Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use
- Conditions
- HIV-1 Patients
- Registration Number
- NCT01379703
- Lead Sponsor
- Abbott
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2288
Patients infected by HIV-1 infection who are either:
- Antiretroviral treatment (ART) naive or
- Had failed or had been intolerant to one previous combined antiretroviral treatment (cART), not including a Protease inhibitor (PI) (first-line pretreated without a Protease inhibitor) or
- Had failed or had been intolerant to one previous antiretroviral treatment ART, including one Protease inhibitor (first-line pretreated with a Protease Inhibitor).
A ritonavir-boosted Protease inhibitor PI is considered as treatment with one Protease inhibitor PI.
- Treatment with drugs at risk for interactions with lopinavir/ritonavir
- Uncontrolled AIDS defining disease
- Two or more previous Protease inhibitors (PIs)
- Participation in another study or clinical trial
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CD4 Count 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.
Changes in CD4 Count Baseline to 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.
Viral Load 18 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.
Laboratory Parameter Blood Glucose Baseline, 9 months, 18 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.
Laboratory Parameter Transaminases Baseline, 9 months, 18 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.
Laboratory Parameter Lipids Baseline, 9 months, 18 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.
- Secondary Outcome Measures
Name Time Method Reasons for Discontinuation of Lopinavir/Ritonavir 18 months For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
Compliance With Lopinavir/Ritonavir 18 months Participants reported whether they had missed any doses of their antiretroviral treatment.
Adverse Events Observed on Treatment With Lopinavir/Ritonavir. 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.
Trial Locations
- Locations (103)
Site Ref # / Investigator 57102
🇨🇿Brno, Czech Republic
Site Ref # / Investigator 5344
🇨🇿Prague 8, Czech Republic
Site Ref # / Investigator 56886
🇵🇱Szczecin, Poland
Site Ref # / Investigator 57064
🇷🇴Brasov, Romania
Site Ref # / Investigator 57063
🇷🇴Constanta, Romania
Site Ref # / Investigator 57068
🇷🇴Iasi, Romania
Site Ref #/Investigator 57105
🇷🇺Kemerovo, Russian Federation
Site Ref # / Investigator 57055
🇨🇿Hradec Kralove, Czech Republic
Site Ref # / Investigator 57052
🇨🇿Plzen, Czech Republic
Site Ref # / Investigator 57051
🇮🇱Tel-Hashomer, Israel
Site Ref # / Investigator 6127
🇱🇹Vilnius, Lithuania
Site Ref # / Investigator 56888
🇵🇱Krakow, Poland
Site Ref # / Investigator 57048
🇮🇱Haifa, Israel
Site Ref # / Investigator 56883
🇵🇱Gdansk, Poland
Site Ref # / Investigator 56932
🇷🇺Khanty-Mansiysk, Russian Federation
Site Ref # / Investigator 56943
🇷🇺Krasnodar, Russian Federation
Site Ref # / Investigator 57024
🇷🇺Murmansk, Russian Federation
Site Ref # / Investigator 56964
🇷🇺Norilsk, Russian Federation
Site Ref # / Investigator 56930
🇷🇺Perm, Russian Federation
Site Ref # / Investigator 57053
🇨🇿Usti nad Labem, Czech Republic
Site Ref # / Investigator 57050
🇮🇱Beer-Sheva, Israel
Site Ref # / Investigator 57049
🇮🇱Jerusalem, Israel
Site Ref # / Investigator 6190
🇵🇱Bialystok, Poland
Site Ref # / Investigator 56885
🇵🇱Bydgoszcz, Poland
Site Ref # / Investigator 56887
🇵🇱Chorzow, Poland
Site Ref # / Investigator 56882
🇵🇱Warsaw, Poland
Site Ref # / Investigator 6194
🇷🇴Bucharest, Romania
Site Ref # / Investigator 57062
🇷🇴Bucharest, Romania
Site Ref # / Investigator 57065
🇷🇴Targu Mures, Romania
Site Ref # / Investigator 57066
🇷🇴Timisoara, Romania
Site Ref # / Investigator 56963
🇷🇺Chita, Russian Federation
Site Ref # / Investigator 56923
🇷🇺Ekaterinburg, Russian Federation
Site Ref # / Investigator 56918
🇷🇺Chelyabinsk, Russian Federation
Site Ref # / Investigator 56944
🇷🇺Magnitogorsk, Russian Federation
Site Ref # / Investigator 56905
🇷🇺Saint Petersburg, Russian Federation
Site Ref # / Investigator 56904
🇷🇺Moscow, Russian Federation
Site Ref # / Investigator 6209
🇷🇺Moscow, Russian Federation
Site Ref # / Investigator 56889
🇵🇱Lodz, Poland
Site Ref # / Investigator 56884
🇵🇱Poznan, Poland
Site Ref # / Investigator 57022
🇷🇺Barnaul, Russian Federation
Site Ref # / Investigator 56921
🇷🇺Irkutsk, Russian Federation
Site Ref #/Investigator 57104
🇷🇺Irkutsk, Russian Federation
Site Ref # / Investigator 57028
🇷🇺Ivanovo, Russian Federation
Site Ref # / Investigator 57036
🇷🇺Izhevsk, Russian Federation
Site Ref # / Investigator 56948
🇷🇺Khabarovsk, Russian Federation
Site Ref # / Investigator 56907
🇷🇺Nizhniy Novgorod, Russian Federation
Site Ref # / Investigator 56942
🇷🇺Novosibirsk, Russian Federation
Site Ref # / Investigator 57029
🇷🇺Ufa, Russian Federation
Site Ref # / Investigator 57026
🇷🇺Yaroslavl, Russian Federation
Site Ref # / Investigator 56902
🇷🇺Moscow, Russian Federation
Site Ref # / Investigator 56909
🇷🇺Kazan, Russian Federation
Site Ref # / Investigator 57030
🇷🇺Kostroma, Russian Federation
Site Ref # / Investigator 56928
🇷🇺Krasnoyarsk, Russian Federation
Site Ref # / Investigator 56915
🇷🇺Orenburg, Russian Federation
Site Ref # / Investigator 57031
🇷🇺Orenburg, Russian Federation
Site Ref # / Investigator 56911
🇷🇺Rostov-on-Don, Russian Federation
Site Ref # / Investigator 56931
🇷🇺Samara, Russian Federation
Site Ref #/Investigator 57106
🇷🇺Krasnoyarsk, Russian Federation
Site Ref # / Investigator 57025
🇷🇺Lipetsk, Russian Federation
Site Ref # / Investigator 56906
🇷🇺Saint Petersburg, Russian Federation
Site Ref # / Investigator 57038
🇷🇺St. Petersburg, Russian Federation
Site Ref # / Investigator 6199
🇸🇮Ljubljana, Slovenia
Site Ref # / Investigator 57054
🇨🇿Ceske Budejovice, Czech Republic
Site Ref # / Investigator 57056
🇨🇿Ostrava, Czech Republic
Site Ref # / Investigator 6124
🇮🇱Kfar Saba, Israel
Site Ref # / Investigator 57047
🇮🇱Rechovot, Israel
Site Ref # / Investigator 7578
🇱🇻Riga, Latvia
Site Ref # / Investigator 56890
🇵🇱Wroclaw, Poland
Site Ref # / Investigator 56903
🇷🇺Ekaterinburg, Russian Federation
Site Ref # / Investigator 56945
🇷🇺Kaliningrad, Russian Federation
Site Ref # / Investigator 57037
🇷🇺Kemerovo, Russian Federation
Site Ref # / Investigator 56929
🇷🇺Novokuznetsk, Russian Federation
Site Ref # / Investigator 56926
🇷🇺Noyabrsk, Russian Federation
Site Ref # / Investigator 57033
🇷🇺St. Petersburg, Russian Federation
Site Ref # / Investigator 57034
🇷🇺Tula, Russian Federation
Site Ref # / Investigator 56920
🇷🇺St. Petersburg, Russian Federation
Site Ref # / Investigator 56908
🇷🇺Surgut, Russian Federation
Site Ref # / Investigator 56962
🇷🇺Togliatti, Russian Federation
Site Ref # / Investigator 56947
🇷🇺Tver, Russian Federation
Site Ref # / Investigator 57035
🇷🇺Tver, Russian Federation
Site Ref # / Investigator 56910
🇷🇺Tyumen, Russian Federation
Site Ref # / Investigator 56919
🇷🇺Tyumen, Russian Federation
Site Ref # / Investigator 56949
🇷🇺Ulan-Ude, Russian Federation
Site Ref # / Investigator 56914
🇷🇺Ulyanovsk, Russian Federation
Site Ref # / Investigator 57027
🇷🇺Vladimir, Russian Federation
Site Ref # / Investigator 56916
🇷🇺Volgograd, Russian Federation
Site Ref #/Investigator 57103
🇷🇺Vologda, Russian Federation
Site Ref # / Investigator 56946
🇷🇺Yakutsk, Russian Federation
Site Ref # / Investigator 7579
🇷🇸Belgrade, Serbia
Site Ref # / Investigator 6208
🇸🇰Bratislava, Slovakia
Site Ref # / Investigator 57042
🇺🇦Dnepropetrovsk, Ukraine
Site Ref # / Investigator 57043
🇺🇦Donetsk, Ukraine
Site Ref # / Investigator 57045
🇺🇦Kyiv, Ukraine
Site Ref # / Investigator 6191
🇺🇦Kyiv, Ukraine
Site Ref # / Investigator 57039
🇺🇦Odessa, Ukraine
Site Ref # / Investigator 57046
🇺🇦Kyiv, Ukraine
Site Ref # / Investigator 57044
🇺🇦Mykolaiv, Ukraine
Site Ref # / Investigator 57040
🇺🇦Simferopol, Ukraine
Site Ref # / Investigator 7576
🇬🇪Tbilisi, Georgia
Site Ref # / Investigator 57067
🇷🇴Craiova, Romania
Site Ref # / Investigator 57021
🇷🇺Kurgan, Russian Federation
Site Ref #/Investigator 57107
🇷🇺Kirov, Russian Federation
Site Ref # / Investigator 56913
🇷🇺Saratov, Russian Federation