref # / Investigator 57021 | Kurgan | 640007 | Russia |
| Site Ref # / Investigator 57025 | Lipetsk | 398043 | Russia |
| Site Ref # / Investigator 56944 | Magnitogorsk | 350015 | Russia |
| Site Ref # / Investigator 56904 | Moscow | 105275 | Russia |
| Site Ref # / Investigator 6209 | Moscow | 105275 | Russia |
| Site Ref # / Investigator 56902 | Moscow | 129110 | Russia |
| Site Ref # / Investigator 57024 | Murmansk | 183047 | Russia |
| Site Ref # / Investigator 56907 | Nizhny Novgorod | 603005 | Russia |
| Site Ref # / Investigator 56964 | Noril'sk | 663318 | Russia |
| Site Ref # / Investigator 56929 | Novokuznetsk | 654031 | Russia |
| Site Ref # / Investigator 56942 | Novosibirsk | 630000 | Russia |
| Site Ref # / Investigator 56926 | Noyabrsk | 629806 | Russia |
| Site Ref # / Investigator 56915 | Orenburg | 460035 | Russia |
| Site Ref # / Investigator 57031 | Orenburg | 460035 | Russia |
| Site Ref # / Investigator 56930 | Perm | 614000 | Russia |
| Site Ref # / Investigator 56911 | Rostov-on-Don | 344006 | Russia |
| Site Ref # / Investigator 57033 | Saint Petersburg | 190000 | Russia |
| Site Ref # / Investigator 56906 | Saint Petersburg | 190103 | Russia |
| Site Ref # / Investigator 56905 | Saint Petersburg | 191167 | Russia |
| Site Ref # / Investigator 56920 | Saint Petersburg | 196645 | Russia |
| Site Ref # / Investigator 57038 | Saint Petersburg | 196645 | Russia |
| Site Ref # / Investigator 56931 | Samara | 443041 | Russia |
| Site Ref # / Investigator 56913 | Saratov | 410009 | Russia |
| Site Ref # / Investigator 56908 | Surgut | 628400 | Russia |
| Site Ref # / Investigator 56962 | Tolyatti | 445846 | Russia |
| Site Ref # / Investigator 57034 | Tula | 300002 | Russia |
| Site Ref # / Investigator 56947 | Tver' | 170024 | Russia |
| Site Ref # / Investigator 57035 | Tver' | 170024 | Russia |
| Site Ref # / Investigator 56910 | Tyumen | 628602 | Russia |
| Site Ref # / Investigator 56919 | Tyumen | 628602 | Russia |
| Site Ref # / Investigator 57029 | Ufa | 450077 | Russia |
| Site Ref # / Investigator 56949 | Ulan-Ude | 670034 | Russia |
| Site Ref # / Investigator 56914 | Ulyanovsk | 432071 | Russia |
| Site Ref # / Investigator 57027 | Vladimir | 600023 | Russia |
| Site Ref # / Investigator 56916 | Volgograd | 400040 | Russia |
| Site Ref #/Investigator 57103 | Vologda | 160002 | Russia |
| Site Ref # / Investigator 56946 | Yakutsk | 677004 | Russia |
| Site Ref # / Investigator 57026 | Yaroslavl | 150000 | Russia |
| Site Ref # / Investigator 56923 | Yekaterinburg | 620102 | Russia |
| Site Ref # / Investigator 56903 | Yekaterinburg | 620115 | Russia |
| Site Ref # / Investigator 7579 | Belgrade | 11 000 | Serbia |
| Site Ref # / Investigator 6208 | Bratislava | 813 69 | Slovakia |
| Site Ref # / Investigator 6199 | Ljubljana | 1000 | Slovenia |
| Site Ref # / Investigator 57042 | Dnipro | 49115 | Ukraine |
| Site Ref # / Investigator 57043 | Donetsk | 83045 | Ukraine |
| Site Ref # / Investigator 57045 | Kyiv | 01015 | Ukraine |
| Site Ref # / Investigator 6191 | Kyiv | 01015 | Ukraine |
| Site Ref # / Investigator 57046 | Kyiv | 03115 | Ukraine |
| Site Ref # / Investigator 57044 | Mykolaiv | 54003 | Ukraine |
| Site Ref # / Investigator 57039 | Odesa | 565031 | Ukraine |
| Site Ref # / Investigator 57040 | Simferopol | 95006 | Ukraine |
| FG002 | Tablet Formulation | Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study. |
| COMPLETED |
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| NOT COMPLETED |
|
|
| 9 Months Through 18 Months |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Study Population | HIV-1 infected participants who received lopinavir/ritonavir (any formulation) during any part of the study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Number | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | CD4 Count | 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. | Mean CD4 count is based on number of participants in each group who had CD4 count results at Baseline. | Posted | Mean | Standard Deviation | cells per mm³ | Baseline |
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| Primary | Changes in CD4 Count | 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. | Change from baseline analysis is based on participants with CD4 count results available at 1 month. | Posted | Mean | Standard Deviation | cells per mm³ | Baseline to 1 month |
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| Primary | Changes in CD4 Count | 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. | Change from baseline analysis is based on participants with CD4 count results available at 3 months. | Posted | Mean | Standard Deviation | cells per mm³ | Baseline to 3 months |
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| Primary | Changes in CD4 Count | 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. | Change from baseline analysis is based on participants with CD4 count results available at 6 months. | Posted | Mean | Standard Deviation | cells per mm³ | Baseline to 6 months |
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| Primary | Changes in CD4 Count | 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. | Change from baseline analysis is based on participants with CD4 count results available at 9 months. | Posted | Mean | Standard Deviation | cells per mm³ | Baseline to 9 months |
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| Primary | Changes in CD4 Count | 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. | 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. | Posted | Mean | Standard Deviation | cells per mm³ | Baseline to 12 months |
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| Primary | Changes in CD4 Count | 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. | 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. | Posted | Mean | Standard Deviation | cells per mm³ | Baseline to 15 months |
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| Primary | Changes in CD4 Count | 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. | 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. | Posted | Mean | Standard Deviation | cells per mm³ | Baseline to 18 months |
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| Primary | Viral Load | 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. | Mean viral load is based on number of participants in each group who had laboratory results for viral load at baseline. | Posted | Mean | Standard Deviation | Log10 copies per ml | Baseline |
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| Primary | Viral Load | 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. | Posted | Mean | Standard Deviation | Log10 copies per ml | 1 month |
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| Primary | Viral Load | 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. | Posted | Mean | Standard Deviation | Log10 copies per ml | 3 months |
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| Primary | Viral Load | 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. | Posted | Mean | Standard Deviation | Log10 copies per ml | 6 months |
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| Primary | Viral Load | 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. | Change from baseline analysis is based on last observation carried forward for total study population (N=1341) and tablet formulation group (N=677). | Posted | Mean | Standard Deviation | Log10 copies per ml | 9 months |
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| Primary | Viral Load | 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. | Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. | Posted | Mean | Standard Deviation | Log10 copies per ml | 12 months |
|
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| Primary | Viral Load | 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. | Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. | Posted | Mean | Standard Deviation | Log10 copies per ml | 15 months |
|
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| Primary | Viral Load | 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. | 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). | Posted | Mean | Standard Deviation | Log10 copies per ml | 18 months |
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| Primary | Laboratory Parameter Blood Glucose | 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. | 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. | Posted | Mean | Standard Deviation | millimoles per liter | Baseline, 9 months, 18 months |
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| Primary | Laboratory Parameter Transaminases | 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. | 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. | Posted | Mean | Standard Deviation | international units per liter | Baseline, 9 months, 18 months |
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| Primary | Laboratory Parameter Lipids | 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. | 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. | Posted | Mean | Standard Deviation | millimoles per liter | Baseline, 9 months, 18 months |
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| Secondary | Reasons for Discontinuation of Lopinavir/Ritonavir | For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided. | Posted | Number | Participants | 9 months |
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| Secondary | Reasons for Discontinuation of Lopinavir/Ritonavir | For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided. | Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. | Posted | Number | Participants | 18 months |
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| Secondary | Compliance With Lopinavir/Ritonavir | Participants reported whether they had missed doses of their antiretroviral treatment. | Posted | Number | Participants | 9 months |
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| ||||||||||||||||||||||||||||||||||
| Secondary | Compliance With Lopinavir/Ritonavir | Participants reported whether they had missed any doses of their antiretroviral treatment. | Only participants receiving lopinavir/ritonavir capsules for followed for up to 18 months. | Posted | Number | Participants | 18 months |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Adverse Events Observed on Treatment With Lopinavir/Ritonavir. | 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. | Posted | Number | Events | 18 months |
|
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Total Study Population | HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution). | 46 | 2,288 | 109 | 2,288 | ||
| EG001 | Capsule Formulation | Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study. | 22 | 1,206 | 77 | 1,206 | ||
| EG002 | Tablet Formulation | Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study. | 22 | 1,016 | 34 | 1,016 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Exophthalmos | Eye disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Iridocyclitis | Eye disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Mydriasis | Eye disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Acquired immunodeficiency syndrome | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Cerebral toxoplasmosis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Encephalitis cytomegalovirus | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Meningitis cryptococcal | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Mycobacterium avium complex infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Mycobacteria test | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Cachexiae | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 12.1 | Systematic Assessment | Adverse event occurred in one of the 66 participants receiving both capsules and tablets, or oral solution. |
|
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment | One of the two adverse events occurred in one of the 66 participants receiving both capsules and tablets, or oral solution. |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hospitalisation | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
| |
| Thrombectomy | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment | One or more adverse events occurred in the 66 participants receiving both capsules and tablets, or oral solution. |
|
| Flatulence | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment | One or more adverse events occurred in the 66 participants receiving both capsules and tablets, or oral solution. |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment | One or more adverse events occurred in the 66 participants receiving both capsules and tablets, or oral solution. |
|
| Asthenia | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment | One or more adverse events occurred in the 66 participants receiving both capsules and tablets, or oral solution. |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 1-800-633-9110 |
| Adverse Event |
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| Treatment failure |
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| Patient Noncompliance |
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| Tuberculosis/TB treatment |
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| Fatigue |
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| Reason Unknown |
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| Data not reported |
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| Georgia |
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| Latvia |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Number of participants discontinued |
| |||||
| Lost to Follow-up |
| |||||
| Adverse Event |
| |||||
| Withdrawal by Subject |
| |||||
| Treatment failure |
| |||||
| Other - Tuberculosis/TB treatment |
| |||||
| Patient Noncompliance |
| |||||
| Other - Medication not available |
| |||||
| Other - Fatigue |
| |||||
| Other - Increased triglycerides |
| |||||
| Reason unknown |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Reported never missing a dose |
| |||||
| Reported missing one or more doses |
| |||||
| Information not reported |
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| Participants |
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